PDA Letter
Home / PDA Letter / Quality and Regulatory

Quality and Regulatory

Guest Editorial: What Might Have Been

Russell E. Madsen, The Williamsburg Group

A supplier's perspective: How can EU GMP Annex I be integrated into the manufacturing of components for container closure systems?

Bettine Boltres, PhD, West Pharmaceutical Services

Zero-Particulates Goal Promotes Continuous Improvement

Subrata Chakraborty, GxPFONT Consulting Group

How to Measure Quality Management Maturity

Denyse Baker, Jeff Broadfoot, Steve Mendivil, Adam Caruso, and Sandra Lueken

Approaches to Data Integrity Assurance: 2021 Workshop

Julie C. Maurhoff, Ultragenyx Pharmaceutical and DI Workshop Planning Committee Member

My Journey to Japan — Sort Of

Marilyn L. Foster, PDA

Four Scenarios of Regulatory Relief from PAS and CBE-30 for CCS and Component Changes

Don Klein, PhD, DLK Consulting Services, Inc.

Guest Editorial: Covid-19 Vaccine and High Stakes of Quality

Tamer Helmy, PhD, Molecular Templates Inc.

Virtual EMA Multistakeholder Meeting on Drug-Device Combination Products

Bettine Boltres, West Pharmaceutical Services Deutschland GmbH & Co KG and Lee Leichter, P/L Biomedical

Breaking Down Computer Systems Validation in a Regulated Environment

Ray Roggero, Medvacon Life Sciences

Modern Quality Professional, Part 2: The Case Studies

Stephan Krause, Adele Chambers, Ryan Courtney, Darrin Cowley, and Anthony Mire-Sluis, AstraZeneca

The Modern Quality Professional Development Tool, Part 1

Stephan Krause, Adele Chambers, Ryan Courtney, Darrin Cowley, and Anthony Mire-Sluis, AstraZeneca

PDA in Print: Quality by Design— An Indispensable Approach to Accelerate Biopharmaceutical Product Development

M. Amin Khan and Cristiana Campa, GSK

Facilitating Continual Improvement, Innovation, and Reducing Drug Shortages through Enhanced Science and Risk-based PACs

Marilyn Foster, PDA

Call for Volunteers: New PDA Standard on Biologics Validation/QC

Christine Roberts, PDA

Virtual Audits in the Time of COVID-19: For the Auditor and the Host

Anna Gilbert, BDO; Robert Greathead, Catalent Pharma Solutions; Michelle Bernards, Manager, Catalent Pharma Solutions

The Product Quality Research Institute – Advancing Regulatory Science through Collaboration

Glenn Wright, PDA

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