Archive from Past Meetings

• Inspection Trends
  May 8, 2013 by Janet Bowen, Compliance and Regulatory Services
• Enforcement Trends
  May 8, 2013 by Anthony Warchut, PAREXEL International
• How Excipient GMP Certification Enhances Patient Safety
  March 13, 2013 by Dr. Irwin B. Silverstein, IPEA
• Pharmaceutical Supplier Quality for the 21st Century
  March 13, 2013 by Helena CHampion, MS, MBA, Drug Quality Assurance, LLC
• Fast Track Lyophilization Development for Early Phase Programs
  January 9, 2013 by Mark Staples, PhD, Cusp Pharmatech Consulting LLC
• Current Lyophilization Initiatives: Integrating Good Science and Regulatory Perspectives
  January 9, 2013 by Edward Trappler, Lyophilization Technology, Inc.
• Risk Management Applications
  November 14, 2012 by Richard Smalley, Aptuit
• Enhancing Regulators’ Confidence in your Quality Risk Management Work Products
  November 14, 2012 by Stephen Reich, Pfizer Andover
• Securing the Online Supply Chain
  May 9, 2012 by Tara Steketee, OpSec Security, Inc.
• Natural Stable-Isotopic Records of Pharmaceutical Compounds: Anticounterfeiting and Process Patent Protection
  May 9, 2012 by John Jasper, Nature's Fingerprint Authentication / MIT LLC
• Challenges of Implementation of FDA Guideline on Process Validation
  March 14, 2012 by Chris Ames, Genzyme
• FDA Process Validation Guidance & the PDA Process Validation Interest Group
  March 14, 2012 by Hal Baseman, ValSource LLC
• PCMO Process Validation and Verification: A Life-Cycle Approach
  March 14, 2012 by Peter Levy, PL Consulting, LLC
• Introduction to eStability
  January 11, 2012 by Catherine Hosage Norman, PhD, RAC
• Stability of Parenteral Drug Products
  January 11, 2012 by Kenneth C. Waterman, PhD, FreeThink Technologies, Inc.
• Support Your Local Stabilitarian
  January 11, 2012 by John O'Neill, Boston Scientific
• VHP as a Utility
  November 9, 2011 by John Klostermyer, Steris Corporation
• Chlorine Dioxide Gas, Effective and Safe for Isolator/Room/Facility Decontamination and for Tank/Pipe Sterilization
  November 9, 2011 by Mark Czarneski, ClorDiSys
• Decontamination of Classified Environments
  November 9, 2011 by James Agalloco, Agalloco & Associates
• Development and Validation of a Potency Assay for a Recombinant Influenza Vaccine
  September 15, 2011 by Clifton McPherson, Protein Sciences Corporation
• Analytical Method Replacements - Regulatory-Approved Strategies and Case Studies
  September 15, 2011 by Stephan O. Krause, Ph.D., MedImmune
• Mapping Out the Validation Process - PDA 2011 Technical Report Overview
  September 15, 2011 by Stephan O. Krause, Ph.D., MedImmune
• PDA Technical Report 48: Moist Heat Sterilizer Systems
  May 11, 2011 by Matt Hofacre, STERIS-Project Management
• Hot Topics in the Visual Inspection of Injectable Products
  March 9, 2011 by John Shabushnig Ph.D., Pfizer Global Quality Operations
• Application of Phase-Appropriate CGMP and Quality Systems to the Development of Protein Bulk Drug Substance (or API)
  January 19, 2011, by Amnon Eylath, Director Quality, ARIAD Pharmaceuticals (919 KB)
• FDA Inspections, Post Inspection Responses and District Office Interaction
  November 10, 2010, by Amber Wardwell, Compliance Officer U.S. FDA New England District (51 KB)
• Train the Trainer
  September 8, 2010, by Linda Hook-Dinnocenzo, Vertex Pharmaceuticals Inc. (4.45 MB)
• Because “Read & Understood” Isn’t Good Enough
  September 8, 2010, by Joanna Gallant, Genzyme Corporation (2.30 MB)
• USP Activities Impacting Sterilization & Sterility Assurance
  January 2010, by James Agalloco, Agalloco & Associates (1,721 KB)
• Environmental Monitoring: A New Look at an Old Topic
  September 2009, by Jeanne Moldenhauer, Excellent Pharma Consulting (335 KB)
• Test Method for Indirect Measurement of Elastomeric Closure Compression Using an Automated Residual Seal Force Tester
  March 2009, by Roger Asselta (6.59 MB)
• Non-Destructive Container Closure Integrity Testing
  March 2009, by Heinz Wolf (6.24 MB)
• A Survey of Industry Practice for the Visual Inspection of Injectable Products (Preliminary Report)
  January 2009, by Ronald L. Leversee & John G. Shabushnig, Ph.D. (839 KB)
• Technology Update, Automated Inspections
  January 2009, by Michael W. de la Montaigne (2.72 MB)
• HOT TOPICS in the Visual Inspection of Injectable Products
  January 2009, by John G. Shabushnig, PhD (1.52 MB)
• PDA Biopharmaceutical Cleaning Validation Task Force: TR29, Initiating Good Cleaning Practices
  November 2008, by Richard Jushchyshyn, Principal, Hyde Engineering + Consulting, Inc. (42 KB)
• Maintaining Good Cleaning Practices
  November 2008, by Kathleen Kendrick, Validation Technology Manager (587 KB)
