The June PDA Letter is Now Available!
Coverage and photos from the 2009 PDA Annual Meeting and much more.
Confirmed Keynote Speaker
Joshua M. Sharfstein, MD FDA Principal Deputy Commissioner
PDA Summer Book Sale!
Save 10% until August 31st
2009 PDA/FDA Joint Regulatory Conference Course Series
PDA TRI is offering 10 courses immediately following the conference.
March 15-22, 2010 Orlando Florida
Examine manufacturing best practices and strategies to maximize your company’s efficiency and productivity!
Patient Care and "Last Mile" Distribution of Medicinal Products
7/9/2009, 1 p.m. - 2:30 p.m.- Earn CEUs!
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07/29/2009
:
PDA Cell Substrate Workshop
, Bethesda, Maryland
08/03/2009
:
Rapid Microbiological Methods
, Bethesda, Maryland
08/25/2009
:
Application of Disposables in Biopharmaceutics
, Bethesda, Maryland
09/14/2009
:
2009 PDA/FDA Joint Regulatory Conference
, Washington, D.C.
10/06/2009
:
Pharmaceutical Cold Chain Management
, Berlin, Germany
10/13/2009
:
PDA/EMEA Joint Conference
, Berlin, Germany
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2008 PDA Honor Awards Winners
During the 2009 PDA Annual Meeting, the following persons were recognized for their achievements and contributions to PDA and the industry.
Industry and Regulatory Experts Confirmed to Speak on Virus Testing and Facility Contamination for PDA Cell Substrate Workshop
PDA has confirmed that regulatory and industry experts will speak during Plenary Session 3: Virus Testing of the
PDA Cell Substrate Workshop
.
SIFDS/PDA Shanghai Joint Development Center Unveils Office
Officials from the Shanghai Institute of Food and Drug Safety (SIFDS), a branch of the Shanghai Municipal Food and Drug Administration (SHFDA), and PDA celebrated the grand opening of a new office for the SIFDS/PDA Joint Development Center (SHJDC).
New Date for Autoclave Operations Training: September 2-4
This combination lecture and laboratory course will offer a unique combination of interactive sessions coupled with hands-on activities to provide the attendee with intensive understanding of steam sterilizer operating principles, effective use and maintenance.
Keynote Speakers Confirmed for PDA’s 4th Annual Global Conference on Pharmaceutical Microbiology
The Parenteral Drug Association (PDA) has confirmed two keynote speakers for PDA’s 4th Annual Global Conference on Pharmaceutical Microbiology.
June PDA Letter Now Available
The June issue of the PDA Letter recaps the 2009 PDA Annual Meeting including the plenary sessions which included predictions about the future of health care and where the pharmaceutical industry is headed with respect to the use of technology. “News and Notes” reflects a busy time at PDA with articles announcing a major change to PDA member benefits, a new arrangement with the PDA Taiwan Chapter, announcement of the 2008 PDA Honor Awards winners and a preview of speakers at the PDA/EMEA Joint Regulatory Conference. Lastly, the issue also highlights how “Going Green Can Save the Green Stuff,” and how to “Keep Employees Happy During a Recession.” Make sure you take a look at the Faces and Places section for photos from the Annual Meeting.
PDA Launches Paradigm Change in Manufacturing Operations Project
Using the Parenteral Drug Association’s (PDA) membership expertise, the goal of the Paradigm Change in Manufacturing Operations (PCMO) Project is to drive the establishment of ‘best practice’ documents and /or training events in order to assist pharmaceutical manufacturers of Investigational Medicinal Products (IMPs) and commercial products in implementing the ICH guidelines on Pharmaceutical Development (ICH Q8, Q11), Quality Risk Management (ICH Q9) and Pharmaceutical Quality Systems (ICH Q10).
2009 PDA/EMEA Joint Conference Looks At Ensuring Patient Safety through Supply Chain Control and GMP
Presentations will cover legislation, guidances and GMP initiatives under the conference theme of Ensuring Patient Safety through Supply Chain Control and GMP. Three parallel tracks at the conference will address (1) Supply Chain Quality, (2) Implementation of ICH Q8-9-10, and (3) high interest issues in Manufacturing and GMP
Join FDA Principal Deputy Commissioner Joshua Sharfstein at the 2009 PDA/FDA Conference
Joshua M. Sharfstein, MD
, was appointed by President Obama to be the FDA Principal Deputy Commissioner. Sharfstein is a keynote speaker for the 2009 PDA/FDA Joint Regulatory Conference! Before his current position, Sharfstein served as Acting Commissioner for Food and Drugs from March 29-May 25, 2009. To learn more about Joshua M. Sharfstein, view his biography on the conference website, www.pda.org/pdafda2009
PDA's First Electronic Technical Report is now Available: PDA Technical Report No. 15 (Revised 2009) – Free to members until June 30, 2009
PDA Technical Report No. 15 (Revised 2009): Validation of Tangential Flow Filtration in Biopharmaceutical Applications,
updates the 1992 original version of Technical Report No. 15 in response to the substantial changes that has occurred in industry since then, including improvements to processing equipment, introduction of new technology and materials, and publication of substantial new guidance on validation.
Practical Aseptic Processing: Fill and Finish, Volume I and II
Editor: Jack Lysfjord
Biological Indicators for Sterilization Processes
Editors: Margarita Gomez, PhD and Jeanne Moldenhauer
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