text:
Clinical Feasibility Study of Allium's Biliary Stent
The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2007 by Allium, Ltd..
Recruitment status was: Not yet recruiting
Recruitment status was: Not yet recruiting
Allium, Ltd.
Information provided by:
Allium, Ltd.
ClinicalTrials.gov Identifier:
First received: March 14, 2007
Last updated: NA
Last verified: March 2007
History: No changes posted
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Detailed Description:
The purpose of this study is to evaluate the safety and efficacy of the Allium Biliary Stent in malignant obstructions of the common bile duct.
|Malignant Obstruction of the Common Bile Duct
|Device: Allium Biliary Stent
|Study Type:
|Study Design:
|Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:
|A Clinical Feasibility Study to Evaluate the New Allium Biliary Stent, in Patients Suffering From "Malignant Biliary Duct Obstruction" (Endoscopic Insertion)
Further study details as provided by Allium, Ltd.:
Primary Outcome Measures:
- Body temperature measurement, patient comfort analysis, sonographic measurements of the duct channels, abdominal X-ray imaging of the stent, and blood tests will be performed at 24 hours, 30 days, 3, 6, and 12 months following stent insertion.
|Estimated Enrollment:
|Study Start Date:
|April 2007
|Estimated Study Completion Date:
|December 2008
Biliary duct stenoses are caused by intrinsic malignant disease of the common bile duct or by compression or infiltration of malignancies of the abdominal organs, i.e. pancreas, liver, stomach, duodenum, etc, or by iatrogenic reasons such as endoscopic biliary stone manipulations, biliary anastomoses or biliary duct reimplantation. In these diseases, a stent can be placed in the biliary duct canal to "open it" and relieve the obstruction. The Allium Biliary Stent is to be inserted into the biliary duct to allow free flow of biliary fluid from the liver to the duodenum by supporting the obstructed area of the biliary duct lumen, keep it open, and prevent its re-obstruction.
|Ages Eligible for Study:
|18 Years and older (Adult, Senior)
|Sexes Eligible for Study:
|Accepts Healthy Volunteers:
Inclusion Criteria:
- Patient is 18 years or older
- Patient has malignant obstructive jaundice
- Patient is unfit for surgery
- Patient is capable of giving informed consent
- Patient is willing to comply with study requirements
Exclusion Criteria:
- Patient has a benign biliary duct obstruction
- Patient cannot tolerate any form of antibiotic treatment
- Patient is currently receiving anticoagulation therapy
- Patient has history of illness, medication, or surgery that may affect the efficacy of the stent (e.g.: a previous surgical change in the anatomy of the common bile duct)
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00448006
Please refer to this study by its ClinicalTrials.gov identifier: NCT00448006
|Contact: Simon Bar-Meir, M.D.
|Sheba Medical Center
|Not yet recruiting
|Ramat Gan, Israel
|Sub-Investigator: Simon Bar-Meir, M.D.
|Principal Investigator: Carlos Simon, M.D.
|Sub-Investigator: Alon Lang, M.D.
|Sub-Investigator: Maor Lahav, M.D.
Sponsors and Collaborators
Allium, Ltd.
|Principal Investigator:
|Simon Bar-Meir, M.D.
|Sheba Medical Center
More Information
Additional Information:
Keywords provided by Allium, Ltd.:
ClinicalTrials.gov processed this record on September 21, 2017
Additional Information:
|ClinicalTrials.gov Identifier:
|NCT00448006 History of Changes
|Other Study ID Numbers:
|Study First Received:
|March 14, 2007
|Last Updated:
|March 14, 2007
Keywords provided by Allium, Ltd.:
ClinicalTrials.gov processed this record on September 21, 2017


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Welcome to the week in wearable, where we round up the biggest happenings of the week.
It's been a crazy one with VR news from E3 in Los Angeles dominating the agenda – but there's plenty you might have missed. Let's catch you up.
Fitbit IPO values company at $4.1bn
Fitbit has registered the third biggest IPO of 2015, after raising over $732 million on its opening day of trading. That values the company at $4.1bn, which rose to over $6bn on Friday, as investors backed the company's huge sales in 2014 and early 2015.
Check out our in-depth look at how Fitbit grew to become one of wearable tech's biggest success stories, and of course, reviews of the Fitbit Charge HR and Fitbit Surge.
VR goes mad
There's been an absolute VR bonanza at E3 in Los Angeles, and while we reported that 10% of the 274 companies at the show were VR related last week, it's still been a busy week.
An industry analyst has predicted that 2.5 million VR devices will be sold in 2015 – rising to 24 million by 2018.
Meanwhile at E3, OSVR has added support for Android handsets, and newbie FOVE has revealed that it will support Valve's Steam VR on its indie headet.
Make sure you check out our first look review of Microsoft HoloLens and Sony's Project Morpheus.
Intel buys Recon
Intel has snapped up sports wearable manufacturer Recon Instruments. The maker of the Recon Jet and Recon was bought for an undisclosed figure, but joins Vuzix as recent eyewear acquisitions at Intel.
Check out our round-up of the best smartglasses as well as everything we're expecting from Google Glass 2.
Microsoft Band gets golf smarts
Microsoft has partnered with golf giant TaylorMade to add some serious smarts to the Microsoft Band. Like the dedicated golf smartwatches, or the multi-sport Garmin Vivoactive, the golf features on the Microsoft Band extends to distance to the pin and scorecard keeping.
Check out our review of the Microsoft Band, and our round up of the best fitness trackers.
NHS goes wearable
The NHS is looking at wearables to help keep an eye on vulnerable patients. The plans include using skin sensors, or smart clothes, which monitor health and upload information directly into patients' records.
It's not the only organisation getting involved in healthcare wearables. Check out our report on how Apple's ResearchKit is helping fight illnesses and the Apple Watch app that's taking the fight to cancer.
Wearable Forum kicks off
If that wasn't enough big news for the week, we saved the biggest for last. This week the Wareable Forum launched, your new place to chat about the latest wearable trends and innovation.
We wanted to create a forum for more discussion about this fantastic industry – so that's exactly what we did. Head over there and let us know what excites you in wearable tech.

subset: commoncrawl


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With most state legislative sessions coming to a close at the end of April, the action on voting rights in 2016 is shaping up to be very similar to last year. Following nearly a decade of consistent and growing attacks on voting rights, we're continuing to see some bright spots.
Leagues across the country can expect to have a busy 2016 legislative session, with the majority of state legislatures beginning their sessions in January. Many state legislatures will be debating critical issues, which could include possibly changing election laws in the middle of a major election year. This could create significant and unnecessary confusion for voters.
We have a day for giving thanks. We have Black Friday and Cyber Monday two-for-one deals. And now we have Giving Tuesday for giving back to the community! #GivingTuesday is propelled by those who believe that passion and commitment can make a difference.
Over the past 10 years, our country has seen a steady increase in the attacks on voting rights sweep across the states. From reductions in early voting opportunities to voter photo ID requirements to attempts to implement restrictions on the voter registration process, the attacks on our voting rights have been relentless. However, 2015 has bucked this trend.
EDITORIAL NOTE: This guest blog post was written by Ann Elwell, voter services chair of the League of Women Voters of Southwest Missouri
OK, let's admit it: Sometimes the same candidate forums that made the League of Women Voters famous can be a little... predictable, and a bit dry.
We are now two months into the 2015 State Legislative sessions and as expected we have seen a groundswell of assaults on voters in many states. At the same time, we are happy to report that there are a few states where pro-voter reforms are moving forward.
EDITORIAL NOTE: This guest blog post was written by Linda McDaniel and Kathleen Farrell, co-presidents of the League of Women Voters of St. Louis.
Other WorkSitemap


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People often wear jewelry as a form of self-expression--for instance, wearing a necklace tells people, "Hey, my neck is strong and goes all the way up." Decorate your décolletage with this Groupon.
$39 for Three Written Jewelry Appraisals ($270 Value)
Professional jewelers appraise, inspect, and clean three pieces of jewelry before sending customers home with a take-home cleaning kit.
Diamond Vault of Troy
Diamond Vault of Troy outfits clients with custom jewelry and engagement and bridal rings made with G.I.A.-certified diamonds. Its owners, Randall E. Cole and Timothy A. Mayer, personally source the diamonds directly from Antwerp every month in order to cut out the middleman and pass on substantial savings to their customers.
At the store, Cole and Mayer appraise clients' trinkets, clean and inspect jewelry, and evaluate pre-1964 silver coins, known for their high silver content. They prefer private personal appointments and provide children with coloring books and cartoons to keep them entertained while parents conduct their business and swap Crockpot recipes with the jewelers.
Diamond Vault of Troy's notable inventory includes engagement rings from Peter Storm and watches from Fendi, Steffen,Triton, and Faber-Castell. It also includes signature cut diamonds.


