PDA Letters (Cards)

Manufacturing Capacity Expansion and Validation for Autologous Cell Therapies

By: Stephan Krause, PhD, Bristol Myers Squibb Adam Boyer, Bristol Myers Squibb

Aseptic Transfers to Grade A

By: Julian Petersen Richard Denk, Skan AG

On The Issue: PDA India Chapter

PDA, Inc.

Points to Consider on Aseptic Filling Technologies Nearing Completion

By: Rebecca Brewer

Welcome New PDA Germany/Austria/Switzerland Chapter!

By: Julian Petersen

Intrinsic Sterile Connection Devices

By: William Peterson

Digitization Advancing in the Near Future

By: Toni Manzano

Nominations for PDA Board of Directors Open to May 8

PDA, Inc.

Legacy Filling Lines Evolve

By: Ahmed Elsaid, Emergent Biosolution Ajay Pazhayattil, PhD, cGMP World

Community News Quarterly

PDA, Inc.

On The Issue: PDA Training

PDA, Inc.

Building a Quality Culture Using Quality Systems

By: Ron Branning, GXP Quality Systems, LLC

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

By: Hal Baseman, ValSource, Inc. Gabriele Gori

The Key to Compliance with Annex 1 and Risk Based Regulations

By: Noelle Clifford, PharmaLex

A View on the Revised Annex 1

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

Elevating Sterile Manufacturing

By: Simone Biel, PhD, Merck

The14th Parenteral Packaging Conference

By: Philippe Lauwers, Terumo Pharmaceutical Solutions

Sterility Testing of Cell and Gene Therapies

By: Zachary Beck, Eurofins

On The Issue: The Quality Management Maturity Model

PDA, Inc.

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

By: Maria Jacobs, PhD, Pfizer, Inc. Katie Bevard, Amgen Jason Kerr, Moderna