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Quality and Regulatory

Harnessing HACCP for Aseptic Filling

Abu Sadat Muhammod Saiyem, Square Pharmacuetical Limited

Disruptive Innovations Shaping the GLP-1 Landscape

Anya Hillery, PhD, Freelance Medical Writer

News Brief: FDA Releases 200 Drug Rejection Letters

Justin Johnson, PDA

Facilitating Adoption of Modern Microbial Methods

Allison Scott, BWT Pharma & Biotech Inc, et al.

Managing Talent Risk in Emerging Cell and Gene Therapy Biotechs

Tamer Helmy, PhD, Molecular Templates

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

Beyond the Vial

Philippe Lauwers, Terumo Pharmaceutical Solutions and Coralie Richard, Eli Lilly and Company

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

Engineering Excellence in Container Closure Integrity Testing

Oliver Stauffer, PTI

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:  EMA and HMA Joint Workplan on Data and AI in Medicines Regulation

Walter Morris, PDA

The Need for Manufacturing Speed

Michael Anyadiegwu, PhD , Renske Hesselink, PhD , and Ingrid Kromann, CEPI

News Brief: President Trump Plans Actions to Reduce Regulatory Barriers to Domestic Pharma Manufacturing

Justin Johnson, PDA

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

Walter Morris, PDA

Expert Perspectives in KM Between Sponsors and Third Parties

Dr. Bettine Boltres , Danica Brown , Beth Haas, Haas Pharma Consulting LLC , Marty Lipa , Rhonda Sundberg , and Joseph Thomas, PDA Knowledge Management Roadmap Team

Bioburden Monitoring for Primary-Packaging Sterile Manufacturing

Bart Moens, Organon

Ethical Dilemmas in Pharma: Pharma's Toughest Decisions

Martin VanTrieste, Civica Rx

Understanding the UK’s International Recognition Procedure

Claire Stevenson, PhD, PharmaLex and Aashni Shah, PharmaLex

Challenges in Sterilizing Indirect Product-Contact Surfaces

Cecilia Pierobon, STERIS

Global Regulatory Convergence — What If?

Glenn Wright, PDA

Bridging the Gap Between Employers and Early Career Professionals to Succeed Together

Justin Johnson, 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

From Lab to Market

Tejesh Marsale, PCI Pharma Services