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  • Aseptic Processing & Sterilization
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Opinion: Revisit Regulatory Expectations for Micro ID in Grade A Environments for Non-growth-based Methods?

  • Petra Merker, PhD, Bayer AG, Tony Cundell, PhD, Microbiological Consulting, LLC, and Cynthia Martindale, Applied Rapid Microbiology Specialists, Ltd.
  • Nov 25, 2023
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  • Quality & Regulatory

Building an Effective Data Integrity Program Using Risk Management

  • Chinmoy Roy, PDA, Inc.
  • Nov 1, 2023
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  • Aseptic Processing & Sterilization
  • Quality & Regulatory

Reducing Human Error for Manual Visual Inspection

  • Vanessa Vasadi Figueroa, QxP and VVF Science, and Robert Ferer, QxP
  • Oct 26, 2023
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On The Issue: 2023 PDA Drug Delivery Innovation Award

On The Issue: 2023 PDA Drug Delivery Innovation Award

Nov 30, 2023
  • People
On The Issue: The Digitalization IG & Task Force

On The Issue: The Digitalization IG & Task Force

Nov 28, 2023
  • People
Opinion: Revisit Regulatory Expectations for Micro ID in Grade A Environments for Non-growth-based Methods?

Opinion: Revisit Regulatory Expectations for Micro ID in Grade A Environments for Non-growth-based Methods?

Nov 25, 2023
  • Aseptic Processing & Sterilization
  • Biopharmaceuticals & Biotechnology
PDA Microbiology Conference 2022 Presentation: Answers You Have Been Wanting

PDA Microbiology Conference 2022 Presentation: Answers You Have Been Wanting

Nov 21, 2023
  • People
  • Aseptic Processing & Sterilization
PDA Spotlight Podcast Episode 2: Board of Directors Series

PDA Spotlight Podcast Episode 2: Board of Directors Series

Nov 15, 2023
  • People
In Memoriam: Immediate-Past Chair Jette Christensen

In Memoriam: Immediate-Past Chair Jette Christensen

Nov 13, 2023
  • People
Challenges of Analytical Method Validation for ATMPs

Challenges of Analytical Method Validation for ATMPs

Nov 9, 2023
  • Quality & Regulatory
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Change for Good, Be a Disrupter!

Change for Good, Be a Disrupter!

Nov 8, 2023
  • People
Taking a Data-Centric Approach to Computer Systems Validation

Taking a Data-Centric Approach to Computer Systems Validation

Nov 7, 2023
  • Quality & Regulatory
Building an Effective Data Integrity Program Using Risk Management

Building an Effective Data Integrity Program Using Risk Management

Nov 1, 2023
  • Quality & Regulatory
On The Issue: 2022 PDA Partnership Innovation Award

On The Issue: 2022 PDA Partnership Innovation Award

Oct 31, 2023
  • People
Reducing Human Error for Manual Visual Inspection

Reducing Human Error for Manual Visual Inspection

Oct 26, 2023
  • Aseptic Processing & Sterilization
  • Quality & Regulatory
Continuing the Conversation for Better ATMP Development

Continuing the Conversation for Better ATMP Development

Oct 25, 2023
  • Quality & Regulatory
  • Biopharmaceuticals & Biotechnology
Balancing Act: Human vs. Machine Inspection in Pharmaceutical Manufacturing

Balancing Act: Human vs. Machine Inspection in Pharmaceutical Manufacturing

Oct 18, 2023
  • Aseptic Processing & Sterilization
  • Manufacturing Science
PDA Spotlight Podcast Episode 1: Board of Directors Series

PDA Spotlight Podcast Episode 1: Board of Directors Series

Oct 17, 2023
PDA and FDA Continues Collaboration on QMM Conversation

PDA and FDA Continues Collaboration on QMM Conversation

Oct 12, 2023
  • Quality & Regulatory
Aligning Global Regulatory Guidance Documents for Container Closure Integrity

