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Quality and Regulatory

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News Brief: FDA Releases Draft Guidance on 21 CFR 211.110 Compliance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

Biopharmaceutical Manufacturing Conference

Louise Uí Fhatharta, Pharmalex

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

Sprinting Toward the Lab of the Future: Practical Steps to Get Started

Ashley McMillan, Veeva Vault LIMS

Transforming Pharmaceutical Inspections with Human-Like Robot AI

Romain Veillon, GSK

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

PDA Hosts Industry Focused Roundtable on Speeding Innovation through Global Regulatory Convergence

Glenn E. Wright, PDA President and CEO

Navigating the CDMO-Sponsor Partnership

Morten Munk, FUJIFILM Diosynth Biotechnologies , Virginia Boldt, Accenture , and Andrew Chang, PhD, PhD, Novo Nordisk

An Alternative and Sustainable BET Designed for Patient Safety

Parampal Deol, PhD, Charles River Laboratories

Industry Expert Discusses the Value of the PDA/FDA Joint Regulatory Conference 2024

PDA

A Holistic Approach to CCI is a Deterministic Approach

Oliver Stauffer, PTI

Pathway to a Contamination Control Strategy

Londa Ritchey and Patrick Nieuwenhuizen, PharmaLex

FDA/CDER Readying Draft Guidance on AI to Support Regulatory Decision-Making

Justin Johnson and Walter Morris, PDA

Meeting the ATMP Moment with Robotics and Automation

Josh Russell, AST