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Many Tucsonans will always remember where they were when they heard the news on Jan. 8: Our congresswoman has been shot.
But some are haunted by the memory of those terrible moments that changed Tucson forever. They were there.
With the violence all around, their gut reactions told them to run for safety. Then they thought about how to protect themselves, how to get help to those who needed it, and how to get word to loved ones.
Here are their experiences:
Staying alive
While standing in line waiting to meet Rep. Gabrielle Giffords, Randy Gardner struck up a conversation with a stranger, who turned out to be Phyllis Schneck, but they were interrupted by a series of popping noises.
Realizing it was gunfire, Gardner's vision became very narrow.
"Things just started to cave in on me," he said. "It was like tunnel vision. I never saw the shooter, I could only hear the sound and I knew I needed to get away from the sound. I saw forms of people moving, I heard screaming. I could see that people were falling to the ground."
Gardner, 60, suffered a gunshot wound to the foot.
"All I could think was 'OK, I'm going to try to get out of this situation.' "
Gardner eventually made it out to the parking lot where he took cover behind a vehicle. An employee who was outside and called 911 helped him into a nearby Walgreens where he laid on the floor waiting for help.
He was taken to UMC, where he was treated and kept overnight.
Hiding inside Safeway
Sharon Brillhart wanted to treat her 15-year-old son to some doughnuts.
Making her way to the express checkout line, she heard a sound like popping bubble wrap.
People were running to the back of the store. Workers in the pharmacy were rolling down the security window. Someone said something about a gun. Brillhart, 53, ran to the back of the store with 20 or 30 strangers.
Hiding amid pallets of boxed groceries, time moved slowly.
A woman called 911. "Hurry," she implored the dispatcher.
Brillhart called her son. She told him that people had been shot but she was safe and that she would call him again.
Police evacuated the store. Outside, Brillhart was shaking so hard she couldn't walk. She sat down and called her son again. She had heard they caught the guy, she said, and she would be home soon.
She left in her car to make room for emergency vehicles, but sat for half an hour in the traffic jam, watching people at the scene come and go, some on gurneys.
She drove through a Krispy Kreme on her way home, where she hugged her son.
Giving first aid
Forty-seven-year-old Bob Pagano, an optical engineer, saw Giffords and her staff as he walked into the Safeway where he's done his grocery shopping for 17 years.
"They were there, greeting people. She was smiling," Pagano said. "I thought it was nice to see people out like that on a Saturday morning."
Pagano was in the store for about five minutes when he heard what sounded like rapid fireworks.
"For a brief moment, I thought that was strange. Then I immediately ran out the door. Someone was shooting at a politician and I was angry," Pagano said.
As he ran outside, he saw several people lying on the ground. He saw a couple of people on top of the shooter. He called 911, but realized others were doing the same.
So he turned to help Pam Simon, who was shot in the chest and the wrist. She was lying face-down on the asphalt, about 15 feet from Giffords, who was already being helped by a young man who turned out to be Giffords intern Daniel Hernandez Jr. Pagano put his sweater under Simon's head to try to comfort her.
"She was very strong, she was telling me what to do. I was telling her she was going to be fine," Pagano said. "She was uncomfortable but entirely coherent."
He stayed with her as paramedics took over caring for her. Then he followed her to UMC, bringing her purse and other belongings with him. He stayed in the emergency department at the hospital until Simon's husband arrived.
The two met for the first time Friday in Giffords' office.
"I've just been amazingly pleased that she's doing so well," Pagano said of Simon. "She's a strong individual, an incredible person."
Calling for help
Giffords staff member Sara Hummel Rajca was taking pictures at the event when a young man in a hooded sweatshirt and jeans walked up and spoke with intern Daniel Hernandez Jr., standing a few feet away.
While Hernandez was still talking to him, the young man walked away, to the back of the line to see the congresswoman.
Hummel Rajca soon saw him again, a winter cap covering his nearly bald head. He walked up from the back of the line, stood next to Hummel Rajca, took out a gun and shot Giffords.
"That's when I ran," Hummel Rajca said.
"He was to my right. So I ran toward my left, which happens to be where my car was," she said. "I ran straight to my car and hid behind it."
"Once he shot that first shot, it was just like 'blam-blam-blam-blam.'"
She found her phone in the car and called 911. Twenty other people in the area did, too.
"After I called 911, I called my husband, and I started to call anyone I knew."
When she saw the shooter was restrained, she went back out to see if she could help. Then the police and ambulances arrived.
After emergency responders attended to the victims, police and FBI agents interviewed her and other witnesses, and she gave them some pictures she'd taken as the assigned photographer that day. The shooting started just after 10 a.m., and she was released at 2:30, feeling devastated.
Witnessing history
Howard Dow met some friends at Beyond Bread for a quick breakfast before their regular Saturday bike ride.
He was in the parking lot when the shots were fired. It sounded like fireworks - but, he wondered, why would someone set off fireworks in the morning?
As more and more shots rang out, he hid behind his car and then behind a brick pillar. People were running past, including an older man who was holding his leg from an injury.
It seemed like an eternity before authorities responded. In reality it was only a few minutes.
Police cars poured in. Then ambulances. Then three helicopters landed, one right after the other.
Seeing no way to help, the friends went on their bike ride. But Dow, 50, said the events have been playing on a continuous loop in his head.
"Everybody wants to witness history," he said, "but I could have done without that."
Contact reporter Becky Pallack at email@example.com or 807-8012.


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Rates on the most popular types of mortgages fell slightly, according to HSH.com's Weekly Mortgage Rates Radar.
The average rate for conforming 30-year fixed-rate mortgages declined by three basis points (0.03 percent) to 4.16 percent.
Conforming 5/1 Hybrid ARM rates fell by just one basis point, closing the Wednesday-to-Tuesday wraparound weekly survey at an average of 3.06 percent.
"Mortgage rates continue to confound expectations, easing for weeks despite signs of a growing economy," said Keith Gumbinger, vice president of HSH.com.
"But as we've seen so far this spring, low mortgage rates alone are insufficient to lift the housing market by much, or at least very quickly."
Sales of both new and existing homes have been tepid this spring as tight underwriting standards, a lack of desirable homes to buy, reduced affordability and other factors continue to keep the housing market from gaining much traction.
Average mortgage rates and points for conforming residential mortgages for the week ending June 3, according to HSH.com:
Conforming 30-year fixed-rate mortgage
Average rate: 4.16 percent
Average points: 0.16
Conforming 5/1-year adjustable-rate mortgage
Average rate: 3.06 percent
Average points: 0.07
Average mortgage rates and points for conforming residential mortgages for the previous week ending May 27 were, according to HSH.com:
Conforming 30-year fixed-rate mortgage
Average Rate: 4.19 percent
Average Points: 0.17
Conforming 5/1-year adjustable-rate mortgage
Average Rate: 3.07 percent
Average Points: 0.08
"Unlike refinancing, which is primarily interest-rate driven, the purchase of a home involves many more factors aligning," added Gumbinger.
"Mortgage rates are certainly a component, but finding a house you love, in a place you want to live, at a price you can afford, with all of the amenities and supports you need to be successful living there is a more complex process. Mortgage rates can go up and be a deterrent to buying or decline and be a stronger draw, but everything else must also come into alignment," said Gumbinger.


