June Letter
2009 PDA/FDA Joint Regulatory Conference
PDA Summer Book Sale
PDA-FDA Course Series
2010 PDA Annual Meeting
PDA Web Seminars-Anywhere Learning
June Letter
2009 PDA/FDA Joint Regulatory Conference
PDA Summer
PDA-FDA Courses
2010 Annual Meeting
PDA Web Seminars-Anywhere Learning

What's New!

Recommended Reading

  • 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. 
Biological Indicators for Sterilization Processes
Editors: Margarita Gomez, PhD and Jeanne Moldenhauer