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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
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  • Manufacturing Science

Initial Evaluation Roadmap for Modern Microbial Methods

  • Claire Fritz Briglia, Vedere Solutions LLC, et al.
  • Apr 6, 2022
  • Article Categories
Rich Levy Retires; Shanker Gupta to serve as Acting JPST Editor

Rich Levy Retires; Shanker Gupta to serve as Acting JPST Editor

May 16, 2022
  • People
2021 PDA Honor Awards: Martin VanTrieste, Michael S. Korczynski and Edward Smith Awards

2021 PDA Honor Awards: Martin VanTrieste, Michael S. Korczynski and Edward Smith Awards

May 12, 2022
  • People
You Had Micro Questions, FDA Had Big Answers

You Had Micro Questions, FDA Had Big Answers

May 4, 2022
  • Quality & Regulatory
Parenteral Packaging 2022: A Q&A with the Conference Chairs

Parenteral Packaging 2022: A Q&A with the Conference Chairs

Apr 28, 2022
  • Supply Chain & Outsourcing
  • Aseptic Processing & Sterilization
Merck Streamlines Quality Management with the Cloud

Merck Streamlines Quality Management with the Cloud

Apr 20, 2022
  • Quality & Regulatory
Initial Evaluation Roadmap for Modern Microbial Methods

Initial Evaluation Roadmap for Modern Microbial Methods

Apr 6, 2022
  • Manufacturing Science
How Ergonomics and Cleaning Reduce Repetitive Stress Injuries and Contamination in Microbiological Quality-Control Workflows

How Ergonomics and Cleaning Reduce Repetitive Stress Injuries and Contamination in Microbiological Quality-Control Workflows

Mar 16, 2022
  • Manufacturing Science
Members Only Content
The Role of Peer Review in the Success of the PDA Journal of Pharmaceutical Science and Technology

The Role of Peer Review in the Success of the PDA Journal of Pharmaceutical Science and Technology

Mar 10, 2022
  • People
Science-Based Approach to CCI Met with Enthusiasm

Science-Based Approach to CCI Met with Enthusiasm

Mar 8, 2022
  • Manufacturing Science
Long-Distance Leadership: Managing a Remote or Hybrid Workforce the Right Way

Long-Distance Leadership: Managing a Remote or Hybrid Workforce the Right Way

Mar 2, 2022
  • People
PDA "Just Right" for John Shabushnig

PDA "Just Right" for John Shabushnig

Feb 25, 2022
  • People
Chair

Chair's Message: Busy Week in Dallas Marks Return to Live Events

Feb 22, 2022
  • People
PDA Letter Article of the Year

PDA Letter Article of the Year

Feb 16, 2022
  • People
Guest Editorial: What Might Have Been

Guest Editorial: What Might Have Been

Feb 10, 2022
  • Quality & Regulatory
  • Aseptic Processing & Sterilization
PDA Visual Inspection Forum Returns; Lands in Berlin in 2022

PDA Visual Inspection Forum Returns; Lands in Berlin in 2022

Feb 8, 2022
  • Manufacturing Science
  • Aseptic Processing & Sterilization
A supplier

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

Feb 3, 2022
  • Supply Chain & Outsourcing
  • Quality & Regulatory
President

President's Message: 2021, A Challenging Year for Everyone

Jan 28, 2022
  • People
Past Leader Spotlight: Nikki Mehringer, Volunteered to Volunteer 

Past Leader Spotlight: Nikki Mehringer, Volunteered to Volunteer 

Jan 25, 2022
  • People
Zero Defect – A Competitive Advantage

Zero Defect – A Competitive Advantage

Jan 19, 2022
  • Quality & Regulatory
Taking the Fear Out of Contamination: Surfaces, Water, and Air, Oh My!

Taking the Fear Out of Contamination: Surfaces, Water, and Air, Oh My!