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L'Oréal Paris HiP Studio Secrets Professional Kohl Eyeliner Reviews
Ouch!Props to LOreal in the creativity department but I found the stiff but spongy applicator tip to be a little too pointy for the delicate eye area. The idea is cool -- a soft, powdery finish that glides on like a pencil -- but the applicator is too stiff. Also found application to be slightly messy and flaky. Boo. Wanted to like it. — 8 years, 3 months agoazspagirl | 45 reviews
Not loving thisI really do love L'Oreal Paris, especially the HiP products but this loose-powder liner is not for me! It's messy. I love the color options but the product application is not worth the effort or the price. — 8 years, 3 months agoamominred | 69 reviews
It's okayAnother cool new product from L'Oreal HIP are these kohl eyeliners. The applicator is a stiff felt tip which applies the loose pigment stored in the jar. The colors Navy and Gold are extremely wearable and in style for this season. I decided to be Santa for a day and gave some of these Kohl liners to my friends, they loved it! Check out what I like and dislike about the product below: PROS -Easy ...read moreto apply -Vibrant color payoff CONS -There is a bit of fallout after applying the product. Make sure to shake the excess powder off the applicator when you apply. -The large applicator might not apply the thinnest line. — 8 years, 3 months agomakeupbyrenren | 19 reviews
Moody Maria likes it!L'Oreal's HIP line is definitely for those who want High Intensity Pigment. I tried this eyeliner in black and gold. The eyeliner is actually a powder and is applied with a very fine spongy applicator. I think practice makes perfect with this applicator. First gather some powder, tap to remove excess and then slowly apply the powder. Don't be fooled- it is not eyeshadow and will stay in place! I ...read moreused too much the first time and had to remove a bit and smudge it to look less dramatic. For a night outing, this product is perfect! The gold color was a tad too intense for me for the daytime. I would definitely use it for evening and with turquoise shadow. It is really rich in color and vibrant! I loved using the product but I do think practice makes perfect and it is not a good product for moms that quick to run out the door! — 8 years, 3 months agomoodymaria | 42 reviews
Hate ItThese liners smudge too easily to wear for any length of time. I live in Northern Florida and I need products that are not effected by heat. These tend to travel from my upper, lower and waterline quickly and leave my face looking like a hot mess, which is not a good thing. I still love the L'Oreal HiP Creme Liners and I will continue to use those. These however are just not for me. — 8 years, 3 months agoShare | 20 reviews
tap off excess before usei actually like these. each is like using an eyeshadow as a liner, but instead of applying with a brush, you apply it with the fine, felt-tip applicator. they last long without smudging or smearing-- always a good thing-- but one thing i strongly advise when using these is to tap off the excess so the pigments won't fall onto your cheek. — 8 years, 3 months agobeauty_girl_musings | 136 reviews
Lovely Color, Perhaps Not for the Novice - Practice Makes Perfect!The first time I used this product, I had a problem with it. I didn't apply it very well, and some product ended up in under my contact and irritated my eye pretty badly. However, practice makes perfect with this applicator, and the more comfortable I got with it, the more I liked it. I've always liked a stiff brush for my liquid eyeliner, and many of the same benefits apply for a powder liner. If...read more you apply the hard applicator at an angle and drag it along the eye, you will get a beautiful, traditional kohl line that can be built on for more depth. The pigments are nice and dark, just the way I like them, and even on the lighter colors like gold, they don't get lost on the eye. To reduce fallout, which is a problem with any powder liner, in my experience, make sure to tap the applicator wand well against the bottle before pulling it completely out. — 8 years, 3 months agoRetrodiva | 159 reviews
Messy, Messy, Messy!The L'Oreal HIP (High Intensity Pigment) line, well overall I think the line is too youthful for those of us over 40. The colors are extremely vibrant and shocking. However, that being said there are a few things in the line worth taking a look at like this Kohl Eyeliner. I've been testing the shades charcoal and gold. The charcoal is a beautiful shade, the gold however just doesn't seem ...read moreto make sense to me as an eyeliner. It's more of a shadow color than liner color. The brush is built into the package and it is a very stiff brush that rather frightened me to put it near my eye, thinking clumsy me would poke an eye out! I thought that maybe this was a liquid, but when I opened it I realized - oh no, it's a powder, and a powder that flakes all over. Personally, I am not loving this product. If the brush was more soft and manageable and the powder stuck to the brush better instead of flaking all over, it'd be a great product. I just don't have time to deal with the mess to make it look great. — 8 years, 3 months agofabulousover40 | 88 reviews
9 out of ten - one flawI'm really surprised the product got such a low rating from a lot of people. Well, like I mentioned in my review of L'Oreal's HIP Color Presso lip gloss, I use a specific criteria to evaluate just about any beauty product. Aside for a product's particular features such as ingredients and package design, I use real practical evaluators to help me decide if a product is a "No" or a "...read moreGo." This is my 50 cents worth: This Eyeliner is so easy to apply, I couldn't believe how easy. I usually have to line my eye more than once to get a dark enough line to my liking. The Kohl Eyeliner is probably one of the best liners I've ever used. It applies better than an average liquid liner. My only usability critique is that the applicator tip could be softer. If you're like me and apply your eyeliner to the inner rim of the bottom lid, then you could appreciate what I mean. This eyeliner is absolutely gorgeous against my brown skin. It gives a beautiful gold shimmery tone in one fell swoop. No negatives for likability here. As for staying power, The Kohl Eyeliner gets an "A". I tend to rub my eyes during the day (working on the computer all day) but the eye liner is still holding on by end of day. I realize others my have a different opinion of this product but I have to say that if nothing else, you HAVE to get the gold Kohl Eyeliner (just be soft handed putting it on). I didn't even think I would like how this eye liner would look on me but I am really feeling it minus it's one negative. — 8 years, 3 months agoReviyve | 16 reviews
Very PigmentedThe pigmentation of these kohl liners from L'Oreal HiP is really good. I feel like using a high end product. I got Navy Kohl and Gold Kohl liners, one for everyday use and the other for summertime. The applicator is tricky to use at first but once I got a hang of it, I can make a good thin line or a thick one. However, as these are in powder form, they fall out a lot. While the fall outs from Gold Kohl look like highlighters on my cheeks, the ones from Navy Kohl are too obvious. — 8 years, 3 months agoDao | 19 reviews
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My Reasons for Reporting This


