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Quality and Regulatory

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

Aligning Global Regulatory Guidance Documents for Container Closure Integrity

Oliver Stauffer, PTI

2023 PDA Quality & Regulations Conference

Patrick Costello, AbbVie Pharmaceuticals, and Vinny Browning, Amgen (Co-Chairs)

Microbiologists and Training: A Crucial Quality Connection

Donald C. Singer, Ecolab, and Radha Tirumalai, PhD, Merck & Co., Inc.

The Difficult Task of Solving Contamination Puzzles

Paula Peacos and Kim Sobien, ValSource, Inc.

Artificial Intelligence and Machine Learning in the Early Stage of a Product Life Cycle

By Maria Batalha, Rui Almeida, Ângela Martinho and Daniel Pais, PhD, Valgenesis

Per- and Polyfluoroalkyl Substances Ban Starting 2027

Ana Kuschel, PhD, West Pharmaceutical Services

Quality Culture Post-Pandemic

Tamer Helmy, PhD

Macro Impacts from the Micro-Universe

Kurt Jaecques, GSK, and Vineeta A. Pradhan, U.S. FDA

The 2023 PDA BioManufacturing Conference Lands in Seville, Spain

Cristiana Campa, PhD, GSK, and Elisabeth Vachette, Sartorius Stedim Biotech

Maintaining Compliance with Deviation Reports: A Glimpse into the 2023 PDA Mastering Deviations Workshop

Kate Malachowski, Novavax

Making The Most of External Signals for Internal Learning and Knowledge Management

Denyse D. Baker, Eli Lilly and Company, Jackie Veivia-Panter, BioCentriq, and Janeen Skutnik-Wilkinson, Moderna, Inc.

2023 PDA Particle Control in Biopharmaceuticals

Roman Mathaes, Clear Solutions Laboratories

From Risk Assessment to Employee Training

Vinicius Tarantino, GxP-CC