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Quality and Regulatory

Microbial Control of Raw Materials Used in Pharmaceuticals

David Jaworski, PDA, Inc.

Missouri Valley Chapter Dinner Taps Inspections/Annex 1

Patrick Kane, Veltek Associates, Inc. and chapter board member

2022 PDA Quality & Regulations Conference

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

GMP Challenges with Time Limitations in Pharma Manufacturing

Tony Cundell, PhD, Microbiological Consulting, LLC

Investigating Out-of-Specification Results for BET

Hayden Skalski, Sievers Instruments

Key Takeaways from the PDA Annex 1 Workshop

Patrick Nieuwenhuizen, PharmaLex

Highlights of the SBIA Generic Drugs Forum

David Jaworski, PDA, Inc.

A Successful Q-Model for New mRNA Line Commissioning & Qualification: Pt. 2

Ahmed Elsaid, Emergent BioSolutons, and Ajay Pazhayattil, Capcium Inc.

PDA BioManufacturing and Lyophilization Conferences: The Start of a Shared Journey

Cristiana Campa, PhD, GSK; Michael R. DeFelippis, PhD, Eli Lilly; Raf De Dier, PhD, Janssen; and Anthony Cannon, MSD

Death by Data Integrity Assessment

Meg Gallwitz, Consultant

A Successful Q-Model for New mRNA Line Commissioning & Qualification: Pt. 1

Ahmed Elsaid, Emergent BioSolutions, and Ajay Pazhayattil, Capcium Inc.

You Had Micro Questions, FDA Had Big Answers

Marilyn L. Foster, PDA

Accelerated COVAX Approvals Maintained Rigorous Review Process

Adam Caruso, Merck & Co.

Guest Editorial: What Might Have Been

Russell E. Madsen, The Williamsburg Group

A supplier's perspective: How can EU GMP Annex I be integrated into the manufacturing of components for container closure systems?

Bettine Boltres, PhD, West Pharmaceutical Services

Zero-Particulates Goal Promotes Continuous Improvement

Subrata Chakraborty, GxPFONT Consulting Group

How to Measure Quality Management Maturity

Denyse Baker, Jeff Broadfoot, Steve Mendivil, Adam Caruso, and Sandra Lueken

Approaches to Data Integrity Assurance: 2021 Workshop

Julie C. Maurhoff, Ultragenyx Pharmaceutical and DI Workshop Planning Committee Member

My Journey to Japan — Sort Of

Marilyn L. Foster, PDA

Four Scenarios of Regulatory Relief from PAS and CBE-30 for CCS and Component Changes

Don Klein, PhD, DLK Consulting Services, Inc.

Guest Editorial: Covid-19 Vaccine and High Stakes of Quality

Tamer Helmy, PhD, Molecular Templates Inc.

Virtual EMA Multistakeholder Meeting on Drug-Device Combination Products

Bettine Boltres, West Pharmaceutical Services Deutschland GmbH & Co KG and Lee Leichter, P/L Biomedical

Breaking Down Computer Systems Validation in a Regulated Environment

Ray Roggero, Medvacon Life Sciences

Modern Quality Professional, Part 2: The Case Studies

Stephan Krause, Adele Chambers, Ryan Courtney, Darrin Cowley, and Anthony Mire-Sluis, AstraZeneca

The Modern Quality Professional Development Tool, Part 1

Stephan Krause, Adele Chambers, Ryan Courtney, Darrin Cowley, and Anthony Mire-Sluis, AstraZeneca

PDA in Print: Quality by Design— An Indispensable Approach to Accelerate Biopharmaceutical Product Development

M. Amin Khan and Cristiana Campa, GSK

Facilitating Continual Improvement, Innovation, and Reducing Drug Shortages through Enhanced Science and Risk-based PACs

Marilyn Foster, PDA

Call for Volunteers: New PDA Standard on Biologics Validation/QC

Christine Roberts, PDA

Virtual Audits in the Time of COVID-19: For the Auditor and the Host

Anna Gilbert, BDO; Robert Greathead, Catalent Pharma Solutions; Michelle Bernards, Manager, Catalent Pharma Solutions

The Product Quality Research Institute – Advancing Regulatory Science through Collaboration

Glenn Wright, PDA