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  • Quality & Regulatory

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

  • Walter Morris, PDA, Inc.
  • Dec 3, 2021
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  • Manufacturing Science
  • Aseptic Processing & Sterilization

Contamination Control Strategies: You have questions, we have answers

  • Rafael Beaus, PhD, Azbil Telstar, James N. Polarine, STERIS Corporation, and Benoit Ramond, PhD, Sanofi
  • Nov 17, 2021
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  • Manufacturing Science

Thanks, Science!

  • Marilyn L. Foster, PDA
  • Nov 3, 2021
  • Article Categories
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
Get Published And Noticed!

Get Published And Noticed!

Oct 20, 2020
  • People
The Product Quality Research Institute – Advancing Regulatory Science through Collaboration

The Product Quality Research Institute – Advancing Regulatory Science through Collaboration

Oct 14, 2020
  • Quality & Regulatory
Fifth Annual Women in Life Science Panel Discussion

Fifth Annual Women in Life Science Panel Discussion

Oct 8, 2020
  • People
Data Analytics in Pharmaceutical Manufacturing

Data Analytics in Pharmaceutical Manufacturing

Oct 6, 2020
  • Manufacturing Science
Chemical Durability Ratio: Method Provides Leading Indicator of Delamination Risk

Chemical Durability Ratio: Method Provides Leading Indicator of Delamination Risk

Oct 2, 2020
  • Manufacturing Science
Success Stories: RMM Implementation in the 21st Century

Success Stories: RMM Implementation in the 21st Century

Sep 30, 2020
  • Manufacturing Science
  • Aseptic Processing & Sterilization
Joint Associations’ Response Letter on EU Annex 1 Draft

Joint Associations’ Response Letter on EU Annex 1 Draft

Sep 24, 2020
  • Aseptic Processing & Sterilization
  • Quality & Regulatory
PDA Requests Pause to USP’s Biologics Nomenclature Proposal

PDA Requests Pause to USP’s Biologics Nomenclature Proposal

Sep 22, 2020
  • Quality & Regulatory
T-Cell Therapy Saves a Life

T-Cell Therapy Saves a Life

Sep 17, 2020
  • Biopharmaceuticals & Biotechnology
We Want You! ATMP Advisory Board Seeks Volunteers

We Want You! ATMP Advisory Board Seeks Volunteers

Sep 16, 2020
  • People
  • Biopharmaceuticals & Biotechnology
2020 PDA Pharmacopeia Conference

2020 PDA Pharmacopeia Conference

Sep 15, 2020
  • Quality & Regulatory
Missouri Valley Chapter Donates to Local Hospitals

Missouri Valley Chapter Donates to Local Hospitals

Sep 9, 2020
  • People
PDA Survey Results: Current State of Cryopreservation

PDA Survey Results: Current State of Cryopreservation

Sep 3, 2020
  • Biopharmaceuticals & Biotechnology
FDA Shares Views on ICH Q12, Continuous Improvement and Innovation

FDA Shares Views on ICH Q12, Continuous Improvement and Innovation

Aug 26, 2020
  • Quality & Regulatory
Volunteers Needed: Event Reporters

Volunteers Needed: Event Reporters

Aug 25, 2020
  • People
The House of Data Integrity Compliance

The House of Data Integrity Compliance

Aug 20, 2020
  • Quality & Regulatory
Six Q & A’s about Innovation in the Medical Device Industry

Six Q & A’s about Innovation in the Medical Device Industry

Aug 18, 2020
  • Manufacturing Science
The Evolution of USP <800>: A Q&A with Cathy Zhao and Allison Radwick

The Evolution of USP <800>: A Q&A with Cathy Zhao and Allison Radwick

Aug 13, 2020
  • Manufacturing Science
Data Integrity: The New World of Virtual Audits and Investigations

Data Integrity: The New World of Virtual Audits and Investigations

Aug 6, 2020
  • Quality & Regulatory
PDA IG Explores Next-Gen Sequencing for Viruses

PDA IG Explores Next-Gen Sequencing for Viruses

Aug 3, 2020
  • Biopharmaceuticals & Biotechnology
SoCal Chapter Donates Masks to Aid Service Providers

SoCal Chapter Donates Masks to Aid Service Providers

Jul 28, 2020
  • People
Best Practice Guide for Using KPI’s/Metrics

Best Practice Guide for Using KPI’s/Metrics

Jul 22, 2020
  • Quality & Regulatory
Global Regulatory Convergence Required to Expand Access to ATMPs

Global Regulatory Convergence Required to Expand Access to ATMPs

Jul 16, 2020
  • Biopharmaceuticals & Biotechnology
CBER Continues to Analyze Next-Gen Sequencing

CBER Continues to Analyze Next-Gen Sequencing

Jul 9, 2020
  • Biopharmaceuticals & Biotechnology

A Fond Farewell to Readers

Jul 9, 2020
  • People

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