Science and Technology

EMEA & EU Authorities Provide Public Info on GMP Status

Mon, 10 Aug 2009 15:59:55 GMT

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Audit Guidance Advisory Board (AGAB)

Tue, 23 Jun 2009 09:02:56 GMT

The PDA Audit Guidance Advisory Board (AGAB) provides governance and oversight to the Audit Resource Center (ARC) as well as maintains the supplier audit process; as published in PDA Technical Report No. 32 "Auditing of Suppliers Providing Computer Products and Services for Regulated Pharmaceutical Operations" (Revised 2004).

Paradigm Change in Manufacturing Operations (PCMO)*

Fri, 05 Jun 2009 09:34:34 GMT

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PCMO Related Articles

Thu, 25 Jun 2009 13:07:40 GMT

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PCMO Dossier

Fri, 05 Jun 2009 11:19:10 GMT

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PCMO Deliverables

Fri, 05 Jun 2009 10:58:39 GMT

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PCMO History

Fri, 05 Jun 2009 10:52:19 GMT

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Why is PDA driving PCMO?

Fri, 05 Jun 2009 10:50:19 GMT

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List of Topics Covered by PCMO

Fri, 05 Jun 2009 10:41:30 GMT

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Call for volunteers: Combination Products Task Force and Sub-Committees

Fri, 05 Dec 2008 14:01:09 GMT

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Science Advisory Board (SAB)

Mon, 11 Aug 2008 15:15:49 GMT

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PDA Science Advisory Board Members

Thu, 18 Feb 2010 09:30:44 GMT

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Biotechnology Advisory Board ( BioAB)

Mon, 11 Aug 2008 15:15:56 GMT

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PDA Biotechnology Advisory Board Members

Wed, 24 Feb 2010 10:20:33 GMT

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PDA Biotechnology Advisory Board Update, Spring 2007

Thu, 28 Aug 2008 10:19:16 GMT

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Technical Reports

Fri, 09 Jan 2009 12:50:34 GMT

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PDA Journal of Science and Technology

Tue, 27 Jan 2009 15:09:43 GMT

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Student Programs

Mon, 11 Aug 2008 15:19:54 GMT

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2009 PDA Annual Meeting

Mon, 15 Sep 2008 22:13:05 GMT

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PDA Student and Academic Membership

Mon, 11 Aug 2008 15:50:53 GMT

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Interest Groups

Mon, 11 Aug 2008 15:17:40 GMT

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Join An Interest Group

Mon, 29 Sep 2008 20:37:11 GMT

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Modern IT to Breathe Life into Interest Groups

Mon, 08 Sep 2008 15:59:51 GMT

PDA has had interest groups for a number of years. The intent of the interest groups was to create an opportunity for PDA members with an interest in a particular topic to come together to explore it, ask questions and get answers and perhaps develop some type of deliverable, such as a technical report. The original plan called for new interest groups to form as the need arose, and to close interest groups as the topic became exhausted.

Join an Interest Group

Tue, 05 Aug 2008 13:23:09 GMT

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PDA Technical Reports

Mon, 15 Sep 2008 21:29:45 GMT

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List of Interest Groups

Thu, 04 Sep 2008 13:52:42 GMT

Some Interest Groups content is restricted to PDA Members Only.

About PDA

Mon, 15 Sep 2008 21:14:14 GMT

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Interest Group Report

Mon, 08 Sep 2008 15:39:00 GMT

The following are reports from two interest group meetings at the 2008 PDA Annual Meeting.

PDA Volunteer Form

Tue, 05 Aug 2008 11:35:46 GMT

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PDA Interest Groups

Mon, 11 Aug 2008 15:48:14 GMT

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Task Forces

Mon, 11 Aug 2008 15:17:46 GMT

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Sci-tech Discussion Forum

Wed, 27 Aug 2008 13:26:13 GMT

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Audit Resource Center

Mon, 11 Aug 2008 15:16:46 GMT

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Science and Technology News

Mon, 11 Aug 2008 15:16:53 GMT

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In Print: QbD for Cleaning Validation

Tue, 23 Feb 2010 10:55:11 GMT

March 2010 We have all heard dreadful stories about delays to submissions, new product introductions and product releases because of failed cleaning validation. These types of costly delays can be prevented if we enter into validation after we are confident that the cleaning cycle is robust and validatable. However, far more than we would like to admit, we have witnessed or heard of events that demonstrate that this has not been the mindset or culture. Many firms have adopted an overkill approach, where they have developed extreme cycles to assure success. These cycles consume excess energy, cleaning agents, and water; increase equipment turnaround times; and produce more waste.

Technical Report Watch

Tue, 23 Feb 2010 08:25:37 GMT

March 2010 See where certain technical reports are within the publishing process.

The Challenges of Success - Looking forward to 2010 PDA SciTech Activities

Tue, 23 Feb 2010 08:18:21 GMT

March 2010 Each successive year, I have had the pleasure to report to you that PDA's SciTech program has been on an upward trend, as measured by the number of approved Task Forces and participants. In 2010, I expect more teams than ever before in my tenure to complete their goals and publish their deliverables. At the end of February, we will have already published two technical reports, Last Mile: Gidance for Good Distribtution Practices for Pharmaceutical Products to the End User (TR-46) and Preparation of Virus Spikes Used for Virus Clearance Studies (TR 47).

Journal Preview: Bio's CEO writes on Biotech Public Policy

Tue, 26 Jan 2010 13:00:39 GMT

February 2010 Volume 64, No. 1 (January/February) of the PDA Journal of Pharmaceutical Science and Technology is now available online. This issue has a guest editorial from James Greenwood, President and CEO, Biotechnology Industry Organization, on the public policy that is needed to advance biotechnology innovation. In addition, results from an FDA-sponsored study on the risks of changing sterile drug manufacturing sites are published.

Technical Report Watch

Tue, 26 Jan 2010 12:54:49 GMT

February 2010 Over the years, PDA expert task forces have developed several technical reports on various aspects of filtration. Now you can own all five of them in one easy-to-use hardbound volume.

IG Briefing: 13 PDA Interest Group Sessions

Tue, 26 Jan 2010 12:50:18 GMT

February 2010 The following is the schedule for the 13 interest group sessions that will occur on Monday, March 15 and Tuesday, March 16 at PDA's Annual Meeting.

Task Force Corner: Size, Workload Distinguishes PDA's Mycoplasma TF

Mon, 04 Jan 2010 13:48:02 GMT

January 2010 PDA's Mycoplasma Task Force boasts an ambitious agenda of nine articles, three technical reports and a training workshop. Task Force leader Barbara Potts outlined the group's work at PDA's 4th Annual Global Microbiology Meeting in October.

Advisory Board Watch: An Update on PDA's Three Scientific Advisory Boards

Mon, 04 Jan 2010 12:21:23 GMT

January 2010 The following article is a report on three of PDA's Advisory Boards.

2009 Archives

Mon, 04 Jan 2010 12:08:37 GMT

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2008 Archives

Fri, 09 Jan 2009 14:39:59 GMT

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Call for Authors or Reviewers

Mon, 11 Aug 2008 16:43:14 GMT

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