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Quality and Regulatory

Sponsored by Particle Measuring Systems
Normalized Data in Microbial Continuous Monitoring

Rosa Laronga, Particle Measuring Systems , Giulia Paternò, Particle Measuring Systems , and Serena Steidl, Particle Measuring Systems

News Brief: FDA Cracks Down on Misleading Drug Ads

Justin Johnson, PDA

Teaching the Plant

Abhinav Arora

FDA Expands Use of Unannounced Foreign Inspections

Louise Uí Fhatharta, Pharmalex

The PDA Regulatory Conference Features Over 30 FDA Experts on the Agenda

Walter Morris, PDA

Beyond the Limits

Yanet Flor, GMP Check Solutions

News Brief: FDA Announed FDA PreCheck

Justin Johnson, PDA

News Brief: PDA AI Glossary Now Available

Walter Morris, PDA

News Brief: U.S. FDA Head Makary Says Severity of FDA Layoff Overstated

Walter Morris, PDA

News Brief: Sean Keveney Appointed Chief Counsel of FDA

Justin Johnson, PDA

Equivalence Testing of BFPCs in Grade A Environments

Mads Lichtenberg, PhD, Fujifilm Biotechnologies, et. al.

News Brief: FDA Appoints Dr. George Tidmarsh as Director of CDER

Walter Morris, PDA

News Brief: FDA Releases 200 Drug Rejection Letters

Justin Johnson, PDA

Planning for a Dual-Method Future

Nora Blair, Charles River

News Brief: FDA Finalizes Guidance on Remote Regulatory Assessments

Justin Johnson, PDA

News Brief: FDA Issues Draft ICH Stability Guideline for Public Comment

Walter Morris, PDA

Leading the Turnaround

Troy Chavis, PrecisionPharma Manufacturing Solutions, LLC

Effective AI Deployment in Drug Manufacturing

Peter Makowenskyj, MEng, G-CON Manufacturing and Toni Manzano, PhD, Aizon

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, PDA

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

Benefits and Opportunities of Using the PDA AI Glossary

Toni Manzano, PhD, Aizon , Hue Kwon, PhD, Sobi , and Sabine Hauck, Consultant