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Volume III - 5.3 Types of Inspections
Other Laboratory Operations
Food and Drug Administration
- 5.3.1 Food Inspections
- 5.3.2 Drug Inspections
- 5.3.3 Team Inspections versus Solo Contract Laboratory Inspections
An establishment inspection is a careful, critical, official examination of a facility to determine its compliance with laws administered by FDA. Inspections may be used to obtain evidence to support legal action when violations of the law are found or they may be directed to obtain information on new technologies, good commercial practices or data for establishing other regulations, etc. The kind and type of inspections conducted will normally be defined by a Center program or assignment. There are comprehensive and directed inspections. Comprehensive inspections direct coverage to everything in the firm subject to FDA jurisdiction while a directed inspection focuses on the areas described in the Center program or assignment.
The types of inspections most analysts find themselves on are directed inspections of food or drug firms. On occasion, analysts will accompany consumer safety officers on the inspection of cosmetics, medical devices, and animal feed firms.
5.3.1 Food Inspections
The Food, Drug, and Cosmetic Act (FD&C Act) provides protection of the public from products that may be deleterious, are unclean or decomposed, or have been exposed to insanitary conditions that may contaminate the product with filth or may render it injurious to health. A food microbiologist, entomologist, chemist or sanitarian may participate in a team inspection of food manufacturers in order to evaluate and document insanitary conditions (e.g., filth and microbiological contamination), decomposition, adulteration with pesticides and industrial chemicals, or illegal use of color or food additives.
There are specific current Good Manufacturing Practice (cGMP) regulations that must be followed by food processing facilities under 21 CFR Part 110 "Current Good Manufacturing Practice in Manufacturing, Packing or Holding Human Food". Analysts need to review and become familiar with this section of the CFR. In addition, analysts need to assess that the water being used in contact with the product (contact water) is safe. Processing water includes water that is used for post-harvest treatment of produce, such as washing, cooling, waxing, and product transport. Water can be a carrier of many microorganisms including pathogenic strains of Escherichia coli, Salmonella, Vibrio cholerae, Shigella, Cryptosporidium parvum, Giardia lamblia, Cyclospora cayetanensis, Toxiplasma gondii, and the Norwalk and hepatitis A viruses. Even small amounts of contamination with some of these organisms can result in foodborne illness. Reusing processing water may result in the build-up of microbial loads, including undesirable pathogens from the crop.
Good Manufacturing Practices (GMPs) for water used for food and food contact surfaces in processing facilities are in Title 21 of the Code of Federal Regulations (CFR), sections 110.37(a) and 110.80(a)(1). 21 CFR 110.19 provides an exemption from the requirements in 21 CFR part 110 for establishments engaged solely in the harvesting, storage, or distribution of raw agricultural commodities.
The analyst needs to evaluate whether food contact services are cleaned and handled properly. Food contact surfaces may be sanitized by a process that is effective in destroying or substantially reducing the numbers of microorganisms of public health concern, as well as other undesirable microorganisms, without adversely affecting the quality of the involved product or its safety for the consumer.
The analyst will also need to assure that in the facility proper precautions are in place to reduce the risk for food contamination or cross contamination, personal protection is being used, proper handling of toxic compounds is being performed, and health conditions and pests are being addressed.
Food sanitation team inspections may also involve an entomologist or food sanitarian. During a team inspection at a food warehouse, the entomologist or food sanitarian may be able to lend expertise in identifying or documenting insect infestation or rodent contamination of food products during warehouse storage. For example, documentation and identification of whole insects, excreta pellets, urine stains, insect damage, and insect and/or rodent gnawing will be needed to support certain regulatory actions.
A microbiological inspection demands a thorough understanding of the critical factors associated with the production and testing of the product being inspected. During the inspection, a microbiologist needs to fully identify the likely sources and possible routes of microbiological contamination which includes but is not limited to the handling of the product and environmental conditions. The microbiologist will need to document temperature abuses and delays in processing steps that will affect the product, evaluate microbial testing of the incoming product component(s) or of the finished product(s), and focus on positive findings of pathogenic microorganisms. Determine if equipment is constructed or covered to protect contents from dust and environmental contamination. Determine what equipment is present in the laboratory and if it is usable for the purpose intended. If the firm uses a consulting laboratory, determine what tests are performed and how often. Review laboratory records for the period immediately preceding the inspection.
One of the common types of team inspections a microbiologist may participate in are Low acid canned food or Acidified food manufacturer inspections. The absence of oxygen, normal room temperature storage conditions, moisture and nutrients associated with low-acid foods favors growth of Clostridium botulinum. A failure to either destroy or control (by water activity or acidification) the germination and growth of spores of Clostridium botulinum because of improper manufacture, processing, or packing may result in the production of a toxin which causes the potentially fatal food poisoning known as botulism.
Low-acid canned foods and Acidified foods are subject to all of the requirements under the Federal Food, Drug, and Cosmetic Act and the Fair Packaging and Labeling Act. These laws require that foods be safe, clean, and wholesome, and that labeling be honest and informative. The processing of Low-acid canned foods must comply with the requirements of the Good Manufacturing Practice regulations (21 CFR Part 113). The processing of Acidified foods must comply with the requirements of the Good Manufacturing Practice regulations (21 CFR Part 114).
Sections 21 CFR 108 & 113 on Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers, and 21 CFR 114 Acidified Foods are of particular importance when conducting these types of inspections.
Another type of food inspection is a HACCP inspection. FDA's Seafood Hazard Analysis Critical Control Point (HACCP) program is set forth in 21 CFR part 123. These regulations require processors of fish and fishery products to operate preventive control systems for human food safety that incorporate seven principles of HACCP. Processors must, among other things, establish "critical control points" in their operations where they can most effectively maintain the safety of their products, systematically monitor the operation of those critical control points to ensure that they are working as they should, and keep records of the results of that monitoring. Processors also must develop written HACCP plans that describe the details and operation of their HACCP systems. Each processor may tailor its HACCP system to meet its own circumstances.
The regulations require processors to make their HACCP records and plans "for official review and copying at reasonable times" (§123.9 (c)). Finally, the regulations provide that fish and fishery products are adulterated under section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act if their processor fails to have and implement a HACCP plan when one is called for, or otherwise fails to meet any of the requirements of the regulations, including allowing the official review of records (§123.6(g)).
Another type of team inspection the analyst may participate in is a High-Risk Food inspection. High-Risk foods are foods that are susceptible to contamination by pathogenic organisms and that are essentially ready-to-eat; that is, they will not undergo a sufficient kill step by the preparer. Microbiologists are often asked to participate in cheese inspections. Some cheeses (primarily soft cheeses) have been linked to foodborne outbreaks and illnesses caused by Salmonella, Listeria monocytogenes, and Escherichia coli contamination. Consumption of Feta and Mexican-style soft cheese has been linked to a high rate of perinatal listeriosis. During the inspection, a microbiologist may be asked to review the testing of these pathogens.
5.3.2 Drug Inspections
There are several different types of drug inspections and each has a different focus. For example, a cGMP inspection determines if the laboratory is performing analytical testing in accordance with cGMPs. The scope of this type of inspection is broad and usually encompasses all product related operations. Pre-Approval inspections determine if the laboratory is performing analytical testing in accordance with cGMPs, human and animal drug application commitments, and the data submitted in the application is verified against the raw data. The scope of this type of inspection is narrow, and focuses solely on operations which impact the drug product mentioned in the application. Post Approval Audit inspections provide continuing coverage of approved products.
However, there are areas common to these inspections. As a chemist or microbiologist participating in a team inspection, these common areas may be used as a starting point during the inspection.
188.8.131.52 General Areas (Chemistry and Microbiology Inspections)
The following areas are typically covered during all pharmaceutical inspections when applicable. Depending on the assignment, not all of these general areas will be covered. However, these are considered the backbone of the pharmaceutical laboratory inspections. In addition, the United States Pharmacopoeia is useful source for information.
Accountability of Raw Materials and/or Samples
- Have an employee, preferably the person who actually works in this area and not management, explain the firm's receiving, sampling, assigning samples, and quarantine procedures.
- Visually examine the receiving area and storage rooms. Determine if the room is acceptable for the materials in storage or does the climate need to be controlled and if so, how. Examine the temperature control records.
- Review all pertinent Standard Operating Procedures (SOP) and compare with actual operations. Review physical records to determine compliance with the SOPs for this area.
- Examine methods with corresponding product specifications to determine acceptability. If a product specification is in question, discuss it with the review chemist or review microbiologist for the application. Product specifications are a Center issue and cannot be placed on a FDA-483.
- With the aide of the Investigator, select a product and lot number(s). Review all analytical data associated with this product. This includes raw material testing, in-process testing, finished product testing, and stability testing. Check calculations (or spreadsheets), transcriptions, and reviewer's signatures for errors and discrepancies.
- Ask for and review the raw data and notebooks associated with each test. Compare the raw data to the summary documents.
- Review method validation records to determine adequacy (See Method Validation section for guidance). Determine if the method used in the microbiology or chemistry laboratory is the same as the method that was validated.
- Compare all analytical results with product specifications. Determine whether raw material or products with non-compliant test results were released, retested, or reworked.
- Examine written procedures for retesting of failed product (for example, assay failure or sterility failure) and compare with actual laboratory practice. Evaluate if the written procedure is complete and usable (See Out of Specification/Product Failure section).
- Ask to see all initial positive sterility test results. If a manufacturer of aseptically filled products has never found an initial positive sterility result, there may be a testing issue.
- Microbiological testing may include an identification of colonies or isolates found during the Total Aerobic Plate Count test or enrichment testing. Review these documents.
- If the method was validated at another site, review the method transfer documents to determine if the transfer was a success (see Method transfer section for guidance).
- For ancillary systems, select an audit period for evaluation of water system testing and environmental monitoring of controlled areas for sterile products.
- Review bacterial endotoxin, and bioburden testing data for parenterals, and any objectionable microorganism testing for non-sterile drugs. The amount of testing performed on non-sterile drugs will depend upon the product and its intended use. The significance of microorganisms in non-sterile pharmaceutical products should be evaluated in terms of the use of the product, the nature of the product, and the potential hazard to the user.
- Media fill, environmental monitoring, sterility test results, and other data should be reviewed to assure the absence of slow growing organisms.
- Determine if raw materials are periodically retested to assure continued quality. Review the associated procedures to determine compliance.
- Determine if dehydrated media is being used for the preparation of media. Good practice includes the periodic challenge of prepared media.
- Review the methods being used for microorganism incubation to determine if they conform to those listed in approved or pending applications. Evaluate the time period used for sterility test sample incubation.
- Visually examine standard/controls storage conditions.
- Examine how indicator organisms are being stored.
- Review written procedures to determine how positive and negative controls are prepared. Good practice for such testing includes the use of known terminally sterilized or irradiated samples as a system control. Alternatively, vials or ampoules filled during media fills have also been used.
- Review the standard written procedures and compare with standard storage conditions and the use logs for compliance.
- Determine if the firm uses secondary or in-house standards. Evaluate whether the assay to determine potency and purity is complete and usable.
- Determine if the secondary or in-house standards are re-assayed periodically. Does the written procedure address how often this re-assay occurs? Is there sufficient data to determine if this re-test period is valid? Who performs the re-testing?
- Determine if the primary standard has expired.
- Determine how often volumetric solutions are standardized. Evaluate if this schedule is valid. Determine if commercially purchased standard solutions are standardized as well. Keep in mind that commercial standards solutions are not primary standards and need to be periodically re-standardized.
- Review standardization logs or records for completeness and compare with the written procedure for compliance.
Equipment and Facilities
- Visually examine analytical equipment for proper maintenance and upkeep. Determine if the calibration/qualification status meets the SOP.
- Obtain a list of analytical equipment that is in use if possible.
- Review instrument written procedures and compare with maintenance and calibration/qualification records for compliance.
- Determine if the calibration/qualification written procedure is valid. Should the instrument be calibrated/qualified daily, weekly, monthly, quarterly, yearly? Is there data to support this schedule? Does the procedure have specification limits, specific directions, and remedial action directions?
- Equipment should be evaluated with its intended use in mind. For example, dissolution apparatus dedicated to paddles, may not need to be calibrated with both paddles and baskets, and an autoclave used for a specified temperature range may not have to be calibrated at all temperature ranges.
- For sterile products the USP states, "The facility for sterility testing should be such as to offer no greater a microbial challenge to the articles being tested than that of an aseptic processing production facility". If possible and feasible, the analyst should actually observe how sterility testing is being performed by the laboratory analysts. Proper design would, therefore, include a gowning area and pass-through airlock. Environmental monitoring and gowning should be equivalent to that used for manufacturing product.
- Begin the inspection with a review of microbiological analyses being conducted and inspect the plates and tubes of media being incubated.
- Inspect the autoclaves used for the sterilization of media.
- Inspect ovens used for pyrogenation and washers used for stoppers.
Drug products are to remain potent throughout their expiry. Therefore, the firm needs to be able to show that their product still meets assay and other specifications throughout its life. In order to do this, stability programs are set up and product is tested on a predetermined schedule to assure it is still a quality product. This is also required by the cGMPs in 21 CFR 211.166(a). GMPs allow accelerated studies to be used to establish a tentative expiration date. However, real time stability studies are conducted at defined temperatures which reflect normal storage conditions. Stability should cover the physical, chemical, and microbial attributes of the drug substance. Validated stability indicating analytical procedures are to be used (See Stability Indicating Methods and Preservative Effectiveness Testing).
For real time stability studies, representative samples from a minimum of three batches are stored at the labeled temperature (e.g. room, refrigerated, frozen) for a period at least as long as the proposed expiration date. The recommended testing schedule is quarterly the first year, semiannually the second year, and yearly thereafter; yearly testing is considered the minimum.
Once a product is approved, firms are expected to maintain a continuing stability program by placing a representative sample from at least one batch a year in a room temperature stability program.
Temperature, humidity, light, air/oxygen may need to be controlled and documented within the specifications set by the stability program protocol. The product is stored in the packaging container(s)/closure(s) intended for marketing. Product containers are stored in such a way so that the product is in contact with as much of the inner surface of the container as possible; for example, a bottle of syrup would be laid on its side or inverted so that the syrup is in contact with both the bottle and the bottle cap.
For Active Pharmaceutical Ingredients, the retest date is the date after which a sample of the drug substance should be tested to ensure that the material is still potent for use. They are not required to have an expiration date.
- Visually examine the products in the stability chambers. Determine if the products are in the containers in which they will be marketed. Determine if the product is stored properly in the chamber. For example, liquids should be stored in both the upright and inverted positions.
- Evaluate the temperature and humidity controls and determine if they will deliver the correct heat and moisture. Are the controls standardized with NIST traceable temperatures devices and is there sufficient documentation to support this?
- Review stability written procedures and protocols and determine if the firm is in compliance.
- Review stability testing records and determine whether stability tests are performed as scheduled using stability indicating methods (See Method Validation section).
- For sterile products, an evaluation of final product stability at the specified expiration date should also be performed.
- Obtain a roster of laboratory employees.
- Examine training records for compliance with written procedures.
- Examine employees experience and training records and evaluate whether employees are qualified to perform job duties.
- Ensure employees' workloads are doable.
- Ensure analytical test, equipment calibrations, and sample accountability are thoroughly documented.
- Ensure analytical records are reviewed and signed off on by authorized personnel.
- Ensure all mark outs, crossovers, and errors are properly explained, initialed and dated in accordance with SOPs and GMPs.
Standard Operating Procedures (SOPs)/Written Procedures
- Examine laboratory SOPs and written procedures and evaluate for thoroughness and compliance with GMPs.
- Determine if SOPs are easily found by employees.
- Review implementation dates and sign-off dates.
- Determine if the SOP or written procedure that is to be used is actually being used by the laboratory analysts.
Method Validation, Stability Indicating Methods, and Preservative Effectiveness Testing
There are several guidance documents written about chemistry method validation. Note that some of these documents are still in draft form. Review of these documents is critical in order to gain an understanding of what method validation means and what the Agency's thinking is. The United States Pharmacopoeia also describes and defines the concept of method validation.
There are seven common threads throughout these documents: accuracy, linearity, range, precision, detection limit, quantitation limit, specificity, and ruggedness/robustness. Other factors listed in one or more of the documents include recovery, stability of solutions, and system suitability. Each factor is clearly explained in the references listed. Remember that all of these validation factors are not needed for each and every method. The amount of validation will depend on the type of method being validated and its intended use.
Table 1 Recommended Validation Characteristics of the Various Types of Tests
|Type of Tests / Characteristics
|Testing for Impurities
|Assay Dissolution (Measurement Only), Content/Potency
|Specific Tests
|Precision-Intermediate Precision
|Detection Limit
|Quantitation Limit
-Signifies that this characteristic is not normally evaluated.
+Signifies that this characteristic is normally evaluated.
1In cases where reproducibility has been performed, intermediate precision is not needed.
2Lack of specificity for an analytical procedure may be compensated for by the addition of a second analytical procedure.
3May be needed in some cases.
4May not be needed in some cases.
5Lack of specificity for an assay for release may be compensated for by impurities testing.
For microbiology methods, it would be virtually impossible to completely validate test procedures for every organism that may be objectionable, and methods need to be tailored to different types of products. It is essential to inactivate preservatives or inhibitory substances present in order to provide a better medium for damaged or slow growing cells. Other growth parameters include lowering the temperature and increasing the incubation time, which may provide a better survival condition for damaged or slow-growing cells.
The selection of the correct neutralizing agents is largely dependent upon the preservative, inhibitory substance, and formulation of the product under evaluation. If there is growth in the enrichment broth, transfer to more selective agar media or an enrichment agar may be needed for subsequent identification. The method should optimize the recovery of all potential pathogens. There are instances when the product may enhance microbial growth and this may need to be determined for various assays.
Stability Indicating Methods and Preservative Effectiveness Testing
A stability-indicating assay accurately measures the active ingredients, without interference from degradation products, process impurities, excipients, or other potential impurities. This may be demonstrated by performing stress studies, also called forced degradation. Stress studies expose the product and/or drug substance to acid and base hydrolysis, thermal degradation, photolysis, oxidation etc. The stress studies should demonstrate that impurities and degradants from the active ingredient and drug product excipients do not interfere with the quantitation of the active ingredient. Drug product stress testing (forced degradation) may not be needed when the routes of degradation and the suitability of the analytical procedures can be determined through use of the following:
- Data from stress testing of drug substance.
- Reference materials for process impurities and degradants.
- Data from accelerated and long-term studies on drug substance.
- Data from accelerated and long-term studies on drug product.
- Additional supportive information on the specificity of the analytical methods and on degradation pathways of the drug substance are found in literature sources.
Method Validation is also addressed in parts 211.160(a), 211.165 (e), 211.166 (a)(3) and 211.194(a)(2) of the GMPs. It is also addressed in various ICH (The International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use) documents.
There are four basic microbial tests for finished product and stability samples.
- Sterility Tests: For products such as sterile intravenous solutions and intrathecal injections.
- Bacterial Endotoxtin Tests (Limulus Amebocyte Lysate): Tests for the presence of endotoxins in injectable drug products and implanted medical devices.
- Antimicrobial Effectiveness Tests: For products containing preservatives to inhibit the growth of microorganisms such as nasal and ophthalmic products.
- Microbial Limits Tests: For products that must be free of certain microorganisms which may be Salmonella, E. coli, Pseudomonas, or S. aureus such as topically applied preparations.
For sterile products, microbial preservative effectiveness testing needs to be performed during stability studies. This test is usually later replaced by chemical testing. It is important to note that for sterile products, container/closure integrity needs to be assessed not only at the beginning of the study but also at the end to demonstrate that the product remains sterile.
Method Transfer
Method transfer occurs when a validated method is transferred from one group, site, or company to another. There needs to be a Method Transfer protocol/plan/procedure in place. This protocol outlines the testing to occur, the roles of the two laboratories, and defines the acceptable values for the transfer to be accepted. During the inspection, the data from the transfer should be reviewed and compared to the protocol to determine if the data meets the acceptance criteria. Typical instances when method transfer occurs are from the Research and Development (R&D) laboratory to the Quality Control (QC) laboratory, Site A to Site B when a product line is moved, and Company X to Company Y when a product is purchased by another company.
Out of Specification (OOS) Results
During the course of analytical testing, there will be times when results are generated that do NOT meet product specifications. It is imperative that the firm has a procedure in place to handle these occurrences. During the inspection, an analyst needs to obtain a list of all batches which had an OOS result as well as a list of all failure investigations performed. It is important that when reviewing data, raw data should be reviewed. Often passing results are obtained by averaging a passing result with an OOS result.
FDA regulations require that an investigation be conducted whenever an OOS test result is obtained. The purpose of the investigation is to determine the cause of the OOS. Even if a batch is rejected based on an OOS result, the investigation is needed to determine if the result is associated with other batches of the same drug product or other products. Batch rejection does not negate the need to perform the investigation. The regulations require that a written record of the investigation be made including the conclusions of the investigation and follow-up (21 CFR 211.192).
The FDA has published a draft guidance document to assist industry and FDA investigators and analysts when reviewing OOS investigations. The concepts mentioned in the guidance document apply to laboratory testing during the manufacture of active pharmaceutical ingredients, excipients, and other components and the testing of finished products to the extent that current good manufacturing practice (CGMP) regulations apply (21 CFR parts 210 and 211). The guidance discusses how to investigate suspect or OOS test results, including responsibilities of laboratory personnel, laboratory phase of the investigation, additional testing that may be needed, when to expand the investigation outside the laboratory, and the final evaluation of all test results.
5.3.3 Team Inspections versus Solo Contract Laboratory Inspections
For many of the inspections performed by analysts, most often the analyst will be part of a team. The team may consist of one investigator and one analyst or it may be comprised of two or more investigators and/or analysts. It may be a two person team or it may include multiple people such as investigators, chemists, microbiologists, and compliance officers. It all depends on the firm and the focus of the inspection.
As a team member, the analyst will be expected to follow the Investigations Operations Manual (IOM) and communicate with the lead investigator. The IOM can be found at http://www.fda.gov/ICECI/Inspections/IOM/default.htm. The electronic copy is the official version and should be referenced prior to performing an inspection.
The lead investigator is ultimately responsible for the inspection. However, an analyst needs to make sure that he or she is also aware of the objectionable conditions that the other team members are finding. Communication between team members is important. Manufacturing cGMP violations may also result in laboratory violations. The analyst will be responsible for writing their part of the FDA-483 Observations, but the lead investigator may change the wording to follow his/her style. In many instances, it is a give and take situation. When the investigator is rewording the analyst's observations, focus on whether the intent and meaning of the observation is the same. If the rewording changes the meaning or intent, clearly explain this to the investigator and work together to write the observation so all team members understand the objectionable condition.
If the analyst is performing an inspection of a contract laboratory, he or she may not have an investigator present. In this case, the analyst is acting as the lead investigator. This is a good reason for the analyst to familiarize him or herself with the IOM. The analyst will need to issue the FDA-482 Notice of Inspection upon entering the inspection site. Issuance of the FDA-483 is clearly explained in the IOM. While performing a "solo" inspection, extremely violative conditions may be found. Consult with the local district office management to determine the course of action. Documentary samples and/or physical samples may need to be collected and an affidavit and/or receipt for the sample may need to be issued. Some districts may choose to send an investigator out for this part of the inspection or the analyst may be asked to do this on their own. If the analyst is to proceed alone, he or she should consult the IOM for the proper procedure and paperwork, as well as, with the local investigation staff, determine the best course of action.
If an analyst is conducting a solo inspection, the following sections in the IOM are extremely helpful:
Subchapter 5.1 Inspection Information
Subchapter 5.2 Inspection Procedures
Subchapter 5.3 Evidence Development
Subchapter 5.4 Food
Subchapter 5.5 Drugs
Subchapter 5.6 Devices
Subchapter 5.7 Biologics
Subchapter 5.8 Pesticides
Subchapter 5.9 Veterinary Medicine
Subchapter 5.10 Reporting
These subchapters identify the basics of an inspection. In the case of Drug Inspections, the IOM outlines the general areas covered during inspections.


