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Previously Featured Articles

FDA/CDER Readying Draft Guidance on AI to Support Regulatory Decision-Making

Justin Johnson and Walter Morris, PDA

Unleashing the Power of AI

Tejesh Marsale, PCI Pharma Services

Meeting the ATMP Moment with Robotics and Automation

Josh Russell, AST

Manufacturing Capacity Expansion and Validation for Autologous Cell Therapies

Stephan Krause, PhD, Bristol Myers Squibb and Adam Boyer, Bristol Myers Squibb, Bristol Myers Squibb

Legacy Filling Lines Evolve

Ahmed Elsaid, Emergent Biosolution and Ajay Pazhayattil, PhD, cGMP World

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

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

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.

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

Simplicity Wins with Combo Products: An Interview with Jim Collins

PDA Staff Author: Justin Johnson

Effective Strategies for Investigating Media Fill Failures in Sterile Manufacturing

Niravbhai Patel, PhD, and Dhavalkumar Surti, Nivagen Pharmaceuticals, Inc.

Opinion: Revisit Regulatory Expectations for Micro ID in Grade A Environments for Non-growth-based Methods?

Petra Merker, PhD, Bayer AG, Tony Cundell, PhD, Microbiological Consulting, LLC, and Cynthia Martindale, Applied Rapid Microbiology Specialists, Ltd.

Building an Effective Data Integrity Program Using Risk Management

Chinmoy Roy, PDA

Reducing Human Error for Manual Visual Inspection

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

Balancing Act: Human vs. Machine Inspection in Pharmaceutical Manufacturing

Tejesh Marsale, PCI Pharma Services