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Task Forces

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.

Contribute to a Highly-Valued Industry Guidance: Help Write a PDA Technical Report or Technical Bulletin
PDA Technical Bulletins and Reports 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 the PDA Board of Directors-before they are published.

Ensure the development of Science-Based Global Regulatory Requirements: Help Develop PDA 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 Committee 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.

List of Science and Technology Task Forces

Aseptic Processing for Manual Procedures
Task Force Leader: Olivia Henderson, Biogen Idec

Standard Audit Criteria Task Force
Task Force Leader: Peter Miller, Dynamic Compliance Solutions

Biological Indicators for Sporicidial Gassing Processes: Production, Control and Use
Task Force Leader: Graham Steele. Albert Browne Ltd.

The Manufacture of Sterile Pharmaceuticals and Liquid Medical Devices Using Blow/Fill/Seal Technology
Task Force Leaders: Harold S. Baseman, ValSource LLP, Ken Muhvich, Ph.D., Micro-Reliance, LLC, Eric Dewhurst, Teva Runcorn and Peter Ackerman, Flexware Innovation

GMP Considerations for Manufacture of Investigational Drug Product
Task Force Leaders: Karen Ginsbury, PCI Pharmaceutical and Carina Sonnega, Biotechnology Consultant, Regulatory and Quality Affairs

Lyophilization
Task Force Leaders: Bent Palmqvis, Novo Nordisk and Palle Gregersen, Biogen Idec

Non-Sterile Environmental Monitoring
Task Force Leader: Anthony Cundell, Schering-Plough Corporation

Parametric Release of Pharmaceutical Products and Medical Devices Terminally Sterilized by Moist Heat
Task Force Leader: Mike Sadowski, Baxter Healthcare

Retest Dating on Early Clinical Trial Materials
Task Force Leader: Vince Mathews, Eli Lilly and Company, and Katherine Greene, Novartis Pharmaceuticals

Steam in Place
Task Force Leader: Kevin Trupp, Hospira

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

Analytical Methods Development for Biotechnology Products
Task Force Leaders: Nadine M. Ritter, Ph.D., Biologics Consulting Group and Melissa Smith, MJ Quality Solutions

Analytical Methods Validation for Commercial Biopharmaceutical Products
Task Force Leader: Stephan O. Krause, Favrille, Inc.

Cell Substrates
Task Force Leader: Kathryn King, Ph.D., Food and Drug Administration/CDER and Michael Wiebe, Ph.D., Quantum Consulting, LLC

Combination Products
Task Force Leader:  Michael A. Gross, Ph.D., Chimera Consulting

Fundamentals of Cleaning and Disinfection Programs
Task Force Leader:  Art Vellutato, Jr., Veltek Associates, Inc.

Cleaning Validation
Task Force Leaders: Destin LeBlanc, Cleaning Validation Technologies

Single Use Systems
Task Force Leader: Robert Repetto, Wyeth BioTec

Filtration of Liquids Using Cellulose-Based Depth Filters
Task Force Leader: George Quigley, ErtelAlsop

Investigating Microbiological Data Deviations (MDD)
Task Force Leader: Jeanne E. Moldenhauer, Ph.D.,  Excellent Pharma Consulting

Moist Heat Sterilizer Systems:  Design, Installation and Operation Qualification
Task Force Leader: Christopher J. Smalley, Ph.D., Wyeth Pharmaceuticals

Mycoplasma: Contamination and Control
Task Force Leader: Barbara J. Potts, Ph.D., Genentech

Nomenclature for Small Virus Filtration
Task Force Leader: Kurt A. Brorson, PhD, Food and Drug Administration/CDER

Phase Appropriate Application of GMPs and Quality Practices to the Development of Bioprocess API
Task Force Leader: Amnon Eylath, Eli Lilly and Company

Quality Risk Management for Aseptic Processes
Task Force Leader: Harold S. Baseman, Valsource, LLP

Reprocessing of Biopharmaceuticals
Task Force Leader: Harold Van Deinse, Baxter Healthcare Corporation

Technical Report No. 3: Validation of Dry Heat Processes Used for Sterilization and Depyrogenation
Task Force Leader: Deborah Havlik, Hospira

Technical Report No. 14: Standard Practices in Chromatography
Task Force Leader: Norbert Hentschel, Boehringer Ingelheim Pharma GmbH & Co. KG

Technical Report No. 13: Fundamentals of an Environmental Monitoring Program
Task Force Leaders: Jeanne E. Moldenhauer, Ph.D., Excellent Pharma Consulting and Victoria Galliani, Excellent Pharma Consulting

Technical Report No. 15: Industrial Perspective of Tangential Flow Filtration in Biopharmaceutical Applications
Task Force Leader: Peter F. Levy, PL Consulting

Technical Report No. 22: Process Simulation Testing for Aseptically Filled Products
Task Force Leader: Dr. James Agalloco, Agalloco & Associates

Technical Report No. 26: Sterilizing Filtration of Liquids
Task Force Leader: Paul J. Stinavage, Ph.D., Pfizer Inc.

Technical Report No. 33: Evaluation, Validation and Implementation of New Microbiological Testing Methods
Task Force Leader: Michael J. Miller, Ph.D., Microbiology Consultants, LLC

Preparation of Virus Spikes Used for Virus Clearance Studies
Task Force Leader: Hannelore Willkommen, Ph.D, RBS Consulting

 
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