text:
Culling from multiple sources throughout the web, American and otherwise, the folks at SamMobile have put together an initial outline of what Samsung's new Galaxy smartphone will look like price-wise. Thankfully, as we expected and were hoping for, these quotes are not terribly outrageous; somewhere in the our projected range.
We've known for some time now of the S4's Canadian debut on May 3. Currently, we know for certain that wireless carriers Rogers and TELUS will offer the S4 on a three-year contract or without. Contract-less will cost CA$700. Those pre-orders are available now online and products will be shipped by April 26.
Thus far, six major U.S. carriers have confirmed to be hosting Samsung's flagship phone at some point in the quarter, if not at launch. Said carriers are AT&T, T-Mobile, U.S. Cellular, Verizon Wireless, Sprint and Cricket Wireless; with the S4's price and availability known for just AT&T and U.S. Cellular at this time.
AT&T is offering the new 16GB Galaxy for $200 with a two-year contract. Pre-orders became available on Tuesday and expected arrival date is May 3. U.S. Cellular likewise began accepting S4 pre-orders, for an identical $200 with two-year contract. But if free things interest you, U.S. Cellular is giving away a S Flip cover with their pre-ordered devices.
Leading the pack for a change, we believe that T-Mobile will see the S4 as soon as May 1, or at least a month before the smartphone reaches the shelves at Staples' stores on May 30.
The Galaxy S4 without a contract will run you $640; that's a 16GB SIM-free version. Pricing and availability speaking, the 32GB variant is still pretty tight under wraps. We'll keep you posted as details reveal themselves.
<Source: SamMobile>


