July/August PDA Letter

ray shaw pdf

Fri, 23 Jul 2010 16:51:43 GMT

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June 2010

Fri, 23 Jul 2010 09:56:35 GMT

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June Cover

Fri, 23 Jul 2010 11:48:21 GMT

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The Status of Current Good Distribution Practice (GDP) Regulations in Israel

Tue, 01 Jun 2010 10:08:18 GMT

Current Israeli legislation in the area of storage and distribution of medicinal products has typically been legislated in a somewhat piece-meal manner. Over the years, Good Distribution Practice regulations have been addressed both directly and indirectly in various contexts. Moving forward, however, big changes are anticipated with the completion of the formal GDP legislation in Israel at the end of 2010.

Trends and Challenges Addressed at Parenteral Conference

Tue, 01 Jun 2010 10:36:26 GMT

It is predicted that in coming years parenteral products will outpace all other dosage forms.

Frederick Carleton Passed Away, May 20

Tue, 01 Jun 2010 09:49:29 GMT

Frederick J. Carleton, PDA Honorary Member, past Officer, Director, and Executive Director, passed away on May 20 in Boynton Beach, Florida.

Industry Faces Challenges in Sterile Drug Manufacturing, Aseptic Processing

Fri, 23 Jul 2010 10:21:40 GMT

PDA Pharmaceutical companies continue to have issues with GMP requirements for aseptic processing, and the U.S. FDA, under its policy of swift, aggressive and effective enforcement, is employing its full range of enforcement tools to improve compliance in this area.

Top Ten Myths of Container Closure Integrity Testing

Fri, 23 Jul 2010 11:42:24 GMT

Three decades ago, testing a container closure system for integrity meant performing a product sterility test. As recently as ten years ago, container closure integrity testing (CCIT) meant microbial challenge tests, or in more progressive circles, dye ingress tests. Advances in package leak testing technology and shared research studies present a new opportunity to redefine CCIT.

European article - Figure 2

Wed, 02 Jun 2010 09:00:52 GMT

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European article - Figure 1

Wed, 02 Jun 2010 08:59:43 GMT

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Maintain Quality in Midst of a Merger at PDA/FDA Session

Fri, 23 Jul 2010 10:13:48 GMT

The date for the 2010 PDA/FDA Joint Regulatory Conference is drawing near. Scheduled for September 13-15 in Washington D.C., this year's conference theme focuses on how companies can maintain quality standards while dealing with mergers, acquisitions and new merging regulations.

May 2010

Tue, 01 Jun 2010 10:49:11 GMT

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may cover

Tue, 01 Jun 2010 11:09:42 GMT

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Learning About Drug Product Distribution

Thu, 29 Apr 2010 12:31:09 GMT

Being at PDA for a little more than two years has given me multiple opportunities to learn about the challenges in production and delivery of drug products. But, when I was told there was another occasion to discover even more about the complexities of drug product transport and storage, I jumped at the chance and signed up for the PDA New England (NEPDA) Chapter event.

Missed the TRI Courses at Annual? Sign up for In-house Training

Thu, 29 Apr 2010 12:44:22 GMT

This year at the Annual Meeting, the Training and Research Institute was at it again with crowd-pleasing activities at the booth and in-depth training opportunities following the conference.

Mission Excellence: Over 60 Talks at PDA Annual Meeting on Improving Manufacturing

Thu, 29 Apr 2010 11:32:16 GMT

The success some firms are having with efforts to modernize manufacturing and control processes was manifest at the 2010 PDA Annual Meeting. Talks covered the gambit of innovations and solutions from process analytical controls to quality by design programs.

Read the Full July/August Issue (Members Only)

Fri, 23 Jul 2010 15:47:49 GMT

PDA remembers Raymond Shaw in the July/August issue of the PDA Letter. An article about industry's recent challenges with aseptic processing and sterile drug manufacturing is featured. In "Hailey's Comments" resident Korean Regulator Hailey Park discusses the drug registration process in Korea. Articles about the upcoming 2010 PDA/FDA Joint Regulatory Meeting appear throughout the issue-look for the PDA/FDA logo. Be sure to check out photos from the cold chain and vaccines conferences in the "Faces and Places."

April 2010

Thu, 29 Apr 2010 15:30:25 GMT

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cover

Fri, 30 Apr 2010 09:37:01 GMT

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An Interview with TRI Instructor Barry Friedman

Thu, 25 Mar 2010 16:09:26 GMT

The following is a question and answer between one of the TRI staff, Stephanie Ko and TRI instructor Barry Friedman about Barry's outstanding teaching history and his ability to keep students engaged in and out of the classroom.

Container Closure Integrity Testing Methodologies

Thu, 25 Mar 2010 15:38:01 GMT

Container closure integrity is defined as the ability and quality of a container closure system to provide protection and maintain efficacy and sterility during the shelf life of a sterile drug product.

Pharma's Reaction to Health Care Bill Mixed

Fri, 26 Mar 2010 07:08:02 GMT

On Monday, March 22, it appeared that comprehensive reform to the way Americans receive health care will become a reality following the U.S. House of Representatives approval of reconciliation legislation that incorporates much of a bill approved by the U.S. Senate on Christmas Eve. The White House intends to sign the bill on Tuesday, March 23, and the Senate must approve minor changes.

June Cover

Tue, 16 Jun 2009 10:13:26 GMT

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Podcasts

Wed, 04 Feb 2009 15:41:00 GMT

Web-exclusive content for the PDA Letter.