Aligning Global Regulatory Guidance Documents for Container Closure Integrity

Oct 11, 2023
  • Aseptic Processing & Sterilization
  • Quality & Regulatory
2023 PDA Quality & Regulations Conference

2023 PDA Quality & Regulations Conference

Oct 10, 2023
  • Supply Chain & Outsourcing
  • People
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The Importance of Visual Inspection in Injection of Parenteral Drug Products

The Importance of Visual Inspection in Injection of Parenteral Drug Products

Oct 4, 2023
  • Aseptic Processing & Sterilization
Welcome New RAQAB Members

Welcome New RAQAB Members

Sep 28, 2023
  • People
The European Ban on PFASs

The European Ban on PFASs

Sep 27, 2023
  • Biopharmaceuticals & Biotechnology
Testing of the Future

Testing of the Future

Sep 21, 2023
  • Science
  • Supply Chain & Outsourcing
  • People
Microbiologists and Training: A Crucial Quality Connection

Microbiologists and Training: A Crucial Quality Connection

Sep 20, 2023
  • Science
  • Quality & Regulatory
  • People
In-Situ Verification of Disinfectant Rotation for Contamination Control

In-Situ Verification of Disinfectant Rotation for Contamination Control

Sep 19, 2023
  • Science
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  • Aseptic Processing & Sterilization
Time to Start Using Polypropylene Vials in the Industry

Time to Start Using Polypropylene Vials in the Industry

Sep 13, 2023
  • Aseptic Processing & Sterilization
  • Manufacturing Science
The Difficult Task of Solving Contamination Puzzles

The Difficult Task of Solving Contamination Puzzles

Sep 7, 2023
  • Quality & Regulatory
  • Aseptic Processing & Sterilization
Artificial Intelligence and Machine Learning in the Early Stage of a Product Life Cycle

Artificial Intelligence and Machine Learning in the Early Stage of a Product Life Cycle

Sep 6, 2023
  • Quality & Regulatory
  • Manufacturing Science
Seven Key Takeaways from PDA’s Good Aseptic Manufacturing Conference

Seven Key Takeaways from PDA’s Good Aseptic Manufacturing Conference

Aug 31, 2023
  • Aseptic Processing & Sterilization
Per- and Polyfluoroalkyl Substances Ban Starting 2027

Per- and Polyfluoroalkyl Substances Ban Starting 2027

Aug 29, 2023
  • Biopharmaceuticals & Biotechnology
  • Quality & Regulatory
  • People
Quality Culture Post-Pandemic

Quality Culture Post-Pandemic

Aug 24, 2023
  • Quality & Regulatory
On The Issue: Digitalization of C.C.

On The Issue: Digitalization of C.C.

Aug 22, 2023
  • Aseptic Processing & Sterilization
2022 PDA Honor Awards: Honorary Membership

2022 PDA Honor Awards: Honorary Membership

Aug 15, 2023
  • People
Macro Impacts from the Micro-Universe

Macro Impacts from the Micro-Universe

Aug 10, 2023
  • Quality & Regulatory
  • Biopharmaceuticals & Biotechnology
  • People
The 2023 PDA BioManufacturing Conference Lands in Seville, Spain

The 2023 PDA BioManufacturing Conference Lands in Seville, Spain

Aug 9, 2023
  • Quality & Regulatory
  • People
  • Biopharmaceuticals & Biotechnology
2022 PDA Honor Awards: James Agalloco, Gordon Personeus, and Frederick Carleton Awards

2022 PDA Honor Awards: James Agalloco, Gordon Personeus, and Frederick Carleton Awards

Aug 8, 2023
  • People
In-process Microbial Control During Aseptic Processing – Medium Risk

In-process Microbial Control During Aseptic Processing – Medium Risk

Aug 2, 2023
  • Aseptic Processing & Sterilization
Respond to Survey on ECHA Proposed PFAS Restrictions by Aug. 4