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PRZOOM - /newswire/ -
Memphis, TN, United States, 2009/02/27 - Remote Backup Systems, the founder of the Online Backup industry, today announced the availability of its new Mercury Online Backup platform for Windows and Mac.
Mercury is a powerful, white-labeled Online Backup software system with features and functionality designed to compete with the most well-known consumer grade online backup services being sold today. It is being offered as a turnkey solution to companies who want to enter the booming Online Backup market.
We have been quietly perfecting Mercury for about 18 months, explained Rob Cosgrove, president and founder of Remote Backup Systems, It is a completely new product, designed for a different type of user (home and personal users) than our industry-defining RBackup Remote Backup software.
Completely brandable and localizable, Mercury is multi-lingual, extremely configurable, and designed specifically for use by MSPs as the foundation software for their Online Backup businesses.
We timed this announcement to coincide with a roll-out by one of our customers, said Cosgrove, BackUPMAX.com went online today, with their Personal Edition powered by Mercury, and their Business Edition powered by RBackup. We wish them great success.
Mercury starts at about US$50,000 plus customization, installation, and other fees. It runs on Windows 2003 Server and uses Oracle 11g as a back-end.
About Remote Backup Systems, Inc.
Remote Backup Systems, Inc. (remote-backup.com) is the global leader in providing turnkey online backup software solutions to businesses and IT Service providers. RBS defines success as providing leading edge functionality, best-in-class customer support, and an unwavering commitment to product quality and customer satisfaction. With a twenty-one year history in Remote Backup technologies, RBS is headquartered in Memphis, Tennessee.
Agency / Source: Remote Backup Systems, Inc.
Availability: All Regions (Including Int'l)
Traffic Booster: [/] Quick PRZOOM - Press & Newswire Visibility Checker
Distribution / Indexing: [+]


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When an exhibitionist and a voyeur combine, they might be lucky enough to form a rare, wonderful, and exciting relationship. This was the case for photographic artist Victor Navarre and his model and muse Vanessa Davis, when their mutual love and respect for extreme art and creative exploration, brought them together to author and share their passion and craft in the book Extreme Art Nudes.
Readers will witness a new take of extreme art as both authors bravely take the classic nude female form out of the comfort and familiarity of the boudoir, while maintaining highly artistic presentation.


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Hewitt crashes out in Miami
Lleyton Hewitt bowed out of the Miami Masters 1000 tournament following a straight-sets loss to Gilles Simon.
Two-time major winner Hewitt, ranked 91 in the world, fell to the 11th-seeded Frenchman 6-3, 6-3.
Fifth-seeded Juan Martin del Potro departed Miami, falling 7-6 (7-5), 6-1 to 89th-ranked German Tobias Kamke in a second-round match disrupted by rain.
Del Potro had just dropped the first set when the match was halted by rain, the break lasting almost three hours.
The delay clearly did no favours to the world number seven from Argentina, who had stormed to the final of the Indian Wells Masters 1000 last week with wins over Andy Murray and Novak Djokovic.
His semi-final win over Djokovic in the California desert had ended the world number one's match winning streak at 22, but del Potro then fell to Rafael Nadal in the final.
Kamke next faces Austrian Jurgen Melzer, who beat Spain's Marcel Granollers 6-3, 6-4.
Djokovic progressed from the second round after thrashing Lukas Rosol of Czech Republic 6-1, 6-0.
Spanish third seed David Ferrer advanced by walkover into the third round when Russian opponent Dmitry Turnsunov withdrew with a stomach bug.
Ferrer will next face Italian 32nd seed Fabio Fognini, who beat Frenchman Michael Llodra in the second round 6-3, 6-1.
Serbian seventh seed Janko Tipsarevic also advanced by defeating Israel's Dudi Sela 6-2, 6-4, while the 12th-seeded Argentine Juan Monaco fell 6-2, 4-6, 6-3 to Spain's Albert Ramos.
Meanwhile, world number three Victoria Azarenka withdrew from the Miami WTA tournament due to a right ankle injury suffered last week.
Azarenka complained of ankle pain after a fourth-round victory over Urszula Radwanska in the Indian Wells quarter-finals last week and withdrew before she was to face Caroline Wozniacki.
"I am very disappointed that I am unable to compete this year in Miami," Azarenka said. "This is one of my favourite events and the Miami fans are always supportive.
"I have been working very hard to rehab my ankle this week but unfortunately it is still not fit to play. I look forward to returning next year."
Azarenka is unbeaten on court this year, a 17-0 run that includes the Australian Open and a title in Doha.
But she has twice surrendered matches by walkover, the first in January in a Brisbane semi-final against Serena Williams with an infected right toe that resulted from a pedicure.
Azarenka was replaced in the Miami draw by American lucky loser Lauren Davis.
Maria Sharapova shook off a lengthy rain delay and a mid-match power outage to beat Canadian Eugenie Bouchard 6-2, 6-0 in the second round.
The third-seeded Russian, who moved up to number two in the world on Monday after her triumph at Indian Wells, needed less than an hour to get past wildcard Bouchard.
She next faces compatriot Elena Vesnina, a 6-4, 6-2 winner over Croatian Donna Vekic.
Among other results, Germany's sixth seed Angelique Kerber downed Italian Francesca Schiavone 6-7 (5-7), 6-3, 6-2 and Russian 11th seed Nadia Petrova beat China's Zheng Jie 6-3, 6-1.
Topics: tennis, sport, united-states
First posted