About PDA Letter

Tue, 09 Sep 2008 10:57:20 GMT

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2009 PDA Letter Insertion Order Form

Thu, 25 Sep 2008 13:07:22 GMT

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Authors Wanted

Mon, 11 Aug 2008 16:02:06 GMT

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Members Only Archives

Tue, 28 Oct 2008 13:29:41 GMT

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PDA Interest Groups & Leaders

Thu, 25 Sep 2008 11:21:00 GMT

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Recent Sci-Tech Discussions

Thu, 25 Sep 2008 05:46:34 GMT

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Regulatory Briefs

Thu, 25 Sep 2008 11:25:10 GMT

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Quality and Regulatory Snapshot

Thu, 25 Sep 2008 05:44:40 GMT

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Science and Technology Snapshot

Thu, 25 Sep 2008 05:43:26 GMT

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May 2008

Wed, 10 Sep 2008 07:48:24 GMT

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May Cover Image

Mon, 01 Dec 2008 08:18:16 GMT

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Industry Comes Clean at Workshop (PDF)

Mon, 08 Sep 2008 15:33:06 GMT

PDA held a second edition of its cleaning and disinfection workshop in Budapest,Hungary on February 18-19,preceding the 2008 PDA/EMEA Joint Conference.The workshop received much attention, especially from the 11 European Inspectorates present.The interaction between the inspectors and the other delegates, mostly from European pharmaceutical industry,was stimulating.

Inspector Highlights Quality Management Deficiencies (PDF)

Mon, 08 Sep 2008 15:32:59 GMT

At the 2008 PDA/EMEA Joint Conference,Tor Gråberg,Chief Pharmaceutical Inspector of the Swedish Medical Products Agency, gave a presentation entitled "Inspections Update: Major Observations."

Three EMEA Speakers Confirmed: QBD for Tangible Benefits Conference (PDF)

Mon, 08 Sep 2008 15:32:53 GMT

Quality by Design(QbD)is becoming a very often used, but not so well understood term. Therefore, after its very successful Workshop in 2007, PDA is organizing a conference on this topic to be held in Frankfurt, Germany, October 7-8. The conference will strive to demonstrate the tangible benefits of QbD, if applied correctly, with presentations illustrating practical examples of such applications. The committee has titled the conference,Quality by Design for Tangible Benefits:Charting the Path from Pharmaceutical Development to Regulatory Flexibility.

2009 PDA Annual Meeting Preview

Wed, 11 Mar 2009 08:45:17 GMT

Special PDA Letter preview of the 2009 PDA Annual Meeting.

15 IGs, 5 Task Forces, SAB, BioAB to meet during 2009 Annual Meeting

Wed, 11 Mar 2009 13:39:32 GMT

PDA members and volunteers will dedicate some of their time at the 2009 Annual Meeting conducting the business of the Association.

2009 PDA Annual Meeting Homepage

Wed, 11 Mar 2009 13:37:17 GMT

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Register Online

Wed, 11 Mar 2009 13:36:30 GMT

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2009 PDA Annual Meeting Agenda

Wed, 11 Mar 2009 13:35:41 GMT

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Registration Form

Wed, 26 Nov 2008 15:45:22 GMT

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Preview a TRI Course at PDA's Annual Meeting

Wed, 11 Mar 2009 11:40:59 GMT

I'm sure many of you head to the movie theaters at least a few minutes before showtime to purchase your snacks and grab a good seat. But if you're like me, that's not the only reason you get there early--you're there to see the previews! You actually get to see whether a movie is worth two hours of your time by watching, rather than by guessing how you might like it from just reading a description in the paper, on the internet or through an e-mail. Well, now you have an opportunity to take the same sneak peak into the training courses offered by PDA's Training and Research Institute (TRI).

2009 PDA Annual Meeting Networking Events: Come Join the Fun!

Wed, 11 Mar 2009 11:20:58 GMT

Make your conference experience a well-rounded one by taking advantage of networking activities that bring you face-to-face with your peers, as well as industry and regulatory leaders. Share ideas, exchange information, make valuable contacts to take home with you--and have fun while doing it!

Microchips at Meeting, Poker Chips at Casino!

Wed, 11 Mar 2009 10:33:12 GMT

In April 2009, the PDA Annual Meeting will be held at the Redrock Resort, Casino and Spa in Las Vegas. The program planning committee is very busy putting the finishing touches the conference and events which we have planned for you. This years PDA Annual Meeting will take place April 20-24. We believe this meeting has the perfect blend of education, excellence in science and yes, fun! This is PDA's "flagship" event and continues to be considered as the year's most valuable networking opportunity. We look forward to seeing you there.

Annual Meeting Events for New Members, Volunteers

Wed, 11 Mar 2009 10:21:27 GMT

Please RSVP by March 19. For more information and to RSVP, please contact Hassana Howe at +1 (301) 656-5900 ext. 119 or howe@pda.org. You must be a full conference attendee to attend this event. RSVP is required.

Exhibitors at the 2009 PDA Annual Meeting

Wed, 11 Mar 2009 10:14:45 GMT

Exhibitors at the 2009 PDA Annual Meeting (as of February 27) include:

Bio/Pharma Issues Examined by European Speakers at PDA's Annual Meeting

Wed, 11 Mar 2009 09:53:09 GMT

At the 2009 PDA Annual Meeting industry members from the United States and Europe are coming together to explore some of the most influential factors impacting the current state and future development of the pharmaceutical and biopharmaceutical industry.