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Quality and Regulatory

Leadership, Layoffs, and Legislation

Katie Bevard, Eli Lilly

News Brief: U.S. FDA Launches AI Tool, Elsa

Justin Johnson, PDA

News Brief: AI and Reshoring Topic of One-Day DC Event

Walt Morris, PDA

PDA Europe and EMA Unite

Toni Manzano, PhD, Aizon

News Brief: Successful AI Pilot Prompts FDA to Launch Full-Scale Integration

Justin Johnson, PDA

News Brief: U.S. FDA Announces Limits to Industry Employees Serving on FDA Advisory Committees

Walter Morris, PDA

Bioburden Monitoring for Primary-Packaging Sterile Manufacturing

Bart Moens, Organon

Understanding the UK’s International Recognition Procedure

Claire Stevenson, PhD, PharmaLex and Aashni Shah, PharmaLex

Global Regulatory Convergence — What If?

Glenn Wright

Knowledge Management and its Relation to Data Integrity

Kristen Anderson, PhD , Klaus Finneiser , Kir Henrici, The Henrici Group , Megan Powdrill , and James L. Vesper, PhD, PDA Knowledge Management Roadmap Team

PDA to Launch First-of-its-Kind Ethics Course on Pharma Manufacturing

Glenn Wright, PDA

GMP Annex 1 Implementation

Andrea Salmaso, Stevanato Group

News Brief: FDA CDER Director Patrizia Cavazzoni Announces Resignation

Walter Morris, PDA

News Brief: More FDA Guidances for the New Year

Walter Morris, PDA

News Brief: FDA Releases Draft Guidance on 21 CFR 211.110 Compliance

Justin Johnson, PDA

Points to Consider When Applying QRM

Douglas Campbell, InterPro QRA

Important Takeaways from the PDA/FDA Joint Regulatory Conference

Justin Johnson, PDA

The Latest Current FDA CBER Initiatives

Edward H. Trappler, Lyophilization Technology, Inc. and Denise Miller, Lyophilization Technology

Q&A on the Revised PDA Technical Report No. 22

Subrata Chakraborty, PhD, INOVR , Vanessa Figueroa, VVF Science , and Marcia C. Baroni, MBA, Emergent BioSolutions Inc

Cross-Industry Insights: Leveraging Quality-Enabling Behaviors for Success

Jason Kerr, Moderna

Microbial Ingress No Longer an Effective CCI Test Method

Oliver Stauffer, PTI and Tyler Harris, PTI

Navigating New Horizons: Discoveries from the 2024 PDA Annual Meeting

Michelle Tu, Qvin

Understanding Japan Quality

Antonio Burazer, Takeda

PDA Manufacturing Meets Legislation

Dr. Bettine Boltres and Ana Marques Kuschel, PhD, WEST Pharmaceutical Services

The High Cost of Cheap Drugs

Martin VanTrieste, Civica Rx

News Brief: FDA’s Reorganization Plan Comes into Focus at PDA/FDA Joint Regulatory Conference

Walter Morris, PDA

News Brief: Navigating Regulatory Uncertainty

Justin Johnson, PDA

Validating NGS-Based Assays In-House for Virus Safety Assessment

Christoph Bredack, PhD, Genedata

Process Hold Times: What is it and Why is it Important?

Robert Dream, MS, Nivagen Pharmaceuticals and Bruce Loxley, GSK

New Training Course – Manage your Aseptic Filling Line

Julian Petersen, groninger & co. gmbh