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Wednesday, March 5, 2014
Why We Do What We Do
Do you ever go through a crafting dry spell (say, the length of a physically and emotionally rough first trimester...) and then when you finally sit back down to your sewing machine/yarn/pencil/camera/whatever your craft of choice may be, and, finally, with it back in your hands, you think, oh yeah. This is me.
Whenever I don't have the energy to make, it's because I've forgotten that making is what gives me the energy. Creating is what drives our humanity. The rest is just surviving.
More on this project when I've got it all done, but I have to say that the easy freehand nature of the quilting is so soothing and meditative. I highly recommend.
1 comment:
First of all, love the letters project! I think it is awesome. Kids love anything that they can physically feel, ya know - so it doesn't seem like they are actually learning something. ;)ReplyDelete
And secondly, I feel ya about the dry spell. I am not a crafter of any sort, but I feel that way about other things. Reading actually. I don't read anything for a while and I feel like, ugh, I don't have the time/energy to start something new, and then I do and I remember "oh yeah, I LOVE to read! Why do I go so long in between books?!"
And thirdly, is the 1st trimester we are reading about in regards to your precious firstborn Soph or is this a different 1st trimester that I have no idea about?!
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Houston's SXSW Strategy
South by Southwest is less a music festival than a force of nature, a ravenous beast that for one week in March consumes everything in its path and the surrounding countryside. But it's also like the old joke about the blind men and the elephant: it can be whatever you want it to be.
Some folks go through two boxes of business cards schmoozing from dawn till dusk (and vice versa), others use their Austin idyll as a working vacation — read: easy expense write-off, though perhaps not so easy this year — and others still as a graduate-level liver examination to see how much free booze that beleaguered vital organ can stand.
First at the Austin Chronicle and now at the Houston Press, Noise has never really bothered to develop a specific SXSW strategy. Since he's on the clock 24-7 this week anyway, he prefers to go where the four SXSW winds take him and see how many notebook pages that fills up — last year it was about 200, if memory serves. The old friends Noise always runs into randomly on the street or in line are without fail the best sources of SXSW insider gossip and hot band/party tips.
Peer into the SXSW maw all week long at blogs.houstonpress.com/rocks/sxsw.
To get an idea of what others are expecting from SXSW, though, Noise polled several members of this year's Houston delegation for both their musical and professional agendas. For the record, the only artists he's willing to stand in line for this year are New Wave techno-satirists Devo Friday at the Austin Music Hall and, since he missed them at Toyota Center last November, Me-fucking-tallica Saturday night at Stubb's — though, for that one, he figures he'll be able to hear just fine from the roof of Brackenridge Hospital.
Upcoming Events
MAGCON Tour
TicketsSat., Oct. 28, 12:30pm
Issues - Headspace Tour
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Hoodie Allen
TicketsSat., Nov. 4, 7:00pm
World Famous Gospel Brunch
TicketsSun., Nov. 5, 1:30pm
(Note: Showcase times are listed according to the day they begin; i.e., 1 o'clock Friday morning would be listed as 1 a.m. Thursday. Confusing, but that's SXSW for you.)
Matthew Wettergreen, Caroline Collective: "My goal is to highlight the successes we've experienced in Houston over the past year by using a community-focused model for improving conditions, and to demonstrate the wealth of talent and fertility of the Houston community — and not just music, but interactive, the tech people and the film community.
"I'm speaking on a panel at SXSW Interactive, and we're having a party celebrating all things Houston called Houston @SXSW, and it celebrates music, film and interactive; it's the first party of its kind to incorporate all three."
Looking Forward To: "I haven't finished all my research, so I'll just say I'm excited to see Houston bands playing to a national audience. Is that okay?"
Cley Miller, vocals/guitar, Young Mammals: "Our goal first and foremost is just to play our shows well and have a good time. Also, as far as attending goes, we just want to see as many bands [as we can] we wouldn't normally get to see. We want to check out a bunch of international acts.
"Last year, I tried to go [to the Convention Center], but was always too exhausted from the night before that I never made it out. This year, my goal is if I'm awake I'll try to go to the Convention Center and see what's going on. I remember last year I was like, 'I'm gonna go to this, this, this and this,' and didn't even make one."
Looking Forward To: "They've come through a bunch, but for some reason no one in our band has ever seen Dirty Projectors. There's a few bands from Germany that are coming, and a few Japanese bands. I've heard their music but can never remember their actual names."
Showcase: 8 p.m. Wednesday, March 18,at Spiro's, 615 Red River St.
Beau Beasley, bassist, Homopolice: "To be honest, I never in my life, and still at this point, want nothing to do with South by Southwest. I try to avoid it like the plague. This year was just a favor to a friend and it kind of mutated into something else. Once it's over, I plan to be back in Houston as soon as possible. I want to stay away. I think it's stupid."
Looking Forward To: "Nobody. I'd like to see Devo, but I'm not sticking around the whole fuckin' weekend just for that."
Showcase: 9 p.m. Wednesday, March 18, at the Scoot Inn, 1304 E. 4th St.
Cody Swann, vocals/guitar, Wild Moccasins: "One thing is I really want to play as much as we can and try to widen our audience. We've only played in Austin I think about four or five times now. I think we're going to be playing about eight — like seven day shows and our showcase. I'm hoping that we can increase our fanbase significantly and just get some experience doing that many shows back-to-back since we're going to be going on tour in June.
"I definitely want to try to make it out [to the Convention Center]. I haven't had a chance to look too much at some of the panels I'd be interested in going to yet, but I think I'm probably going to be using [last Wednesday] to see which bands I'm interested in going to see during our down time and which panels I want to go see. That's one thing that's slipped my mind, but I definitely think it would be for the good of the band."
Looking Forward To: "I'm definitely looking forward to seeing our Houston friends in a different setting. I think Music for Listeners from San Antonio is throwing a really good stage with, I think, [Delaware's] Spinto Band. Our showcase got moved to Wednesday, and this band Hot Lava — I think they're from Virginia. They're a really, really good pop band that I'm excited we're going to be playing after."
Showcase: 12 a.m. Wednesday, March 18, at The Tap Room at Six, 311 Colorado St.
B L A C K I E, experimental rapper: "I don't want to have to deliver pizzas again unless I want to. That's real. There's a few record labels and booking companies that I want to get down with, and my friend's bringing a generator. So I think I'm just going to find where they're having their things at, and just set up and play right in front of them. I'm better at doing that than talking to people."
Looking Forward To: "I want to see [Brooklyn indie-rockers] Grizzly Bear, but my girlfriend won't have a wristband or whatever, so she can't see 'em. She'd be all pissed if I see 'em without her. I want to see [Minneapolis rapper] P.O.S.; I've never seen him before. I want to see Juiceboxxx — if I was a white kid from Milwaukee doing the same thing that I'm doing, that's what he sounds like."
Showcase: 8 p.m. Friday, March 20, at Prague, 411-B Congress Ave.
Roy Head, Mr. "Treat Her Right": "I'm just going there to perform, actually. I'm not going there for the exposure — I've been exposed since 1957. I enjoy doing it, and I'm working for the Continental Club and a guy named Ira Pondas who has the Ponderosa Stomp. They call him Dr. Ike.
"I do a lot of things in New Orleans and New York and elsewhere. He asked me to come down and perform, and they're going to do kind of a documentary thing on an entertainer getting ready for a show. It's just going to be fun, plus there's a few dollars, which is always enticing."
Looking Forward To: "Basically, I'm not trying to sound egotistical or anything, but I just hang in until I do my part of the show, then I'm out of the city. There are so many groups there it's impossible to see everybody, and I'm not into the more wild stuff. I'm into blues and stuff like that."
Showcase: 12:20 a.m. Friday, March 20, at the Continental Club, 1315 S. Congress Ave.
Domokos Benczedi, guitar/general noise, Future Blondes: "To get paid. I don't know how much networking I'm going to get done this year. That was a goal, but now I'm really looking at my schedule and how it's going to work, and I don't know how it's going to happen. I have to do three different things. That's really not that many, but really, basically, to go get paid. Catch up with our traveling friends and keep on spreading our music.
"That's what I was looking at this year — to do more than just hang out and go party with friends, and actually give people that would be into what we're doing some packages. I've started to look into some symposiums and stuff, but I haven't really seen anything that would work yet."
Looking Forward To: "I don't know who I'm going to get to see, but Human Eye from Detroit, New York Dolls. Of course all of our friends — Balaclavas and all our crew. I haven't made my list yet."
Showcase: 8 p.m. Saturday, March 21, at the Independent, 501 N. IH-35.
Tom Nguyen, guitarist, The Tontons: "We're hoping to make a bigger impact this year, seeing how we were offered a better showcase. And hopefully just take advantage of all the benefits that come with South by. Maybe we'll get lucky and more press will be there. But I think just having more experience helps.
"We're going to try to go to some of the conferences there. We're playing two shows, and would have liked to play more, but it was kind of hard to get 'em all booked. Really, just network as much as possible."
Looking Forward To: "Devo, of course. I want to see [San Francisco's] Thao with the Get Down Stay Down. She's on Kill Rock Stars."
Showcase: 8 p.m. Saturday, March 21, Habana Calle 6 Patio, 709 E. 6th St.
Chaz Patranella, drummer, Balaclavas: "Shit, man, I don't know. Win the hearts and minds of the universe?"
Looking Forward To: "Indian Jewelry — we're playing the same showcase; that's gonna be good. I don't really know who's playing this year. We're playing with Six Finger Satellite, and that should be cool."
Showcase: 9 p.m. Saturday, March 21, at the Independent, 501 N. IH-35.
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Finally, I have moved more than halfway through my ready-to-sew garments from the summer. The latest is a little bit of Studio 54.
This is Hotpatterns Good Times Dress, which is inspired by a DVF style, and in a totally glam silk jersey. I might be having a silk jersey crush. It's so lovely and easy to sew, and skims the curves in a very flattering way.
I originally cut this dress for a friend who was performing in a 25-year reunion concert with her band. This was back in July and I didn't really have time to complete it but I probably needed an excuse to cut it out. I'd always wanted to try Hotpatterns as I've accumulated a few. I'd bought the lovely hibiscus-colored jersey from Gorgeous Fabrics over a year ago, for a project for another friend and we ended up going with something else. In the end, I really wanted that fabric (and dress) for myself anyway!
As you might notice, the dress remains unhemmed (the sleeves and hem will be about four inches shorter). This is because I've decided to put the dress in time out for awhile so I don't make any more holes or mistakes.
It took me a couple of days to figure out the yokes. The HP instructions have you roll up the bodice into its yoke "like a sausage" for a clean finish, much like the "burrito method" in shirtmaking. The problem with doing it this way is that the neckline is already closed, making it impossible to turn inside out. Ask me how I know–I had some kind of origami puzzle going on after sewing it according to the illustration.
To do this correctly, one must roll the entire garment (including the opposite yoke), into the yoke, sew and then turn out through the open armhole.
After figuring out the yokes, my serger started acting up. It needs a tune-up like last year. I kept ripping out a lot of serged stitches before I figured out that the problem was not with me or my needle but my machine. I wound up poking a big hole in the garment where the pocket goes, and had to sew over it.
I'm exaggerating by pulling on the dress but sometimes pockets in knits just don't lay well. I love pockets but might just serge them out of the picture when I come back to the dress.
The whole pattern is basically a bunch of rectangles, which I think is pretty clever in its simplicity. The sleeves are sewn in at right angles to the straight line of the shoulder. I'd probably call them kimono-style, with a square armpit. But I can't figure out how to sew that intersection of seams at the armpit without all the bunching and this is the point where I stopped before I ripped out yet another seam.
I love the proportions of the shapes in the dress. It has just a little bit of waist-shaping but otherwise relies on the drape of the fabric and ties for style.
I'm excited to see this done and will be back modeling this dress. It's too much pretty to waste.
In the meantime, I'm going to have to set aside the rest of my project list since most of it requires a fixed serger (except the bra) and I'm ready to get on with some fall sewing!


