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  • Manufacturing Science

Digital Transformation without the Transformation

  • David Hubmayr, Takeda Pharmaceuticals
  • Sep 28, 2022
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  • Manufacturing Science
  • Quality & Regulatory

GMP Challenges with Time Limitations in Pharma Manufacturing

  • Tony Cundell, PhD, Microbiological Consulting, LLC
  • Sep 8, 2022
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  • Quality & Regulatory
  • Aseptic Processing & Sterilization

Investigating Out-of-Specification Results for BET

  • Hayden Skalski, Sievers Instruments
  • Aug 17, 2022
  • Article Categories

Women in Biotech Panel Offers Career Advice for All Sexes

Jul 18, 2017
  • People

India Chapter Holds Successful Biologics Workshop

Jul 10, 2017
  • People
Members Only Content

Difficult-to-Inspect Drugs Require New Processes

Jul 10, 2017
  • Biopharmaceuticals & Biotechnology

When Microbiologists Collaborate, Great Things Happen

Jul 10, 2017
  • Aseptic Processing & Sterilization

Can Single-Use Components Be Commodities?

Jul 10, 2017
  • Manufacturing Science
Members Only Content

Regulatory Submissions: No Longer Paper-Based

Jul 10, 2017
  • Quality & Regulatory
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Build Your Network at the PDA/FDA JRC

Jul 10, 2017
  • People

OPQ Establishes Manufacturing Science CoE

Jul 10, 2017
  • Quality & Regulatory

PDA Summer Reading for 2017

Jul 10, 2017
  • People
Members Only Content

A Maturing Model of Quality

Jul 10, 2017
  • Quality & Regulatory

Industry Expert Weighs in on Quality Metrics

Jul 10, 2017
  • Quality & Regulatory

U.S., UK Regulators Share Passion for Quality Culture

Jul 10, 2017
  • Quality & Regulatory
Members Only Content

PDA’s 4th Metrics Conference

Jul 10, 2017
  • Quality & Regulatory
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PQRI Establishes Thresholds for L&E Identification

Jun 27, 2017
  • Manufacturing Science
Members Only Content

Knowledge is Power

Jun 13, 2017
  • Supply Chain & Outsourcing

Perspectives on Packaging

Jun 8, 2017
  • Manufacturing Science

Industry Experts: Quality Requires Proactive Approach

May 30, 2017
  • Quality & Regulatory

The Future of Glass in Parenteral Packaging

May 30, 2017
  • Manufacturing Science
Members Only Content

New Guidance for Visual Inspection Available

May 30, 2017
  • Quality & Regulatory

Gowning Requirement for Blow-Fill-Seal Technology

May 30, 2017
  • Aseptic Processing & Sterilization
Members Only Content

MAbs Require Ongoing Dialogue

May 30, 2017
  • Biopharmaceuticals & Biotechnology

Prefilled Syringes Bring Patient to the Forefront

May 30, 2017
  • Manufacturing Science

Microbiologists Put Under the Microscope

May 30, 2017
  • People
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How to Use QbD to Select Packaging Components

May 30, 2017
  • Quality & Regulatory

Putting the Pieces Together

May 30, 2017
  • Manufacturing Science

Creating a Global Incentive for Pharma

May 23, 2017
  • Quality & Regulatory

Lower the H202 Concentrations in Your Isolator with One Easy Upgrade

May 2, 2017
  • Aseptic Processing & Sterilization
Members Only Content

Hear From Industry, FDA Leaders on the Issues of the Day

May 2, 2017
  • Quality & Regulatory

Pharma Has its Head in the Cloud

May 1, 2017
  • Manufacturing Science
Members Only Content

Cost of Quality Still a Factor

May 1, 2017
  • Quality & Regulatory
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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
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Human Element Key to Digital Transformation

Apr 25, 2017
  • Manufacturing Science

A QUICK Guide To Selecting a CMO

Apr 18, 2017
  • Quality & Regulatory
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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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