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By virtue of the PCMO governance, there is a steering committee made up of PDA Advisory Board members and as well as a number of task forces. As part of the PCMO governance process, each topic is prioritized to maximize the value of the expected deliverables to pharmaceutical manufacturers of investigational medicinal products (IMPs) and commercial products.
Generally on PCMO project teams, an effort is made to incorporate membership from small, local to large, global pharmaceutical and biotechnology companies, technology enablers, and, in some cases, regulators from the US and Europe. There is an understanding among participants that PDA is working toward the common objective of delivering output that embodies the best experiences of our members and, in so doing, creating consensus-based approaches that are not only grounded on ICH principles, but also are pragmatic and scalable such that they can be implemented by any size of company.
PCMO projects
The PCMO portfolio of projects follows the product life-cycle concept and has the following broad strategic intent: Enable an innovative environment for continual improvement of products and systems Integrate science and technology into manufacturing practice Enhance manufacturing process robustness, risk-based decision-making and knowledge management Foster communication among industry and regulatory authorities.
Accordingly, PCMO projects have been grouped into four broad categories: life-cycle approach, quality systems, process management, and quality risk management. These categories are also consistent with ICH guidelines and with the focus of the majority of PDA technical reports and ongoing projects. There are currently 19 PCMO projects in progress (see Table I). Additional projects will be added as necessary to satisfy the needs of the industry as recognized by PDA membership and approved by its Advisory Boards.
Ingredients InsiderCynthia ChallenerFDA Approves Novel Treatments in 2014
Novasep has entered into an agreement with Celladon to provide scale-up and pre-validation studies for the drug substance for MYDICAR.
SGS Life Science Services adds analytical methods to identify amino acid impurities in bio/pharmaceutical manufacturing at facility in Germany.
The Pharma & Biopharma Outsourcing Association announced its support of legislation that would preserve FDA user fees from sequestration.
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Holdays.net Home
Aluminum Douglas Dakota DC 3 Airplane Model 25"
This expert level, highly detailed, museum quality, Douglas Dakota DC 3 aircraft model is brand new, fully built & assembled (not a kit). The manufacturer is Authentic Models (please see below).
The Douglas DC 3 airplane model is completely hand-built & handcrafted of aluminum etched metal sheets over a lightweight wooden frame. The wheels are metal and the tires are made of rubber.
This limited edition Dakota DC 3 model is highly detailed with extreme engine detail, windows, landing lights and even rivets are shown. The model aircraft can be displayed hanging from the ceiling, sitting on it's own landing gear or mounted on it's own solid cast aluminum stand (included).
This model is silver and there are no other markings. It is sure to become a conversational addition to your aviation decor and is the perfect size for hanging.
December of 2010 marked the 75th anniversary of the DC3's first flight.
The Douglas DC-3 is an American fixed-wing, propeller-driven aircraft whose speed and range revolutionized air transport in the 1930s and 1940s. Because of its lasting impact on the airline industry and World War II it is generally regarded as one of the most significant transport aircraft ever made. Many DC-3s are still used in all parts of the world.
The DC-3 was engineered by a team led by chief engineer Arthur E. Raymond and first flew on December 17, 1935 (the 32nd anniversary of the Wright Brothers' flight at Kitty Hawk). The aircraft was the result of a marathon phone call from American Airlines CEO Cyrus Smith to Donald Douglas requesting the design of an improved successor to the DC-2. Total production of the DC-3 was 16,079. More than 400 remained in commercial service in 1998.
With only three refuelling stops, eastbound transcontinental flights across the U.S. taking approximately 15 hours became possible. Westbound trips took 17 hours 30 minutes because of typical prevailing headwinds — still a significant improvement over the competing Boeing 247. Before the arrival of the DC-3, such a trip would entail short hops in slower and shorter range aircraft during the day, coupled with train travel overnight.
Early U.S. airlines like United, American, TWA and Eastern ordered over 400 DC-3s. These fleets paved the way for the modern American air travel industry, quickly replacing trains as the favored means of long-distance travel across the United States.
During World War II, many civilian DC-3s were drafted for the war effort and just over 10,000 US military versions of the DC-3 were built, under the designations C-47, C-53, R4D, and Dakota. Peak production was reached in 1944, with 4853 being delivered. The armed forces of many countries used the DC-3 and its military variants for the transport of troops, cargo, and wounded. The article "Douglas DC-3" is part of the Wikipedia encyclopedia. Models Inc was created more than 40 years ago in Amsterdam, the Netherlands. Authentic Model's expertise and interests go back many centuries. AM's collection of nautical ship models, furniture, artifacts and accessories is inspired by the age of exploration, maritime history, cartography and more…Learn more about Authentic Models Inc
More Fully Built WWI Biplane Fighters & Larger Plane Models by Authentic Models Are Available.
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subset: commoncrawl