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Clint Riese
News Editor
Three women who participated in a parking lot prank involving their sister, a juvenile, will face charges.
Each of the three women face disorderly conduct and unlawful assembly charges. Both are misdemeanors.
The women – a 22-year-old from Forest Lake, a 25-year-old from South Carolina and a 27-year-old from Tennessee – admitted to staging a hoax in front of Walmart July 7. Security film showed the juvenile flee from the trunk of the parked car, only to be caught and forced back in. The car then sped away.
Forest Lake police treated the case as a potential kidnapping and directed many resources into the investigation. The mother of the four sisters called police the next afternoon and said the incident was a prank.
The Washington County Attorney's Office is still reviewing information regarding the juvenile.


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NEW YORK ( TheStreet) -- It's a challenge to define Oracle ( ORCL). Whatever it is, it's growing by leaps, bounds and acquisitions.
Perhaps that's why shares of this gargantuan of information technology, software development and hardware systems have done quite nicely in the last two quarter of 2013. Its shares trade around $38, as of Monday's close, and for the year to date they are up 14%.
Now Oracle wants to dominate the digital marketing business as well. Instead of pitching its products to big corporate executives and chief technology officers, ORCL is targeting its market campaigns directly to corporate divisions and individual departments, much like its main competitors.
Perhaps that's why on Dec. 20 it announced it would spend about $1.5 billion to buy Responsys ( MKTG), a barely profitable company that provides email and cross-channel marketing solutions that enable companies to engage in relationship-based marketing across various interactive channels.
Responsys offers its on-demand software and professional services to retail and consumer, travel, financial services and technology industries. It also sells to marketing agencies primarily through a direct sales force in North America, the Asia Pacific and Europe. The company was founded in 1998 and is headquartered in San Bruno, Calif.
This acquisition confirms earlier indications that Oracle is planning on going head to head against Salesforce.com ( CRM) and Adobe Systems ( ADBE) when it comes to how it sells technology solutions and IT services to a more targeted audience.
Responsys does that remarkably well. When you visit its Web site you can learn all the details.
The new school of marketing success is target marketing orchestration, and it is worth billions of dollars to technology purveyors such as ORCL. Earlier in 2013 ORCL bought another company that focuses on effective target marketing -- paying just under $1 billion for Eloqua, now the centerpiece of Oracle's marketing cloud.
This gives ORCL more innovative marketing automation and revenue management solutions to help modern marketers target the right buyers, easily execute campaigns, get the best leads to sales and deliver the highest return on its customers' marketing investment.


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John VanLeer's 300th career victory was a big one.
In a boys basketball contest between the two remaining teams in Four Rivers Conference play, Pacific took sole possession of first place with a 46-37 win over Sullivan.
"We're pretty evenly matched. They have great athletes who play super hard," VanLeer said. "We expected another tough game against them and that's what we got."
Milestone Win
In his 21st season as Pacific's head coach, VanLeer recorded his 300th career victory.
Scott Brown, VanLeer's assistant coach, has been there for all 300 wins.
"I've had kids who do what I ask them to do and play within the system. I've had a great administration who lets me do things my way and have supported me. We have a great community and we've had a great coaching staff," VanLeer said. "Having Scott with me for 21 years as an assistant coach is huge. I've always felt that I have the better coaches on the lower levels. Every coach on our staff, other than Coach Brown and Coach (Greg) Hrdlicka, played for me. Our little league program is good. My family has been very supportive."
Sullivan Head Coach Dino McKinney, another veteran coach in the FRC, praised VanLeer.
"John does an unbelievable job. It's a great accomplishment," McKinney said. "We've gone against each other a number of times. A few of those 300 wins have come at my expense. His kids always are prepared and play hard."
So does VanLeer have another 300 wins left in him?
"We'll have to pick up the pace for that to happen," VanLeer said. "I'm fired up every year, so I don't see myself not coaching. I love being around the kids and the competition."
Game Summary
Pacific (17-4) now stands with a 5-0 FRC record with games against Hermann and St. Clair remaining. Sullivan and St. James both are 4-1.
"Both teams we have left are good enough to beat us," VanLeer said. "We can't overlook anyone. "We have to keep getting better."
Sullivan (18-5) held leads of 13-8 after one quarter and 24-23 at halftime, but was outscored 23-13 in the second half.
"We missed too many free throws in the second half. We missed six or seven two-footers in the first half. In a game that's going to be close, you have to make those shots," McKinney said. "We've shot free throws well all year, but we were 2-12 in the second half."
Cullen VanLeer led the Indians with 17 points. Jeffrey Hinkle added eight points.
Tanner Brown finished with six points. Noah Boyer netted five points. Chris Klenke registered four points. Zach Kraus scored three points. Logan Armstrong had two points.
"We didn't play real well in the first quarter, but we started making plays and making shots. Those are things that good teams do. Good teams find ways to win," VanLeer said. "All 10 guys who played contributed in positive ways."
Justin Biermann paced Sullivan with 16 points.
Heath Schatz finished with nine points. Michael McDermott scored eight points. Chris Erxleben and Logan Hoffman both had two points.
"We handled their zone well, which is something we didn't do the last time we played them," McKinney said. "Defensively, we were pretty good. It was a physical game, which played in their hands. We've had a chance in all five of our losses, which is frustrating."
Pacific locked down defensively in the second half.
"They were patient and made us guard them. We weren't real focused defensively in the first half," VanLeer said. "We came out in our 1-3-1 to start the second half, but later went back to our man-to-man, which is our bread and butter."