Jan 5, 2022
  • Aseptic Processing & Sterilization
2021 was a Challenging Year

2021 was a Challenging Year

Jan 4, 2022
  • People
5 Agreements for Your Future Culture

5 Agreements for Your Future Culture

Dec 15, 2021
  • People
PDA COVID-19 Task Force

PDA COVID-19 Task Force

Dec 7, 2021
  • People
  • Supply Chain & Outsourcing
Inspection Resources Hot Topic during

Inspection Resources Hot Topic during 'Ask the Regulators' at PDA/FDA JRC

Dec 3, 2021
  • Quality & Regulatory
PDA Assists EMA with Survey about Supply Challenges Related to the Availability of Single-Use-System Components

PDA Assists EMA with Survey about Supply Challenges Related to the Availability of Single-Use-System Components

Nov 30, 2021
  • Supply Chain & Outsourcing
Contamination Control Strategies: You have questions, we have answers

Contamination Control Strategies: You have questions, we have answers

Nov 17, 2021
  • Manufacturing Science
  • Aseptic Processing & Sterilization
Past Leader Spotlight: Rebecca Devine from FDA CBER to PDA Chair

Past Leader Spotlight: Rebecca Devine from FDA CBER to PDA Chair

Nov 11, 2021
  • People
PDA In Print: Management of Nonconformances for Temperature-Sensitive Products

PDA In Print: Management of Nonconformances for Temperature-Sensitive Products

Nov 9, 2021
  • Supply Chain & Outsourcing
Thanks, Science!

Thanks, Science!

Nov 3, 2021
  • Manufacturing Science
Annex 1 and the New Revision — Setting New Expectations

Annex 1 and the New Revision — Setting New Expectations

Oct 20, 2021
  • Aseptic Processing & Sterilization
PDA’s Honor Awards Program

PDA’s Honor Awards Program

Oct 13, 2021
  • People
Zero-Particulates Goal Promotes Continuous Improvement

Zero-Particulates Goal Promotes Continuous Improvement

Oct 6, 2021
  • Quality & Regulatory
Three Past Chairs Discuss PDA Careers

Three Past Chairs Discuss PDA Careers

Sep 30, 2021
  • People
How to Measure Quality Management Maturity

How to Measure Quality Management Maturity

Sep 23, 2021
  • Quality & Regulatory
NEPDA Awards Its 2021 Scholarships

NEPDA Awards Its 2021 Scholarships

Sep 15, 2021
  • People
Approaches to Data Integrity Assurance: 2021 Workshop

Approaches to Data Integrity Assurance: 2021 Workshop

Sep 9, 2021
  • Quality & Regulatory
COVID-19 Puts Focus on Airborne Virus and Pathogenic Microorganism Detection Methods

COVID-19 Puts Focus on Airborne Virus and Pathogenic Microorganism Detection Methods

Sep 8, 2021
  • Manufacturing Science
COVID-19 Related Shortages of Manufacturing Components — There is a Way Through!

COVID-19 Related Shortages of Manufacturing Components — There is a Way Through!

Aug 25, 2021
  • Manufacturing Science
COVID-19 and the Need for an LAL Alternative

COVID-19 and the Need for an LAL Alternative

Aug 19, 2021
  • Manufacturing Science
My Journey to Japan — Sort Of

My Journey to Japan — Sort Of

Aug 17, 2021
  • Quality & Regulatory
Four Scenarios of Regulatory Relief from PAS and CBE-30 for CCS and Component Changes

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

Aug 11, 2021
  • Quality & Regulatory
PDA in Print: Planning for Effective Use of Technology for Remote Inspections

PDA in Print: Planning for Effective Use of Technology for Remote Inspections

Aug 5, 2021
  • Quality & Regulatory
Guest Editorial: Covid-19 Vaccine and High Stakes of Quality

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

Aug 3, 2021
  • Quality & Regulatory
PDA’s Critical Role in Advancing Manufacturing Science

PDA’s Critical Role in Advancing Manufacturing Science

Jul 29, 2021
  • Manufacturing Science
  • People
How close are we to closed processing?

How close are we to closed processing?

Jul 27, 2021
  • Manufacturing Science
The PDA Community Remembers Long-Time Member and Publisher, Amy Davis

The PDA Community Remembers Long-Time Member and Publisher, Amy Davis

Jul 22, 2021
  • People
Past Leader Spotlight: Fred Carleton, President 1977-1979, Executive Director 1988-1991

Past Leader Spotlight: Fred Carleton, President 1977-1979, Executive Director 1988-1991

Jul 20, 2021
  • People
Virtual EMA Multistakeholder Meeting on Drug-Device Combination Products

