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  • Aseptic Processing & Sterilization

Contamination Control Strategies: A Path for Quality & Safety

  • Subrata Chakraborty, Gxpfont Consulting Group and Hal Baseman, ValSource, Inc.
  • May 18, 2022
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  • Quality & Regulatory

You Had Micro Questions, FDA Had Big Answers

  • Marilyn L. Foster, PDA
  • May 4, 2022
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  • Quality & Regulatory

Merck Streamlines Quality Management with the Cloud

  • Mike Jovanis, Vice President of Vault Quality at Veeva Systems
  • Apr 20, 2022
  • Article Categories

Buddy Up in Berlin with New PDA Pals

May 1, 2017
  • People

Regulators, USP Taking a Close Look at Visual Inspection

May 1, 2017
  • Quality & Regulatory

A Case Study in Aseptic Gas Plasma Decontamination

May 1, 2017
  • Aseptic Processing & Sterilization
Members Only Content

Japan Chapter Marks 25 Years at Annual Event

May 1, 2017
  • People
Members Only Content

Human Element Key to Digital Transformation

Apr 25, 2017
  • Manufacturing Science

A QUICK Guide To Selecting a CMO

Apr 18, 2017
  • Quality & Regulatory
Members Only Content

IG Meetings to Address Complexity of New Products

Apr 4, 2017
  • Quality & Regulatory

How to Get Your ATMP From the Lab to the Market

Apr 4, 2017
  • Biopharmaceuticals & Biotechnology
Members Only Content

Viral Safety Approaches for Advanced Therapy Medicinal Products

Apr 4, 2017
  • Biopharmaceuticals & Biotechnology

WHO Should Align with ICH on PACs

Apr 4, 2017
  • Quality & Regulatory

Quality Metrics to Impact Different Pharma Sectors

Mar 14, 2017
  • Quality & Regulatory

Leveraging Video to Improve Operations

Mar 7, 2017
  • Manufacturing Science

Storm Surrounds Clinical Trial Data in China

Feb 7, 2017
  • Quality & Regulatory

Annex 1 Showcases the Need for Clear Guidance

Jan 10, 2017
  • Quality & Regulatory

GMP Oversight of Medicines Manufacturers in the European Union

Nov 14, 2016
  • Quality & Regulatory

When a Routine Trip Becomes a 1980s Comedy of Errors

Oct 4, 2016
  • People
Members Only Content

A Line of Sight Approach for Assessing Aseptic Processing Risk: Part III

Sep 27, 2016
  • Aseptic Processing & Sterilization

PDA Program to Address Post-Approval Hurdles

Aug 24, 2016
  • Quality & Regulatory

When Data Integrity Takes Front and Center Stage

Aug 9, 2016
  • Quality & Regulatory
Members Only Content

Three Questions for MHRA’s David Churchward

Jul 26, 2016
  • Quality & Regulatory
Members Only Content

Four Steps to Conducting a Successful Data Integrity Audit

Jul 19, 2016
  • Quality & Regulatory

A Line of Sight Approach for Assessing Aseptic Processing Risk: Part II

Jul 7, 2016
  • Aseptic Processing & Sterilization

Data Integrity and the Preapproval Inspection

Jun 22, 2016
  • Quality & Regulatory

A Line of Sight Approach for Assessing Aseptic Processing Risk: Part I

May 31, 2016
  • Aseptic Processing & Sterilization

Drug Shortage is a "Wicked Problem"

May 4, 2016
  • Quality & Regulatory

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