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Ram Quixote was last seen: Viewing thread NFL Analysis: Rams' D-Line may disrupt NFC West, 5 minutes ago
Be careful what you wish for....oh wait, you have the Pink Floyd thread which is languishing due to inattention. Btw stop horning in on RQ's 15 minutes of ROD fame. Oh alright, here's one just for you with Spanish subtitles......come to think of it, English subtitles would help as well.


text: Important safety note for CDI sunglass users operating in proximity to fragmentation hazards: ESS strongly recommends the use of high-impact polycarbonate prescription lenses to optimize impact resistance in the CDI sunglass. Due to the variability of prescription lens shapes, materials, and thicknesses, it is impracticable to determine if the sunglass system is compliant with the ANSI Z87.1-2010 and MIL-PRF-31013 spectacle impact standards when prescription lenses are installed. High-impact polycarbonate prescription lens material will maximize the impact resistance of the system well beyond that offered by CR-39 resin or other common materials used in prescription lens manufacturing. No video currently associated with this product.No accessories currently associated with this product.This item can be found in the following sections: Home :: Brand Names :: ESS :: ESS Replacement Lenses :: ESS CDI Replacement Lenses :: ESS CDI Prescription Lens Frame Insert Home :: Products :: Safety Glasses :: (All) Safety Glasses :: ESS :: ESS Replacement Lenses :: ESS CDI Replacement Lenses :: ESS CDI Prescription Lens Frame Insert |


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In Extras!, Featured, Industry News, Uncategorized
Infineon's North America Road Trip Stops in New England
Posted By Christina Gerrish on Feb 24, 2015
Recently, Rochester hosted Steven Jeter and Chris Gillert of Infineon. While conducting business at their many North American locations, they made a point to visit Newburyport and tour the growing Rochester Electronics campus. Needless to say, both Steven and Chris were impressed with the vast expansions in manufacturing and sophistication of capabilities that is now [...]


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Hope on the Slopes for Cancer Research by Team We love Jackie - almost 2 years ago
"My wife was diognosed with Breast Cancer late last year. This 24 hours ski event is held annually to raise money and create awareness. Our team finished the 24 hours, we had over 120,000 vertical..." view full details


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General Homebrew Discussion / Re: What's Brewing This Weekend - 3/2 Edition
« on: March 04, 2013, 11:30:32 AM »
Possibly brewing a Doppelsticke to pour on the yeast cake from my Northern German Alt (Wyeast German Ale 1007) brewed Saturday before last. Might even step it up to a 10 gallon batch, as I have the capacity for it (SS Keggles, Mash Tun, Boil Pot). I've brewed this twice in the past 6 months, scored 42 @ the FOAM Cup in Tulsa, so its a pretty good recipe. The follow-up batch has been entered into the Bluebonnet Brewoff, but I was unable to register my brews for the NHC due to all of the problems they encountered. Maybe next year.....


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Article |
April 30, 1998
Pester USA: Stretchbander
A new Pester high-speed servo-controlled stretchbander from Rodico (Upper Saddle River, NJ) has cycle speeds reaching up to 40 bundles/min, allowing production of more than 200 bottles or cartons/min.
Handles oval or tapered bottles.
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Top Definition
Enjoyable in the most awesome way. Formed by the blending of the two words "uber" and "orgasmic". May also be spelled "übergasmic".
This steak is just ubergasmic!
by Gjermund
November 20, 2007
Type your email address below to get our free Urban Word of the Day every morning!
Emails are sent from email@example.com. We'll never spam you.