Virtual EMA Multistakeholder Meeting on Drug-Device Combination Products

Jul 14, 2021
  • Quality & Regulatory
PDA Summer Reading 2021

PDA Summer Reading 2021

Jul 8, 2021
  • People
PDA Southern California Chapter Congratulates PDA Student Chapter Grads

PDA Southern California Chapter Congratulates PDA Student Chapter Grads

Jul 1, 2021
  • People
Past Leader Spotlight: Nathan Kirsch, PDA President 1965-1966

Past Leader Spotlight: Nathan Kirsch, PDA President 1965-1966

Jun 30, 2021
  • People
Modern Quality Professional, Part 3: Using the Scoring System

Modern Quality Professional, Part 3: Using the Scoring System

Jun 23, 2021
  • Quality & Regulatory
President’s Message: PDA Mid-Year Update

President’s Message: PDA Mid-Year Update

Jun 15, 2021
  • People
Breaking Down Computer Systems Validation in a Regulated Environment

Breaking Down Computer Systems Validation in a Regulated Environment

Jun 9, 2021
  • Quality & Regulatory
New Frontiers in Developing and Manufacturing Vaccines

New Frontiers in Developing and Manufacturing Vaccines

Jun 4, 2021
  • Biopharmaceuticals & Biotechnology
Early Career Professionals – Kickstart Your Career with PDA!

Early Career Professionals – Kickstart Your Career with PDA!

May 27, 2021
  • People
Call for Volunteers: The PDA Foundation

Call for Volunteers: The PDA Foundation

May 25, 2021
  • People
Modern Quality Professional, Part 2: The Case Studies

Modern Quality Professional, Part 2: The Case Studies

May 19, 2021
  • Quality & Regulatory
Flexibility—the Future of Manufacturing

Flexibility—the Future of Manufacturing

May 12, 2021
  • Manufacturing Science
Why Industry Cannot Just “Move Away" from the Dye Ingress Test

Why Industry Cannot Just “Move Away" from the Dye Ingress Test

May 5, 2021
  • Manufacturing Science
Pop Quiz: Which Academic Institutions should PDA Work With?

Pop Quiz: Which Academic Institutions should PDA Work With?

Apr 29, 2021
  • People
Remote Audits and Inspections May Be Here to Stay: PDA’s Task Force Aims to Help

Remote Audits and Inspections May Be Here to Stay: PDA’s Task Force Aims to Help

Apr 27, 2021
  • Quality & Regulatory
COVID-19 and the Sustainability of the LAL Supply

COVID-19 and the Sustainability of the LAL Supply

Apr 22, 2021
  • Manufacturing Science
Happenings at the 2021 PDA Singapore Chapter Annual General Meeting

Happenings at the 2021 PDA Singapore Chapter Annual General Meeting

Apr 13, 2021
  • People
The Modern Quality Professional Development Tool, Part 1

The Modern Quality Professional Development Tool, Part 1

Apr 8, 2021
  • Quality & Regulatory
The Two aspects of Visual Inspection: Process and Technology

The Two aspects of Visual Inspection: Process and Technology

Apr 1, 2021
  • Manufacturing Science
Nominations for PDA Board of Directors Accepted until May 10

Nominations for PDA Board of Directors Accepted until May 10

Mar 30, 2021
  • People
PDA in Print: Quality by Design— An Indispensable Approach to Accelerate Biopharmaceutical Product Development

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

Mar 25, 2021
  • Biopharmaceuticals & Biotechnology
  • Quality & Regulatory
PDA Annual Meeting and Honor Awards Ceremony Begins 75th Anniversary Celebration

PDA Annual Meeting and Honor Awards Ceremony Begins 75th Anniversary Celebration

Mar 23, 2021
  • People
The Role of Current GMPs in COVID-19 Vaccine Production

The Role of Current GMPs in COVID-19 Vaccine Production

Mar 17, 2021
  • Biopharmaceuticals & Biotechnology
  • Quality & Regulatory
In Print: PDA 2021 Post-Approval Change Issues and Impacts Survey

In Print: PDA 2021 Post-Approval Change Issues and Impacts Survey

Mar 11, 2021
Visual Inspection Training at PDA

Visual Inspection Training at PDA

Mar 9, 2021
  • Manufacturing Science
FDA Initiatives Drive 21st Century Advanced Manufacturing Technologies