• Application of Track & Trace Technologies to Containers
  September 2008, by Michael N. Eakins, Ph.D., Principal Consultant, Eakins & Associates (560 KB)
• Environmental monitoring using a rapid non-destructive automated compendial method
  March 2008, by Andrew Sage, Principle Scientist Rapid Micro Biosystems (4.85 MB)
• Decon 2.0: Emerging Decontamination Technologies
  March 2008, by Peter Harris, Director of Operations B & V Testing, INC. (1.21 MB)
• MassBioLogics Tour Presentation
  March 2008 (1.48 MB)
• USP Guidances on Environmental Control Including related USP, FDA, EMEA & PDA Activities
  March 2008, James Agalloco (893 KB)
• Steam Sterilization and the 2007 Revision of PDA Technical Report 1
  November 2007, by Don Drew and Mike Fingers (1.39 MB)
• TR40 Sterilizing Filtration of Gases: A comparison with TR26 Sterilizing Filtration of Liquids
  June 2007, by Leesa McBurnie, Sr. Microbiologist Meissner Filtration Products, Inc. (247 KB)
• The story behind the story ! What the PDA Technical Report 39 is all about
  April 2007, by Sarvang Mishra, Senior Engineer, Wyeth (1.23 MB)
• Global Validation Requirements: The Principles of ICH, FDA, USP, Ph. Eur., JP
  February 2007, by Susan Schniepp, Quality Manager, Hospira, Inc. (1.36 MB)
• Multi-Product Biopharmaceutical Manufacturing Facilities
  November 2006, by E Hoglund (179 KB)
• Selection of a Contract Aseptic Fill/Finish Manufacturer
  January 2006, by John Dobiecki (164 KB)
• Responding to a Form 483 or Warning Letter
  May 2006, by Mark Lookabaugh (4.39 MB)
• cGMP Pitfalls in the QC Laboratory-Preparing the QC Laboratory and Staff for an FDA Inspection
  May 2006, by Michelle Sceppa (53 KB)
• FDA's High Risk Drug & Systematic Approach to Inspections
  May 2006, by Stephen Souza. (100 KB)
• Identification of Microorganisms Using Comparative DNA Sequencing
  February 2006, by Michael Waddington, Accugenix, Inc. (869 KB)
• The Extra Work that Goes into Building a Manufacturing Facility When it is FDA-Regulated
  April 2005, by Jorge Ferreira, Director of Aseptic Processing and Fill/Finish Technologies for Washington Group International (389 KB)
• An Ongoing Program to Assess Key Quality Elements at Genzyme
  April 2005, by Todd Snell, Associate Director of Corporate Quality for Genzyme (431 KB)
• Strategies for Monitoring and Troubleshooting Biopharmaceutical Operations
  April 2005, by Jack Prior, Associate Director of Technical Services for Genzyme. (1.26 MB)
• Visual Inspection of Injectable Products: More Than Just Sorting Good from Bad
  February 2005, by John G. Shabushnig, PhD, Senior Manager, Pfizer Global Quality Technical Services (1.54 MB)
• The Harmonized PAT Solution: Application of Risk-Based Tools & Process Analytical Technology Strategies in Pharmaceutical Product Manufacture
  December 2004, by Jeffrey A. Priem, Principal Consultant, Barnett International (PAREXEL Consulting)" (773 KB)
• PAT & Risk-Based Initiatives: Doing the Business [a European Perspective]
  December 2004, by Cliff Campbell, CC&A Ltd. (162 KB)
• Development and Commercialization of Combination Products, The Commercialization of an Iontophoretic Drug Delivery System
  October 2004, by George M. Baskinger, Associate Director Regulatory Affairs, Vyteris (196 KB)
• Development and Commercialization of Combination Products, A Drug-Eluting Stent Case Study: TAXUS™ Express2™ - From Development to Approval
  October 2004, by Kathleen M. Miller, Program Manager Drug Delivery, Boston Scientific (4.15 MB)
• Development and Commercialization of Combination Products, Update, Regulatory Considerations in Approval of Combination Products
  October 2004, by Mark Kramer, Director Office of Combination Products, FDA" (175 KB)
• Sterile packaging of liquidpharmaceuticals - Using rommelag bottelpack blow-fill-seal machines
  May 2004, by Mohammad Sadeghi, V.P. R&D Holopack International Corp. (2.9 MB)
• PDA Technical Report No. 26 “Sterilizing Filtration of Liquids”
  June 2007, by Jerry Martin, Sr. Vice President, Scientific Affairs Pall Life Sciences (519 KB)
• Corrective and Preventive Actions — A Five Step Approach
  February 2004, Tonya White-Salters, AVECIA (213 KB)
• The Biogen Idec Approach to Managing Corrective and Preventive Action
  February 2004, by Michael J Cross, BIOGEN IDEC (278 KB)
• Disinfectant Regulation, Technologies, Sterility and Validtion
  December 2003, by Jim Polarine, MA, STERIS (955 KB)
• Approaching Compliance with 21 CFR Part 11
  September 2003, by Alexander Buck, FORMATECH (148 KB)
• The Evolution of a New Disposable Filling Technology for Sterile Pharmaceuticals
  May 2004, by Jim Furey, Product Manager Millipore Corporation (1,019 KB)