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Aseptic Processing & Sterilization

Harnessing HACCP for Aseptic Filling

Abu Sadat Muhammod Saiyem, Square Pharmacuetical Limited

Get Ecstatic for Aseptic

David Keen, Ecolab Life Sciences

Bioburden Monitoring for Primary-Packaging Sterile Manufacturing

Bart Moens, Organon

What is the Best Way to Control Contamination on the Hands?

PDA Staff Author: David Jaworski, MBA

Challenges in Sterilizing Indirect Product-Contact Surfaces

Cecilia Pierobon, STERIS

Five Important Insights from the PDA Europe Annex 1 Event

Patrick Nieuwenhuizen, PharmaLex

GMP Annex 1 Implementation

Andrea Salmaso, Stevanato Group

Modern Microbial Methods Supporting a Contamination Control Strategy

Allison Scott, Particle Measuring Systems, et al.

Biopharmaceutical Manufacturing Conference

Louise Uí Fhatharta, Pharmalex

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

New Training Course – Manage your Aseptic Filling Line

Julian Petersen, groninger & co. gmbh

How Best to Act Locally to Manage Globally in Aseptic Processing

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

Aseptic Transfers to Grade A

Julian Petersen, groninger & co. gmbh and Richard Denk, SKAN AG

Points to Consider on Aseptic Filling Technologies Nearing Completion

Rebecca Brewer, Quality Executive Partners

Intrinsic Sterile Connection Devices

William Peterson, Merck

Legacy Filling Lines Evolve

Ahmed Elsaid, Emergent Biosolution and Ajay Pazhayattil, PhD, cGMP World

The Key to Compliance with Annex 1 and Risk Based Regulations

Noelle Clifford, PharmaLex, PharmaLex

A View on the Revised Annex 1

Antonio Burazer, Takeda , Alexander Artau, Sanofi , Elisabeth Wagner,  CSL Behring , and Joseph Straub, Merck

Biosafety Guidelines for Handling Microorganisms in Microbiology Laboratories

Tony Cundell, PhD, Microbiological Consulting, LLC

Microbial Control During Low-Risk Aseptic Processing

PDA Staff Author: David Jaworski, MBA

To See or Not to See?

Andrea Sardella, National Research Council, Stevanato Group and Hanns-Christian Mahler, PhD, ten23 health

Advanced Nucleic Acid Testing Methods Rise to the Challenge

Manjula Aysola , Danielle DiTirro , Pamela Hamill , and Alison Armstrong, MIlliporeSigma

Seven Key Takeaways from PDA’s Viral Safety for ATMPs Workshop and Virus Conference Events

Alison Armstrong, PhD, Merck KGaA, Andy Bailey, ViruSure, Sean O’ Donnell, PhD, Eli Lily, and Sebastian Teitz, Biopharma Excellence

Opinion: Revisit Regulatory Expectations for Micro ID in Grade A Environments for Non-growth-based Methods?

Petra Merker, PhD, Bayer AG, Tony Cundell, PhD, Microbiological Consulting, LLC, and Cynthia Martindale, Applied Rapid Microbiology Specialists, Ltd.

PDA Microbiology Conference 2022 Presentation: Answers You Have Been Wanting

Harolyn Clow, Teva Pharmaceuticals, and Don Singer, Ecolab Life Sciences

Reducing Human Error for Manual Visual Inspection

Vanessa Vasadi Figueroa, QxP and VVF Science, and Robert Ferer, QxP

Aligning Global Regulatory Guidance Documents for Container Closure Integrity

Oliver Stauffer, PTI

The Importance of Visual Inspection in Injection of Parenteral Drug Products

Izi Bruker, PhD, Kymanox, et al.