FDA Initiatives Drive 21st Century Advanced Manufacturing Technologies

Mar 4, 2021
  • Manufacturing Science
SoCal Chapter Poster Finalist: Launching Drugs During COVID-19

SoCal Chapter Poster Finalist: Launching Drugs During COVID-19

Feb 26, 2021
  • Manufacturing Science
The Value of Membership

The Value of Membership

Feb 23, 2021
  • People
Think Big, Leverage and Cooperate to Get COVID-19 Vaccines to People Faster

Think Big, Leverage and Cooperate to Get COVID-19 Vaccines to People Faster

Feb 18, 2021
  • Supply Chain & Outsourcing
Supporting Early Career Professionals: How the Southern California Chapter Does It

Supporting Early Career Professionals: How the Southern California Chapter Does It

Feb 9, 2021
  • People
Parenteral Packaging 2021: A Q&A with Conference Chairs 

Parenteral Packaging 2021: A Q&A with Conference Chairs 

Feb 3, 2021
  • Supply Chain & Outsourcing
Voices of the Board: What has the year 2021 in store for us?

Voices of the Board: What has the year 2021 in store for us?

Jan 28, 2021
  • People
President’s Message: A Year Like No Other

President’s Message: A Year Like No Other

Jan 26, 2021
  • People
The Moldy Nightmare: Questions and Answers, Part 2

The Moldy Nightmare: Questions and Answers, Part 2

Jan 20, 2021
  • Aseptic Processing & Sterilization
Accelerating Biopharmaceutical Innovation in Health Emergencies

Accelerating Biopharmaceutical Innovation in Health Emergencies

Jan 15, 2021
  • Biopharmaceuticals & Biotechnology
A Unique Year of Hidden Treasures

A Unique Year of Hidden Treasures

Jan 8, 2021
  • People
The Moldy Nightmare: Questions and Answers, Part 1

The Moldy Nightmare: Questions and Answers, Part 1

Jan 6, 2021
  • Aseptic Processing & Sterilization
Facilitating Continual Improvement, Innovation, and Reducing Drug Shortages through Enhanced Science and Risk-based PACs

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

Dec 17, 2020
  • Quality & Regulatory
ANNEX 1 Revision Task Force Update

ANNEX 1 Revision Task Force Update

Dec 15, 2020
  • Aseptic Processing & Sterilization
  • Quality & Regulatory
Think Globally, Work Virtually in the Era of COVID-19: The Future of Biotech Success

Think Globally, Work Virtually in the Era of COVID-19: The Future of Biotech Success

Dec 10, 2020
  • Biopharmaceuticals & Biotechnology
Getting Closer to AI Adoption in the Pharmaceutical Industry

Getting Closer to AI Adoption in the Pharmaceutical Industry

Dec 8, 2020
  • Manufacturing Science
Publishing by the Numbers: An End of an Era

Publishing by the Numbers: An End of an Era

Dec 4, 2020
  • People
Worried about the availability of primary packaging for the COVID Vaccine? It’s a logistics challenge, not a supply challenge

Worried about the availability of primary packaging for the COVID Vaccine? It’s a logistics challenge, not a supply challenge

Dec 2, 2020
  • Supply Chain & Outsourcing
5 Steps of Design Thinking

5 Steps of Design Thinking

Nov 19, 2020
  • Quality & Regulatory
Continued Process Verification: Reacting to Data Signals

Continued Process Verification: Reacting to Data Signals

Nov 18, 2020
  • Manufacturing Science
Keeping Biopharma’s Essential Services Lifeline Afloat during COVID

Keeping Biopharma’s Essential Services Lifeline Afloat during COVID

Nov 11, 2020
  • Supply Chain & Outsourcing
Injectable Combination Product Integrated Development: A PDA Live eLearning Course

Injectable Combination Product Integrated Development: A PDA Live eLearning Course

Nov 5, 2020
  • Manufacturing Science
Call for Volunteers: New PDA Standard on Biologics Validation/QC

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

Nov 3, 2020
  • Biopharmaceuticals & Biotechnology
  • Quality & Regulatory
  • People
Virtual Audits in the Time of COVID-19: For the Auditor and the Host

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

Oct 28, 2020
  • Quality & Regulatory
Utilizing Modeling in Manufacturing

Utilizing Modeling in Manufacturing

Oct 23, 2020
  • Manufacturing Science

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