PDA Letter
Home / PDA Letter / Quality and Regulatory

Quality and Regulatory

News Brief: FDA’s Reorganization Plan Comes into Focus at PDA/FDA Joint Regulatory Conference

Walter Morris, PDA

News Brief: Navigating Regulatory Uncertainty

Justin Johnson, PDA

Validating NGS-Based Assays In-House for Virus Safety Assessment

Christoph Bredack, PhD, Genedata

Process Hold Times: What is it and Why is it Important?

Robert Dream, MS, Nivagen Pharmaceuticals and Bruce Loxley, GSK

New Training Course – Manage your Aseptic Filling Line

Julian Petersen, groninger & co. gmbh

PDA Hosts Industry Focused Roundtable on Speeding Innovation through Global Regulatory Convergence

Glenn E. Wright, PDA President and CEO

Navigating the CDMO-Sponsor Partnership

Morten Munk, FUJIFILM Diosynth Biotechnologies , Virginia Boldt, Accenture , and Andrew Chang, PhD, PhD, Novo Nordisk

An Alternative and Sustainable BET Designed for Patient Safety

Parampal Deol, PhD, Charles River Laboratories

Industry Expert Discusses the Value of the PDA/FDA Joint Regulatory Conference 2024

PDA

A Holistic Approach to CCI is a Deterministic Approach

Oliver Stauffer, PTI

Pathway to a Contamination Control Strategy

Londa Ritchey and Patrick Nieuwenhuizen, PharmaLex

FDA/CDER Readying Draft Guidance on AI to Support Regulatory Decision-Making

Justin Johnson and Walter Morris, PDA

Meeting the ATMP Moment with Robotics and Automation

Josh Russell, AST

A Path Towards Improved Training Outcomes and Better GxP Compliance

Kent Malmros, Veeva Training Strategy and Iain Searle, Veeva Training Strategy

Aseptic Transfers to Grade A

Julian Petersen, groninger & co. gmbh and Richard Denk, SKAN AG

Building a Quality Culture Using Quality Systems

Ron Branning, GXP Quality Systems, LLC, GXP Quality Systems, LLC

The Annex 1 2022 Revision: A Success Story, Still to be Written

Hal Baseman, ValSource, Inc. and Gabriele Gori, MA, Independent Consultant

The Key to Compliance with Annex 1 and Risk Based Regulations

Noelle Clifford, PharmaLex, PharmaLex

A View on the Revised Annex 1

Antonio Burazer, Takeda , Alexander Artau, Sanofi , Elisabeth Wagner,  CSL Behring , and Joseph Straub, Merck

Elevating Sterile Manufacturing

Simone Biel, PhD, Merck, Merck

A Comprehensive Review of Regulatory Intelligence: Exploring Tools and Program Maturities

Jason Kerr, Moderna , Katie Bevard, Eli Lilly , and Maria Jacobs, PhD, Pfizer, Inc.

A Comprehensive Review of Regulatory Intelligence and Its Framework

Jason Kerr, Moderna , Katie Bevard, Eli Lilly , and Maria Jacobs, PhD, Pfizer, Inc.

Biosafety Guidelines for Handling Microorganisms in Microbiology Laboratories

Tony Cundell, PhD, Microbiological Consulting, LLC

Next Steps in ATMPs and Beyond

Renske ten Ham, PhD, UMC Utrecht and Richard Denk, SKAN AG

Microbial Control During Low-Risk Aseptic Processing

PDA Staff Author: David Jaworski, MBA

Advanced Nucleic Acid Testing Methods Rise to the Challenge

Manjula Aysola , Danielle DiTirro , Pamela Hamill , and Alison Armstrong, MIlliporeSigma

Seven Key Takeaways from PDA’s Viral Safety for ATMPs Workshop and Virus Conference Events

Alison Armstrong, PhD, Merck KGaA, Andy Bailey, ViruSure, Sean O’ Donnell, PhD, Eli Lily, and Sebastian Teitz, Biopharma Excellence

Challenges of Analytical Method Validation for ATMPs

Patrick Nieuwenhuizen and Christopher Rogers, PharmaLex

Reducing Human Error for Manual Visual Inspection

Vanessa Vasadi Figueroa, QxP and VVF Science, and Robert Ferer, QxP

Continuing the Conversation for Better ATMP Development

Virginia Boldt, Accenture, Stephan Krause, PhD, Bristol Myers, and Friedrich von Wintzingerode, PhD, Roche-Genentech