Respond to Survey on ECHA Proposed PFAS Restrictions by Aug. 4

Jul 27, 2023
  • Science
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Maintaining Compliance with Deviation Reports: A Glimpse into the 2023 PDA Mastering Deviations Workshop

Maintaining Compliance with Deviation Reports: A Glimpse into the 2023 PDA Mastering Deviations Workshop

Jul 26, 2023
  • People
  • Quality & Regulatory
2022 PDA Honor Awards: PDA President’s Award

2022 PDA Honor Awards: PDA President’s Award

Jul 25, 2023
  • People
An Uncommon Battle: Living with Chronic Intestinal Pseudo-Obstruction

An Uncommon Battle: Living with Chronic Intestinal Pseudo-Obstruction

Jul 19, 2023
  • People
Making The Most of External Signals for Internal Learning and Knowledge Management

Making The Most of External Signals for Internal Learning and Knowledge Management

Jul 13, 2023
  • People
  • Quality & Regulatory
In Memoriam: Amit Sharma

In Memoriam: Amit Sharma

Jul 12, 2023
  • People
2022 PDA Honor Awards: PDA Publications

2022 PDA Honor Awards: PDA Publications

Jul 11, 2023
  • People
In-process Microbial Control During Aseptic Processing (High-Risk)

In-process Microbial Control During Aseptic Processing (High-Risk)

Jul 5, 2023
  • Aseptic Processing & Sterilization
  • Manufacturing Science
On the Issue: The PDA/FDA Joint Regulatory Conference

On the Issue: The PDA/FDA Joint Regulatory Conference

Jun 29, 2023
  • People
2023 PDA Particle Control in Biopharmaceuticals

2023 PDA Particle Control in Biopharmaceuticals

Jun 28, 2023
  • Quality & Regulatory
  • People
  • Biopharmaceuticals & Biotechnology
2022 PDA Honor Awards: EU, PDA Asia/Pacific Appreciation, and Chapter of the Year Awards

2022 PDA Honor Awards: EU, PDA Asia/Pacific Appreciation, and Chapter of the Year Awards

Jun 27, 2023
  • People
From Risk Assessment to Employee Training

From Risk Assessment to Employee Training

Jun 21, 2023
  • Quality & Regulatory
  • Manufacturing Science
2022 Honor Awards: Outstanding Early Career Professional Award

2022 Honor Awards: Outstanding Early Career Professional Award

Jun 15, 2023
  • People
On the Issue: The 2022 PDA Micro Conference Co-Chairs

On the Issue: The 2022 PDA Micro Conference Co-Chairs

Jun 14, 2023
  • People
Impactful Pharma Career Day at PSB City Campus

Impactful Pharma Career Day at PSB City Campus

Jun 13, 2023
  • People
In Memoriam: Joyce Bloomfield

In Memoriam: Joyce Bloomfield

Jun 12, 2023
  • People
Cybersecurity and Its Growing Impact on Medical Devices

Cybersecurity and Its Growing Impact on Medical Devices

Jun 7, 2023
  • Quality & Regulatory
  • Manufacturing Science
On The Issue: Data Integrity with Kir Henrici

On The Issue: Data Integrity with Kir Henrici

May 31, 2023
  • People
2022 PDA Honor Awards: VanTrieste, Korczynski and Smith Awards

2022 PDA Honor Awards: VanTrieste, Korczynski and Smith Awards

May 30, 2023
  • People
How to Establish Effective CCS With TR-90

How to Establish Effective CCS With TR-90

May 25, 2023
  • Quality & Regulatory
  • Aseptic Processing & Sterilization
Achieving Top Management’s Interest Through the Use of KPIs and QPIs

Achieving Top Management’s Interest Through the Use of KPIs and QPIs

May 17, 2023
  • Quality & Regulatory
Closing the Distance on the Plastics Supply Chain

Closing the Distance on the Plastics Supply Chain

May 11, 2023
  • Manufacturing Science
  • People
2022 PDA Honor Awards: Distinguished Service Awards

2022 PDA Honor Awards: Distinguished Service Awards

May 9, 2023
  • People
2023 PDA Universe of Pre-Filled Syringes and Injection Devices Conference!

