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Quality and Regulatory

Aligning Global Regulatory Guidance Documents for Container Closure Integrity

Oliver Stauffer, PTI

2023 PDA Quality & Regulations Conference

Patrick Costello, AbbVie Pharmaceuticals, and Vinny Browning, Amgen (Co-Chairs)

Microbiologists and Training: A Crucial Quality Connection

Donald C. Singer, Ecolab, and Radha Tirumalai, PhD, Merck & Co., Inc.

The Difficult Task of Solving Contamination Puzzles

Paula Peacos and Kim Sobien, ValSource, Inc.

Artificial Intelligence and Machine Learning in the Early Stage of a Product Life Cycle

By Maria Batalha, Rui Almeida, Ângela Martinho and Daniel Pais, PhD, Valgenesis

Per- and Polyfluoroalkyl Substances Ban Starting 2027

Ana Kuschel, PhD, West Pharmaceutical Services

Quality Culture Post-Pandemic

Tamer Helmy, PhD

Macro Impacts from the Micro-Universe

Kurt Jaecques, GSK, and Vineeta A. Pradhan, U.S. FDA

The 2023 PDA BioManufacturing Conference Lands in Seville, Spain

Cristiana Campa, PhD, GSK, and Elisabeth Vachette, Sartorius Stedim Biotech

Maintaining Compliance with Deviation Reports: A Glimpse into the 2023 PDA Mastering Deviations Workshop

Kate Malachowski, Novavax

Making The Most of External Signals for Internal Learning and Knowledge Management

Denyse D. Baker, Eli Lilly and Company, Jackie Veivia-Panter, BioCentriq, and Janeen Skutnik-Wilkinson, Moderna, Inc.

2023 PDA Particle Control in Biopharmaceuticals

Roman Mathaes, Clear Solutions Laboratories

From Risk Assessment to Employee Training

Vinicius Tarantino, GxP-CC

Achieving Top Management’s Interest Through the Use of KPIs and QPIs

Yanet Flor, SQA Services, Inc

2023 PDA Universe of Pre-Filled Syringes and Injection Devices Conference!

Theresa Bankston, PhD, Beckton Dickenson, and Alessandro Morandotti, Stevanato Group

Industry Remains Divided on Quality Management Maturity Proposal

David Jaworski and Josh Eaton, PDA, Inc.

Are Your Drug or Device Endotoxins Up to Specs?

Edward C. Tidswell, Merck & Co.

Vaccine Development Discussion at PDA Europe Biomanufacturing Conference

Maxwell De Long, Genetech

The Urgency for Robotization and Automation

Toni Manzano, Aizon, and Dieter Bachman, PhD, J&J

You’re Invited to the 2023 PDA Virus Conference

Alison Armstrong, Merck KGaA, and Andy Bailey, ViruSure

Robotics and Automation in Pharmaceutical Production

Andrea Tanzini, Staubli Robotics

We're Going to New Orleans! Let’s Talk about Contamination Control and the Annex 1 Revision

Justin Johnson

Key Takeaways from the 2022 PDA Annex 1 Workshop in Dublin

Eilish Kelly and Patrick Nieuwenhuizen, PharmaLex

Joint Regulatory Conference: Bringing Better Innovation and Communication Moving Forward

Londa Ritchey, PharmaLex

Upcoming CCS Workshop — A New Direction in Workshop Design

Glenn Wright, PDA, Inc.

The Complex Process for Sterile Filling and Points to Consider

Mauro Giusti, Eli Lilly Italia, and Rebecca Brewer, QxP

Putting AI to the Test with Continued Process Verification

Marilyn L. Foster and Josh Eaton, PDA, Inc.

Modernizing Risk Assessment for Legacy Products

Sanjay Rajpal Sharma, Lupin

Turning Annual Product Quality Reviews into a Strategic Advantage

Sofia Lange, Veeva Systems

Technological Solutions to Overcome the New Annex 1 Challenges

Marco Bianchi, De Lama S.p.A.