Parenteral Drug Association

  

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What's New!

  • AAMI and FDA Summit on Infusion Devices
    (October 5-6, 2010, FDA Headquarters, Silver Spring, MD) PDA is pleased to be a collaborating partner with AAMI and the FDA in a special summit focusing on critical issues surrounding infusion devices. We invite you to attending this important event.
  • ICH Quality Implementation
    Brochure Now Available:
    USA: 6-8 October 2010 Washington, DC
    Japan: 25-27, October 2010 Tokyo

    Practical training on integrated implementation of Q8, Q9 and Q10 in pharmaceutical development, manufacturing, regulatory assessment, scale up to commercial operation, and GMP-inspection. This is an opportunity for open dialogue among industry and regulators on: Comprehensive training on regulatory aspects, technical development and manufacturing, case study combining Q8, Q9 and Q10 and regulatory topics related to submission expectations and GMP-inspections.


  • Free Webinar: PDA’s Paradigm Change in Manufacturing Operations (PCMO) Initiative
    October 13, 2010: The free PCMO Webinar scheduled for October 13, 2010 will provide an educational opportunity for the PDA membership to become familiar with the infrastructure of this initiative. During this Webinar, you will learn why ICH documents are of primary importance.  You will gain an increased understanding of PDA’s objectives for putting science and regulation into practice.  Existing Technical Reports will be discussed and analyzed with respect to industry needs.  Other venues will be discussed such as Topics for Life Cycle Approach, Quality Systems, Process Management, and Quality Risk Management. To RSVP and received the Webinar call-in information please contact PDA at rice@pda.org.
  • PDA/FDA Adventitious Viruses in Biologics: Detection and Mitigation Strategies Workshop Call for Pos
    (Deadline: October 15, 2010) The Program Planning Committee for this workshop is now accepting abstracts for consideration of poster presentations. The workshop will take place December 1-3, 2010 in Bethesda, Maryland. For details on suggested topics, view the Call for Posters online. Submit an abstract by October 15, 2010.
  • US FDA Guidance Helps Applicants Submit CMC Drug Substance Information in CTD Format
    A Center for Veterinary Medicine guidance providing recommendations on the chemistry, manufacturing and controls (CMC) information for drug substances that should be submitted to support original new animal drug applications and abbreviated new animal drug applications is now available.
 
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