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Quality and Regulatory

Joint Associations’ Response Letter on EU Annex 1 Draft

Hal Baseman, Valsource, Inc and Annex 1 Response Team Co-Chair

PDA Requests Pause to USP’s Biologics Nomenclature Proposal

PDA

2020 PDA Pharmacopeia Conference

Kevin T. Moore, PhD, U. S. Pharmacopeia, and J. Mark Wiggins, Global Pharmacopoeia Solutions LLC

FDA Shares Views on ICH Q12, Continuous Improvement and Innovation

Marilyn Foster, PDA

Data Integrity: The New World of Virtual Audits and Investigations

Kir Henrici, The Henrici Group, and Monica Cahilly, Green Mountain Quality Assurance, LLC

Best Practice Guide for Using KPI’s/Metrics

Bernhard Hinsch, Hinsch Consulting

Regulator Develops Remote Inspection Process Due to Pandemic

Vladislav Shestakov, Russian State Institute of Drugs and Good Practices, and Elizabeth Meyers, Amgen

PDA Comments Address Risk Management Approach to Gene Therapy CMC

Rebecca Stauffer, PDA

Guest Editorial: A Report on the COVID-19 Situation in India

Ivy Louis, Vienni Training and Consulting

Task Group Formed to Craft PDA Quality Culture Standard

Marilyn Foster, PDA

Data Integrity: From the Basics to Big Data

David Hubmayr, CSL Behring

5.0 Ways Quality 4.0 Will Improve Manufacturing

Snehal Srikrishna, Veeva Systems

A Glimpse at FDA’s Micro Regulations

Rebecca Stauffer, PDA

EPA Hearing on EtO Draws Debate

Rebecca Stauffer, PDA

The Product Quality Leader Team Part I: Building the PQL Role

Stephan Krause, PhD; Mariam Khan; Callum Chapman; Rob Gaglione; Andy Spasoff; Anthony Mire-Sluis, AstraZeneca

ICH Q9: Quality Risk Management Revisions on Horizon

Rebecca Stauffer, PDA

Plunging into Six Sigma

Stephenie Overman

Get Your Data Integrity Basics Down for Success

Silvia Martins, Five Validation

An Inside Look at the 2019 PDA Quality Week

Eva Urban, CSL Behring, Susan Schniepp, Regulatory Compliance Associates, Lori Richter, ValSource, and Ghada Haddad, Merck

Spotlight on Packaging Regulations and CCI

Rebecca Stauffer, PDA

Incorporating QRM into Cell and Gene Therapy Processes

Lori Richter, ValSource, and Ghada Haddad, Merck

Human Error Causes OOS Investigation

Rebecca Stauffer and Madeline Cusick, PDA

Why is the EU Medical Device Regulation So Critical?

Olivia Henderson, PhD, and Kesley Gallagher, Amgen

Follow the Audit Trail Breadcrumbs

Ann Milliman, Baxter Healthcare Corporation

U.S. FDA Continues Data Integrity Focus

Lina Genovesi

Foreign Particles in Bull’s Eye of Global Reg Agencies

Hirohito Katayama, PhD, Bayer Yakuhin, and John Shabushnig, PhD, Insight Pharma Consulting

PDA/FDA JRC Conference Returns!

Program Planning Committee

PDA Comments: Ph. Eur. Tackles Endotoxin Alternative rFC

Rebecca Stauffer, PDA

The Role of Project Managers in Pharma

Kerstin Wilken, PhD, PDA

The Pharmacopeia in the 21st Century

Susanne Keitel, PhD, EDQM