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Thoroughly revised to include the latest industry developments, the Second Edition presents a comprehensive overview of computer validation and verification principles and how to put them into practice. To provide the current best practice and guidance on identifying and implementing improvements for computer systems, the text extensively reviews regulations of pharmaceuticals, healthcare products, blood processing, medical devices, clinical systems, and biotechnology. Ensuring that organizations transition smoothly to the new system, this guide explains how to implement the new GMP paradigm while maintaining continuity with current practices. In addition, all 24 case studies from the previous edition have been revised to reflect the new system. Key topics in Pharmaceutical Computer Systems Validation, Second Edition include: GAMP5, ASTM 2500, EU GMP (Annex 11), and US GMP revisions to regulatory requirements for electronic records and signatures that should be published in 2008 ICH Guidance Q8, Q9, and Q10 expectations FDA cGMPs for the 21st Century Initiative and associated guidance PIC/S Guidance on Good Practice for Computerized Systems in GxP Environments WK9864 Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment the indirect developments from FDA/EU/Japan regulators and industry the role of QA department, and internal and external suppliers the integration of computer systems validation into single overall approach for wider system practical guidance on handling common high, medium, and low risk issues that can occur during the life cycle of a computer system managing outsource partners and handling legacy systems topical issues uncovered by regulatory authorities including US FDAB. The instrument schedule is generated from an approved set of process and instrument diagrams (Paamp;IDs) ... safety devices including rupture disks, safety relief valves, dedicated safety shutdown systems [solid state or programmable logic controller (PLC)-based ... panel specification and drawings l Field junction box drawings l Electrical hookup (loop or wiring diagrams) drawings l Pneumatic hookupanbsp;...
|Pharmaceutical Computer Systems Validation
|Guy Wingate
|CRC Press - 2010-02-23


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Book Pin: The Lion, the Witch, and the Wardrobe
Wear your book on your sleeve! Or, maybe better, the lapel of your jean jacket.
With the Book Pins, I'm trying to capture the essence of a book in less than an inch square.
Each badge is a hard enamel lapel pin with raised nickel-plated outlines. It's about 1 inch tall by 0.75 inches wide, and attaches to your clothing with a black rubber clutch. It ships pinned to a small cardboard plaque.
This pin is of the first book in C.S. Lewis's amazing Narnia series, The Lion, the Witch, and the Wardrobe. It features the lamppost the Pevensie children see when they travel through the wardrobe for the first time, and where Lucy meets Mr. Tumnus.
Based on an original drawing by Jane Mount.

subset: commoncrawl


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April 1, 2013
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The black LLTM42-B 42 Tablet / Chromebook Charging Cart is a mobile solution for recharging and storing up to 42 tablets or Chromebooks for secure storage. They can be recharged with two 22-outlet vertical electrical assemblies. The cabinet has 1" rubber-coated partitions, which keep your laptops organized and protected. Ventilation is achieved with perforations on the sides, top, and bottom of the unit. The cart is transported by four 4" casters, two with locking brakes.
|4 x 4.0" (10.2 cm) full swivel casters, two with locking brake
|1.0" (2.5 cm) apart
|Dimensions (H x W x D)
|36.8 x 28.8 x 22.5" (93.5 x 73.2 x 57.2 cm)
|108.0 lb (49.0 kg)
|Packaging Info
|Package Weight
|110.0 lb
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|35.0 x 30.0 x 24.0"


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Lapid to battle Swedish anti-Zionism at upcoming rally
Yesh Atid chairman Yair Lapid is expected to address the pro-Israel community in Sweden, what is arguably the European country most hostile to Israel, on Sunday.Lapid will be the first-ever
Sattar cries foul after unofficial result declares PPP winner
KARACHI: Chief of MQM Pakistan, Dr Farooq Sattar, claimed in a press conference on Thursday that plans had been made to ensure MQM was defeated in the PS-127 by-polls. As
Dear Mr Bassie, I have recently been successfully sponsored by an employer in the United Kingdom. I would like to know what would happen to me if my sponsor loses
2400 Kilometres In A Ford Endeavour In 4 Days
It was a bad idea to drive through Rajasthan and Gujarat in the blazing summer but well, somethings have to be done and considering that the monsoons hadn't reached Gujarat;
Australian men arrive at court days after stripping at Malaysian Grand Prix
The nine Australian men who were arrested after stripping down to budgie smugglers during the Grand Prix in Malaysia have arrived at court. The men were stony faced and said
In triumph for Trudeau, China frees Canadian detained for years
Kevin Garratt, a Canadian held in China for two years on suspicion of spying, hugs his wife Julia Garratt after being deported by Chinese authorities, in Vancouver, British Columbia, Canada,


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Based on 72 guest reviews
Property Location
When you stay at Premiere Classe Creil - Villiers Saint Paul in Villers-Saint-Paul, you'll be within the vicinity of Chateau de Chantilly. This hotel is within the region of Parc Asterix.
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Economics 20A--bundle 2
Economics 20A--bundle 2 Econ 20A
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This 18 page Bundle was uploaded by Apurva on Monday February 1, 2016. The Bundle belongs to Econ 20A at University of California - Irvine taught by GLAZER, A. in Fall 2015. Since its upload, it has received 50 views. For similar materials see BASIC ECONOMICS I in Economcs at University of California - Irvine.
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Decor8ted (Decorated Theme) Theme: Genesis child theme for the stylish home, craft, hobby, design or fashion blogger. Comes with soft color combination and also mobile responsive that will adapt to any devices.
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After Vipassana, Heartfulness Meditation
Heartfulness meditation restores, uncovers, realizes our Heaven self. Inside simple inner peace there are worlds for us to discover. We don't have to take the word of others what the other side is like. We find the love of the other side on this side, in our hearts, in a life of greater heartfulness.