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We've been fans of Peter Beste's photography for many years now and especially of his Norwegian Black Metal series which he's been shooting for over 5 years now. Saturday evening he opens a new show of the photos @Articulated Gallery (inside the store Loved To Death 1681 Haight St.) 8pm-10pm - ~show details
SAN FRANCISCO --- Alexis Anne Mackenzie opens Multiverse at Eleanor Harwood in the Mission on Saturday, Feb 28th. -details


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The International Society of Automation (www.isa.org) is a nonprofit professional association that sets the standard for those who apply engineering and technology to improve the management, safety, and cybersecurity of modern automation and control systems used across industry and critical infrastructure. Founded in 1945, ISA develops widely used global standards; certifies industry professionals; provides education and training; publishes books and technical articles; hosts conferences and exhibits; and provides networking and career development programs for its 36,000 members and 350,000 customers around the world.
ISA owns Automation.com, a leading online publisher of automation-related content, and is the founding sponsor of The Automation Federation (www.automationfederation.org), an association of non-profit organizations serving as "The Voice of Automation." Through a wholly owned subsidiary, ISA bridges the gap between standards and their implementation with the ISA Security Compliance Institute (www.isasecure.org) and the ISA Wireless Compliance Institute (www.isa100wci.org).
Membership Benefits
Full ISA Membership
Automation Affiliate Membership
Student Membership
Earned Membership Grades & Reciprocal Memberships
Sunday, 26 Apr - Thursday, 30 Apr, 2015 Galveston, TX,
Monday, 11 May - Thursday, 14 May, 2015 Huntsville, AL,
Tuesday, 19 May - Thursday, 21 May, 2015 New Orleans, LA,
Sunday, 07 Jun - Thursday, 11 Jun, 2015 Kansas City, MO,
Thursday, 11 Jun - Friday, 12 Jun, 2015 Kansas City, MO,
ISA members have access to dozens of unique benefits. Update your member profile, set your communications preferences, find products and services that are right for you, and more – all from the convenience of your ISA website.
Featured Training: ISA Boot Camps
Featured White Paper: Workforce Development
Cover Story: Plant historians
Monday, 11 May - Thursday, 14 May, 2015 The Westin,
Tuesday, 19 May - Thursday, 21 May, 2015 Astor Crowne Plaza,
Sunday, 07 Jun - Thursday, 11 Jun, 2015 Kansas City Marriott Hotel,
Saturday, 13 Jun - Monday, 15 Jun, 2015 Raleigh Marriott City Center,
Monday, 09 Nov 2015 ,
ISA conducts its second annual FPID Symposium last week in Philadelphia Pennsylvania USA
Four ISA partners renew their agreements with ISA for 2015 emphasize the value and advantage of their partnerships
New book by Peter G. Martin, Ph.D., shows how industrial companies can unlock the true value and immense capabilities of automation systems
Make a difference in a girls life by introducing her to engineering
WisePlant HQ joins ISA Security Compliance Institute in support for the ISASecure cybersecurity conformance scheme
Beamex is pleased to announce its cooperation with Mark Draghicescu Racing at Silverstone race circuit
ISA and Beamex to co host web seminar on how to avoid the pitfalls of calibration system implementation
Honeywell Named Best Industrial Wireless Provider at 2014 Asian Manufacturing Awards
Beamex launches Mikes Calibration Corner
FDT Sponsors Webinar on Changes Needed for Successful Asset Management
ISA has the resources and expert networks that you need – no matter what position you hold in our industries. Browse the products and services designed to meet the needs of these common industry roles:
ISA gives me the chance to work with science and engineering students in my community. Each year, my section presents an award to a middle school team in the area who compete in a national engineering competition. I feel it's my responsibility to encourage young people to explore careers in automation and engineering.
-Peter Baker, ISA Twin Cities Section member
ISA's products and services are organized by technical topic – a selection of technologies, trends, and areas of focus that are relevant to your on-the-job performance:
Honorary Member: ISA's highest honor, recognized individuals, members or non members, whose support of and/or contributions to the advancement of the automation profession deserve special recognition.Life Achievement: Recognized an ISA member with a history of sustained dedication to the instrumentation, systems, and automation community.ArnoldO. Beckman Founder Award: Recognized individuals, members or non members, who made a significant technological contribution to the conception and implementation of a new principle of instrument design, development, or application.Albert F. Sperry Founder Award: Recognized individuals, members or non members, who made an outstanding technical, educational, or philosophical contribution to the science and technology of instrumentation, systems, and automation.Douglas H. Annin Award: Recognized individuals, members or non members, for an outstanding achievement in the design, application, or development of the components in an automatic control system from the input measurement through the final control element.E.G. Bailey Award: Recognized individuals, members or non members, for excellence in the design, development or application of instrumentation, systems, and automation in the utilities or process control industries.ISA Analysis Division Luft Award: Recognized an ISA member for outstanding contributions in the analytical technology field.Kermit M. Fischer Environmental Award: Recognized individuals, members or non members, for an outstanding achievement in the conception, design, and/or implementation of an application of instrumentation and/or automatic control in the field of environmental sciences, including applications for the enhancement or preservation of the environment.UOP Technology Award: Recognized individuals, members or non members, for an outstanding achievement in the conception, design, or implementation of instrumentation and/or process control in an area of activity covered by the scope of the Society's Automation and Technology Department.
Don W. Thompson Award: Recognized individuals, members or non members, for exemplary efforts and achievements to encourage and support student activity and to mentor students.Donald P. Eckman Education Award: Recognized individuals, members or non members, for an outstanding contribution(s) toward education and training in the science, engineering, and technology of instrumentation, systems, and automation.
Golden Achievement Award: Recognized ISA Members who had at least 25 years of continuous ISA membership and continuing active Society service and epitomized the membership and ideals of the Society.Distinguished Society Service Award: Recognized ISA Members who had at least 15 years of accumulated, devoted service and contribution to organizational units of the Society and its Members.Emerging Leader Award: Recognized ISA Members who, with no more than 10 years of accumulated membership, made significant contributions to organizational units of the Society and its Members. Years of student membership were not included in the limitation.Distinguished Friends of ISA: Recognized companies that, in the previous year, provided significant support to ISA and assisted the Society in achieving its goals and objectives.Excellence in Documentation Award: Recognized the author or co-authors of the most outstanding article, paper, or other document published by the Society in the previous year. At least one (co)author must be an ISA member.Outstanding Division Award: Recognized one Division from the Automation & Technology Department and one Division from the Industries & Sciences Department for outstanding activities and definitive reporting during the previous year.Section Performance Award: Recognized Sections for achievement or outstanding accomplishment in a particular area of Section activity.Standards & Practices Award: Recognized an ISA Member for an outstanding contribution to ISA's standards and practices effort.