2023 PDA Universe of Pre-Filled Syringes and Injection Devices Conference!

May 3, 2023
  • Manufacturing Science
  • Quality & Regulatory
2022 PDA Honor Awards: Service Appreciation Award

2022 PDA Honor Awards: Service Appreciation Award

Apr 27, 2023
  • People
On the Issue: Philippe Germanaud, Part 3

On the Issue: Philippe Germanaud, Part 3

Apr 26, 2023
  • People
Industry Remains Divided on Quality Management Maturity Proposal

Industry Remains Divided on Quality Management Maturity Proposal

Apr 25, 2023
  • People
  • Quality & Regulatory
The Evolution of Cleaning and Disinfection Practices Over 20 Years

The Evolution of Cleaning and Disinfection Practices Over 20 Years

Apr 19, 2023
  • Science
  • Aseptic Processing & Sterilization
  • Regulatory
2022 PDA Letter Article of the Year

2022 PDA Letter Article of the Year

Apr 13, 2023
  • People
Nominations for PDA Board of Directors Accepted until May 8

Nominations for PDA Board of Directors Accepted until May 8

Apr 12, 2023
  • People
Are Your Drug or Device Endotoxins Up to Specs?

Are Your Drug or Device Endotoxins Up to Specs?

Apr 11, 2023
  • Manufacturing Science
  • Quality & Regulatory
Understanding Disinfectant Efficacy for Off-Label Microorganisms

Understanding Disinfectant Efficacy for Off-Label Microorganisms

Apr 5, 2023
  • Science
  • Regulatory
  • Aseptic Processing & Sterilization
On The Issue: Former Sanofi CQO Philippe Germanaud Part 2

On The Issue: Former Sanofi CQO Philippe Germanaud Part 2

Mar 29, 2023
  • People
Vaccine Development Discussion at PDA Europe Biomanufacturing Conference

Vaccine Development Discussion at PDA Europe Biomanufacturing Conference

Mar 23, 2023
  • Biopharmaceuticals & Biotechnology
  • Quality & Regulatory
  • Manufacturing Science
The Urgency for Robotization and Automation

The Urgency for Robotization and Automation

Mar 22, 2023
  • Quality & Regulatory
  • Manufacturing Science
You’re Invited to the 2023 PDA Virus Conference

You’re Invited to the 2023 PDA Virus Conference

Mar 16, 2023
  • Manufacturing Science
  • Quality & Regulatory
  • People
Don’t Miss the 2023 PDA Good Aseptic Manufacturing Conference!

Don’t Miss the 2023 PDA Good Aseptic Manufacturing Conference!

Mar 15, 2023
  • Aseptic Processing & Sterilization
Join Us at the 2023 Visual Inspection Forum

Join Us at the 2023 Visual Inspection Forum

Mar 9, 2023
  • Aseptic Processing & Sterilization
  • Manufacturing Science
  • People
Robotics and Automation in Pharmaceutical Production

Robotics and Automation in Pharmaceutical Production

Mar 7, 2023
  • Quality & Regulatory
  • Manufacturing Science
Making Connections to Last a Lifetime

Making Connections to Last a Lifetime

Feb 28, 2023
  • People
We

We're Going to New Orleans! Let’s Talk about Contamination Control and the Annex 1 Revision

Feb 23, 2023
  • Quality & Regulatory
  • People
Let the Good Times Roll in New Orleans!

Let the Good Times Roll in New Orleans!

