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Quality and Regulatory

Achieving Top Management’s Interest Through the Use of KPIs and QPIs

Yanet Flor, SQA Services, Inc

2023 PDA Universe of Pre-Filled Syringes and Injection Devices Conference!

Theresa Bankston, PhD, Beckton Dickenson, and Alessandro Morandotti, Stevanato Group

Industry Remains Divided on Quality Management Maturity Proposal

David Jaworski and Josh Eaton, PDA, Inc.

Are Your Drug or Device Endotoxins Up to Specs?

Edward C. Tidswell, Merck & Co.

Vaccine Development Discussion at PDA Europe Biomanufacturing Conference

Maxwell De Long, Genetech

The Urgency for Robotization and Automation

Toni Manzano, Aizon, and Dieter Bachman, PhD, J&J

You’re Invited to the 2023 PDA Virus Conference

Alison Armstrong, Merck KGaA, and Andy Bailey, ViruSure

Robotics and Automation in Pharmaceutical Production

Andrea Tanzini, Staubli Robotics

We're Going to New Orleans! Let’s Talk about Contamination Control and the Annex 1 Revision

Justin Johnson

Key Takeaways from the 2022 PDA Annex 1 Workshop in Dublin

Eilish Kelly and Patrick Nieuwenhuizen, PharmaLex

Joint Regulatory Conference: Bringing Better Innovation and Communication Moving Forward

Londa Ritchey, PharmaLex

Upcoming CCS Workshop — A New Direction in Workshop Design

Glenn Wright, PDA, Inc.

The Complex Process for Sterile Filling and Points to Consider

Mauro Giusti, Eli Lilly Italia, and Rebecca Brewer, QxP

Putting AI to the Test with Continued Process Verification

Marilyn L. Foster and Josh Eaton, PDA, Inc.

Modernizing Risk Assessment for Legacy Products

Sanjay Rajpal Sharma, Lupin

Turning Annual Product Quality Reviews into a Strategic Advantage

Sofia Lange, Veeva Systems

Technological Solutions to Overcome the New Annex 1 Challenges

Marco Bianchi, De Lama S.p.A.

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.