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Teatro ZinZanni
29 Pier San Francisco CA 94111 On the EmbarcaderoStar This
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I wore a flapper style dress ! and a fun hat... Any style of attire is welcome but us ladies put some flair into it !.
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Pre-set menu was great. I would recommend not ordering any additional items.
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The booth seating were quite uncomfortable, and it was somewhat obstructed by a pillar
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There was metered 4hr parking (till 11pm) on Sansome and on Lombard.
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We took BART and walked along Embarcadero--20 minutes each way and felt perfectly safe.
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Next time, install iDrive with 1-click
Learn how MacUpdate Desktop can install apps on MacUpdate with the simple click of the icon. Plus, keep all your apps updated.
IDrive is a user-friendly, secure, and reliable application that performs automated online backup of your files and folders.
Note: You must first sign up to use iDrive.
The application safeguards your critical data in case of a system crash. The graphical interface is coupled with powerful scheduling and logging features.
- Incremental backups - only modified portions of files are backed up, thereby conserving bandwidth
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- Enhanced security with more...
What's New
Version 18.104.22.168:
- iDrive WiFi backup support
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- OS X 10.5 or later
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Use your will. Change the world
During 9–22 March, we're running our annual Make a Will Fortnight scheme to give you the chance to write or update your will for free.
Find out moreTorture in Mexico has increased by 600% over the last decade. Yet the Mexican government continues to deny it is even happening.
The Mexican president arrives in the UK this week and will meet the Deputy Prime Minister Nick Clegg and Foreign Secretary Philip Hammond.
Ask our politicians to speak out on Mexico's human rights record when they meet him.
We are ordinary people from across the world standing up for humanity and human rights.
Learn about what we doI would like to help today and donate
today, we delivered a #StopTorture message to #Mexico. Now we need you to ask UK to speak out: http://t.co/LuICwMczbw http://t.co/7lpPmM7p2J20 hours ago
RT @a_bacci: Thinking of #AlbertWoodfox and the @angola3news campaign today. Albert's bail hearing starts 9.30am CST. Fingers crossed. #Ang…21 hours ago
.@nick_clegg Don't turn a blind eye to torture in Mexico - tell President Peña Nieto he must speak out & #stoptorture http://t.co/3YChwD3Dty22 hours ago
.@PHammondMP Don't stay silent on torture in Mexico - tell President Peña Nieto he must speak out & #stoptorture http://t.co/3YChwD3Dty22 hours ago
Follow usDuring 9–22 March, we're running our annual Make a Will Fortnight scheme to give you the chance to write or update your will for free.
Find out moreMid or long-distance runner? Join Team Amnesty for the Brighton Marathon. Hurry! Registration closes Friday 6 March.
Find out moreJoin us for a weekend of inspiration and collaboration at our 53rd National Conference and Annual General Meeting on 18-19 April 2015.
Find out moreCelebrate the people who are making the biggest difference in the fight for environmental and social justice. Browse the categories and nominate today in the tenth Observer Ethical Awards.
Find out moreBecause of you people have been freed, lives have been saved and justice has been done. See some good news stories that show what a difference we can make.
Find out moreLocal Groups are at the heart of what we do. They offer powerful support to campaigns, raise vital funds and represent Amnesty in their local community.