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Let's all just go home now. READ MORE »
Let's all just go home now. READ MORE »
Feeling freaky on this Friday afternoon? Check out this trailer for Karyn Kusama's award-winning thriller The Invitation, which opens on April 8th. All you need to know is that Will (Logan Marshall-Green) and his girlfriend Kira (Emayatzy Corinealdi) have been invited to a mysterious dinner party by Will's old friends David (Michiel Huisman) and Eden… READ MORE »
Nevermind is sold as a horror game about trauma that uses biofeedback to teach mindfulness – which means that it has overstretched itself. READ MORE »
Personally, I cannot get enough zombies between the epic television series "The Walking Dead" and now the announcement that there will be a third sequel to the "28 Days Later" franchise, it's like constant zombies in entertainment. They are my favorite horror genre by leaps and bounds!
The first movie of the trilogy… READ MORE »
I'd say that "The Eyes of Hitchcock" from video essayist kogonada is right in time for Halloween season, but let's be real, here, Hitchcock season is all year round. My best friend in high school indoctrinated me on Hitchcock, and this video illustrates beautifully why he's possibly the greatest director of all time. By today's… READ MORE »
This story is so full of WTF, I almost don't know where to begin. Two 12-year-old girls — their names have been published elsewhere, but as they are minors, I am choosing not to — are accused of stabbing another 12-year-old girl 19 times and then leaving her for dead in a Wisconsin woods. CNN said… READ MORE »
As PR for the new "Rosemary's Baby"-esque horror movie "Devil's Due," a prop studio equipped a remote-controlled baby carriage with a demon baby. They took it out into the streets and filmed concerned New Yorkers looked inside a carriage sitting by itself only to have a screaming, bloody-eyed devil baby suddenly pop up. As you… READ MORE »
From time to time, the local news coughs up a story that's basically the opening 20 minutes of a horror movie — in other words, the portion of the film between the opening credits and the scene where the doomed, 38-year-old high school cheerleader goes skinny-dipping.
Here are five tales from 2013 that… READ MORE »
I never much liked horror movies until I took a class in college called Gender and Sexuality in Horror Films (I was a Women's Studies major, so it didn't seem that weird at the time). We started with "Psycho" and "Peeping Tom" and worked our way up through the "Scream" franchise. Now I loooooove horror… READ MORE »
I never watch horror movies because I am a total scaredy-cat and it doesn't take much to give me serious nightmares (I slept in my brother's room for six months after seeing "Scream" in middle school). But over the years I've found that even if you avoid the horror genre altogether, there are plenty of… READ MORE »
Do you ever look at your lacy lingerie and think, "You know what this is missing? A picture of the Wolf Man."? If so, you definitely need to check out this vintage monster print garter belt from Etsy seller Voluscious. It's got all the big names in old school horror, including Dracula about to claim… READ MORE »
Now that's gotta hurt. UK street artist The Decapitator set about making a wackadoodle pop culture statement when he cut off Shakira's head. Posters featuring the cover of the November issue of Rolling Stone were decimated in this rather gory fashion. Not satisfied with this New York City sidewalk prank, the guerrilla artist produced fake… READ MORE »
"Jennifer's Body," a horror flick starring Megan Fox and written by Diablo Cody, is out September 19, which means it's time for another article postulating: "Why Do Women Like Horror Movies?"
Nice try, Entertainment Weekly, but, no, us girls don't like horror flicks for the "strong female leads," whomever those might be. Or… READ MORE »


