By joining a PDA Task Force, you will contribute to the development or revision of highly-valued industry guidance or the preparation of PDA comments on regulatory issues of a global nature, while collaborating with a team of subject-matter experts from industry, academia and/or government agencies.
Highly-Valued Industry Guidance: PDA Technical Reports or Technical Bulletins
PDA Technical Reports and Bulletins are unique PDA products that offer expert guidance, best practices, and opinions on variety of important scientific and regulatory topics pertaining to pharmaceutical and biopharmaceutical production. Each document is vetted through the PDA peer review process-including review and approval by PDA's Science Advisory Board and/or Biotechnology Advisory Board and Regulatory Affairs and Quality Advisory Board and the PDA Board of Directors-before they are published.
Comments on Proposed Regulations and Guidance
PDA develops comments on proposed new initiatives advanced by global regulatory agencies to help ensure that new regulations and regulatory guidance have a strong science base. PDA comments are reviewed by the Regulatory Affairs and Quality Advisory Board and the PDA Board of Directors before they are submitted to the pertinent Regulatory Authority. These comments are reviewed and evaluated by these Authorities as they finalize new regulations and guidance.
For more information about the PDA Science Advisory Board, contact firstname.lastname@example.org.
Elastomeric Closures and Seals Defects
Task Force Leader: Suzanne Seeley, Merck & Co. Inc.
Technical Report No. 30 (Revision): Parametric Release of Pharmaceutical and Medical Device Products Terminally Sterilized by Moist Heat
Task Force Leader: Michael Sadowski, Baxter Healthcare Corporation
Technical Report No. 43 (Revision): Identification and Classification of Nonconformances in Ampoules, Syringes and Injection Devices for Pharmaceutical Manufacturers
Task Force Leaders: Nicholas DeBello, Wheaton Industries and Dr. Michael Eakins, Eakins and Associates
TBP (2, 4, 6-tribromophenal) Fungicidal and/or Flame Retardant Treatment on Lumber Products Task Force
Task Force Leader: Anil D. Sawant, Ph.D.
Recommended Practices for Manual Aseptic Processes
Task Force Leader: Carol Lampe, J.M Hansen & Associates, Inc.
The Manufacture of Sterile Pharmaceuticals and Liquid Medical Devices Using Blow/Fill/Seal Technology
Task Force Leader: Ken Muhvich, Ph.D., Micro-Reliance, LLC
Fundamentals of Cleaning and Disinfection Programs
Task Force Leader: Art Vellutato, Jr., Veltek Associates, Inc.
Technical Report No. 3: Validation of Dry Heat Processes Used for Sterilization and Depyrogenation
Task Force Leader: Deborah Havlik, Hospira, Inc.
Technical Report No. 13: Fundamentals of an Environmental Monitoring Program
Task Force Leaders: Jeanne E. Moldenhauer, Ph.D., Excellent Pharma Consulting
Technical Report No. 33: Evaluation, Validation and Implementation of New Microbiological Testing Methods
Task Force Leader: Michael J. Miller, Ph.D., Microbiology Consultants, LLC.