Find out more© Amnesty International UK 2014 - Amnesty International UK is a company limited by guarantee registered in England no 01735872.
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You missed it This great deal for The Reef Playacar Beach Resort & Spa is over. But don't despair, we've got more great deals every day.
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Escape Kit
• A Four- ($520), Five- ($650), or Six-Night ($780) Stay for Two in a Deluxe Room from September 1 to October 31
• Or, a Four- ($600), Five- ($750), or Six-Night ($900) Stay for Two in a Deluxe Room from May 1 to June 30 or November 1 to December 20
• Or, a Four- ($650), Five- ($831), or Six-Night ($975) Stay for Two in a Deluxe Room from July 1 to August 31
• All Inclusive of Meals and Snacks, Domestic Alcoholic and Non-Alcoholic Beverages, Non-Motorized Water Sports, Taxes, and Service Fees
• 20% Off Spa Services
• Combine Unlimited Vouchers for an Extended Stay
The Destination
Graced with glamorous lagoons and glitzy nightlife, it's no wonder that Playa del Carmen—"Playa" to those on a first-name basis—is considered the gem of the Yucatan. Her white-hot beaches and Mayan ruins of Tulum lure visitors from all over, and that's just during the day. After hours, get the skinny on the best dance floors and local hangouts. Let's put it this way: Even people from Cozumel come to party in Playa. This beachfront city on the Caribbean Sea dazzles with a mix of Old World sites and New World attitude. She's a real stunner.
The Digs
While The Reef Playacar Beach Resort & Spa is located just minutes from the shops on 5th Avenue—Playa's main promenade—you won't find much need to leave this scenic haven. Your all-inclusive stay features three meals a day at almost any of the resort's restaurants and bars, and your air-conditioned Deluxe Room comes complete with a television, king-size bed or two doubles, and a fridge that's stocked with ice-cold beer and soft drinks upon your arrival. Just outside your door awaits a host of amenities: Float lazily in one of two swimming pools; take dance lessons with your date; or set off on a bicycling, paddleboarding, or kayaking adventure.
The Diversions
• Spa at The Reef Playacar
• Mayan Ruins of Tulum
• The Jungle Place
• Cenote Chaak Tun
PAID VALUE EXPIRES ON February 27, 2020
PROMOTIONAL VALUE EXPIRES ON December 20, 2013
the fine print
- Vouchers may be combined to extend stay
- The promotional value is valid only for date range purchased and may not be exchanged or redeemed for any other dates
- Reservations required and subject to availability; not valid toward existing or room block reservations
- Nights must be spent consecutively; all inclusions must be redeemed during one stay
- Voucher valid for 2 guests; maximum occupancy per room is 3 adults or 2 adults and 2 children, for pricing for additional persons, please contact the hotel directly
- Merchant cancellation/rescheduling policy and fees apply once booking is made; voucher subject to forfeiture
- Children 0-12 years old are free of charge if traveling May-June or September-December; If traveling July-August, children who are 0-3 years are free of charge and children 4-12 years old are $33/night/kid; children must accompany two paying adults
- Blackout dates include November 27–30
- Airfare not included
- Vouchers include All Inclusive of Meals and Snacks, Domestic Alcoholic and Non-Alcoholic Beverages, Non-Motorized Water Sports, Taxes, and Service Fees and 20% Off Spa Services
- Other conditions apply


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The sequel to the most popular Playstation Move title is back! Sports Champions 2 is coming, and will feature all-new sports such as skiing, tennis, boxing, golf, bowling, and updated archery!
Available Now
SCE San Diego Studio
E (Everyone)
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Posted on Feb 3rd 2015 3:30PM
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