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American teenager Emil Reinberg "loved" his first Wimbledon experience after succumbing in the second round of the Junior Boys Singles.
"I like playing on grass, but I know I need to make some improvements and keep working on my forehand."
Camila Giorgi offered no excuses after tumbling out in the third round of the Ladies Singles.
Giorgi, 23, went on to Court 1 with impressive victories over Lara Arruabarrena and Teliana Pereira under her belt but she was far from her best against the fifth-seeded Caroline Wozniacki.
Jonathan Erlich believes his epic run at Wimbledon will stand him in good stead for Israel's forthcoming Davis Cup clash against Slovenia.
Erlich and partner Philipp Petzschner set the men's doubles competition alight with some scintillating tennis after coming through the qualifiers, playing in their first tournament together.
There's been a real family feel around Wimbledon this week. First I had Jonathan Erlich telling me about the difficulty in spending time away from loved ones. Then, on the other side of the coin, American prodigy Emil Reinberg revealed he goes everywhere with his. Likewise Camila Giorgi, whose dad is rarely out of sight. He simply lives, eats and breathes tennis.
Jonathan Erlich's heroic run at Wimbledon ended at the semi-final stage after he and Philipp Petzschner were beaten in a four-set thriller on Centre Court on Thursday night.
The pair came through the qualifiers before mounting an excellent run in the Men's Singles but their hopes were shattered by Jamie Murray and John Peers.
Jonathan Erlich and Philipp Petzschner marched into the semi-finals of the Men's Doubles competition at Wimbledon.
Erlich of Israel and Petzschner of Germany upstaged second seeds Ivan Dodig and Marcelo Melo on Court 18.
Dodig and Melo took the first set 6-4 but Erlich and Petzchner rallied superbly to take sets two and three 6-2.
Emil Reinberg admits there is room for improvement after coming through a first-round thriller against Frederico Bonacia in the opening round of the Junior Boys Singles.
"It was tough because it was my first slam and I just kind of hung in there," said Reinberg.
Jonathan Erlich is on a mission to put Israeli tennis back on the map, but he wants to win the Men's Doubles title at Wimbledon first.
Having won the Australian Open in 2008 with Andy Ram, Erlich is this year partnering Philipp Petzschner, the 2010 champion, and he could face fellow Jewish player Scott Lipsky in round two.
Jonathan Erlich and Philipp Petzschner marched into the quarter-finals of the Men's Doubles competition after coming through a four-set thriller at Wimbledon on Saturday.
The Israel/German team overcame the challenge of Marcus Daniell and Marcelo Demoliner in a cracking contest on Court 7.
Camila Giorgi of Italy moved safely into the third round of the Ladies Singles following a straight sets victory over Lara Arruabarrena of Spain.
Giorgi, the last remaining Jewish player in the singles, breezed to a 6-0 win in the opening set, playing some flawless tennis.


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Provide differentiated instruction easily as students practice plotting points to create a baby chick for spring. The baby chick is available in both four quadrants. and Quadrant I only formats. CoordinArt makes a great quick and easy lesson plan especially when planning for a substitute.
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Perfectly Princess Baby Tights
Your baby girl will be dainty and adorable wearing these pink and black tights that feature a polka dot pattern with a pink silk flower detail on the side. The foot part is even designed to look like a Mary Jane shoe.


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We are open 3:30 to 6:30 pm today.
More information can be found here. October 8 through 31.
St. John's Lutheran Church884 Newfield AvenueStamford, Connecticut 06905Phone: (203) 322-0066Email:email@example.com
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Located on the edge of the magnificent cliffs of Petit Cul de Sac WV CMA
From $37,500 / week
Description from the manager
Description from the manager
Bedrooms: 6/
Bathrooms: 6/
Sleeps: 12/
Type: House
Book this 6 bedroom, 6 bathroom house in Saint Barthelemy today! A total of 12 people can sleep here comfortably.
Guests can enjoy a pool, hot tub, and outdoor grill among other amenities offered by this rental.
No travelers have shared a review of this property yet.
Costs vary, with the average weekly rate as low as $37,500.00 to as high as $193,600.00, depending on travel dates.
The owner last updated the property's calendar today.
About the manager
About the manager
Wimco Villas
Wimco Villas
- Response rate: n/a
- Response time: n/a
- Calendar updated: today
Overall rating:
4.7 / 5.0
Proximity to TripAdvisor's Top Saint Barthelemy Attractions
Proximity to TripAdvisor's Top Saint Barthelemy Attractions
Reviews (0)
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During the last 20 years, he has founded, financed and developed more than ten companies with total revenues exceeding US$1B. Among his most notable projects are Unitrade (retail), City.com (retail), Ukrainian Software Consortium (software), Softpress (publishing), Universal Telecom (telecom) and DK Zvyazok (media).
Andrey is founder and CEO in Divan.TV– the first OTT TV service provider, established in 2009 to provide its services to Russian-speaking community worldwide (300M people), including Ukraine and Russia.
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Andrey holds a PhD in Law from Koretsky Institute of State and Law (Ukraine) and bachelor degrees from Kyiv Politechnical Institute (Ukraine) and Kyiv National Taras Shevchenko University (Ukraine)
Andrey has been active in building the entrepreneurial community in Ukraine and Russia since 90s. In recognition of his efforts, the World Economic Forum nominated Andrey as a Young Global Leader in 2008.
He is fluent in GBEnglish RURussian UAUkrainian


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Active Ingredient: Lidocaine Hydrochloride (2.50%). Inactive Ingredients: Aloe Vera, Benzalkonium Chloride, Carbomer 980, Glycerol USP, Herbal Fragrance, Menthol, Polysorbate 20, Propylene Glycol, Purified Water, and Sodium Hydroxide (50%).
Clean the affected area. Adults and Children 2 Years of Age and Older: Apply small amount to affected area not more than 3 times daily. Children Under 2 Years of Age: Consult a doctor.
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I am having the problem that my machine is sometimes very busy with searching for the icons placed on the desktop. I know that there a possibility toclean the Icon cache under windows because i have done it once but i cant find it anymore.
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