Feb 16, 2023
  • People
On The Issue: Philippe Germanaud

On The Issue: Philippe Germanaud

Feb 14, 2023
  • People
  • Science
Learning from the Past in A Patient-Centric World

Learning from the Past in A Patient-Centric World

Feb 9, 2023
  • People
Key Takeaways from the 2022 PDA Annex 1 Workshop in Dublin

Key Takeaways from the 2022 PDA Annex 1 Workshop in Dublin

Feb 7, 2023
  • Aseptic Processing & Sterilization
  • Quality & Regulatory
Joint Regulatory Conference: Bringing Better Innovation and Communication Moving Forward

Joint Regulatory Conference: Bringing Better Innovation and Communication Moving Forward

Feb 1, 2023
  • Quality & Regulatory
Upcoming CCS Workshop — A New Direction in Workshop Design

Upcoming CCS Workshop — A New Direction in Workshop Design

Jan 31, 2023
  • Quality & Regulatory
  • Manufacturing Science
President’s Message: A Bittersweet Farewell

President’s Message: A Bittersweet Farewell

Jan 26, 2023
  • People
The Complex Process for Sterile Filling and Points to Consider

The Complex Process for Sterile Filling and Points to Consider

Jan 25, 2023
  • Aseptic Processing & Sterilization
  • Quality & Regulatory
ATMPs and Annex 1: Some Answers, but More Questions

ATMPs and Annex 1: Some Answers, but More Questions

Jan 18, 2023
  • Biopharmaceuticals & Biotechnology
Hello PDA! A Formal Introduction to the PDA Letter

Hello PDA! A Formal Introduction to the PDA Letter

Jan 13, 2023
  • People
Are You Ready for Sustainable Packaging?

Are You Ready for Sustainable Packaging?

Jan 12, 2023
  • Manufacturing Science
Chair’s Message: A New Horizon for Our PDA Members around the World

Chair’s Message: A New Horizon for Our PDA Members around the World

Jan 11, 2023
  • People
Putting AI to the Test with Continued Process Verification

Putting AI to the Test with Continued Process Verification

Jan 4, 2023
  • Quality & Regulatory
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Modernizing Risk Assessment for Legacy Products

Modernizing Risk Assessment for Legacy Products

Dec 15, 2022
  • Quality & Regulatory
Spotlight on PDA Education in India

Spotlight on PDA Education in India

Dec 8, 2022
  • People
  • Manufacturing Science
Turning Annual Product Quality Reviews into a Strategic Advantage

Turning Annual Product Quality Reviews into a Strategic Advantage

Nov 30, 2022
  • Quality & Regulatory
PDA SoCal Chapter Two-Year Update

PDA SoCal Chapter Two-Year Update

Nov 17, 2022
  • People
On The Issue: Next Gen ATMP Production

On The Issue: Next Gen ATMP Production

Nov 15, 2022
  • Manufacturing Science
  • Biopharmaceuticals & Biotechnology
PDA Annex 1 Workshop: Six Key Takeaways from the Final Annex 1

PDA Annex 1 Workshop: Six Key Takeaways from the Final Annex 1

Nov 9, 2022
  • Quality & Regulatory
  • Aseptic Processing & Sterilization
Technological Solutions to Overcome the New Annex 1 Challenges

Technological Solutions to Overcome the New Annex 1 Challenges

Nov 3, 2022
  • Aseptic Processing & Sterilization
  • Quality & Regulatory
Microbial Control of Raw Materials Used in Pharmaceuticals

Microbial Control of Raw Materials Used in Pharmaceuticals

Oct 26, 2022
  • Quality & Regulatory
  • Aseptic Processing & Sterilization
On The Issue: The Future of Batch Records

On The Issue: The Future of Batch Records

Oct 20, 2022
  • Manufacturing Science
PDA Announces 2022 Drug Delivery Innovation Awards Winners

PDA Announces 2022 Drug Delivery Innovation Awards Winners

Oct 19, 2022
  • Manufacturing Science

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