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  • Aseptic Processing & Sterilization
  • Biopharmaceuticals & Biotechnology

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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Missouri Valley Chapter Dinner Taps Inspections/Annex 1

Missouri Valley Chapter Dinner Taps Inspections/Annex 1

Oct 18, 2022
  • Quality & Regulatory
  • Aseptic Processing & Sterilization
Look Both Ways Before Hiring

Look Both Ways Before Hiring

Oct 13, 2022
  • People
Voice of the Board: Election for Board of Directors — It is time for you to vote!

Voice of the Board: Election for Board of Directors — It is time for you to vote!

Oct 6, 2022
  • People
On The Issue: The 2022 PDA ATMP Conference

On The Issue: The 2022 PDA ATMP Conference

Oct 4, 2022
  • Manufacturing Science
Digital Transformation without the Transformation

Digital Transformation without the Transformation

Sep 28, 2022
  • Manufacturing Science
2021 PDA Honor Awards: Honorary Membership

2021 PDA Honor Awards: Honorary Membership

Sep 27, 2022
  • People
Advancing the State of the Art & Transforming Innovation into Practice

Advancing the State of the Art & Transforming Innovation into Practice

Sep 22, 2022
  • Manufacturing Science
On The Issue: Next Gen Sequencing

On The Issue: Next Gen Sequencing

Sep 21, 2022
  • Manufacturing Science
  • Biopharmaceuticals & Biotechnology
2021 PDA Honor Awards: James Agalloco, Gordon Personeus, and Frederick Carleton Awards

2021 PDA Honor Awards: James Agalloco, Gordon Personeus, and Frederick Carleton Awards

Sep 16, 2022
  • People
2022 PDA Quality & Regulations Conference

2022 PDA Quality & Regulations Conference

Sep 12, 2022
  • Quality & Regulatory
GMP Challenges with Time Limitations in Pharma Manufacturing

GMP Challenges with Time Limitations in Pharma Manufacturing

Sep 8, 2022
  • Manufacturing Science
  • Quality & Regulatory
On the Issue: The PDA Virus Conference Chairs

On the Issue: The PDA Virus Conference Chairs

Sep 1, 2022
  • Biopharmaceuticals & Biotechnology
2022 Universe of Pre-Filled Syringes and Injection Devices Conference

2022 Universe of Pre-Filled Syringes and Injection Devices Conference

Aug 31, 2022
  • Manufacturing Science
Understanding the “Halo Effect” and Its Impact on You Right Now

Understanding the “Halo Effect” and Its Impact on You Right Now

Aug 30, 2022
  • People
PDA Midwest Chapter’s Parametric Release Event – A Call to Action

PDA Midwest Chapter’s Parametric Release Event – A Call to Action

Aug 25, 2022
  • Aseptic Processing & Sterilization
2021 PDA Honor Awards: PDA President’s Award

2021 PDA Honor Awards: PDA President’s Award

Aug 24, 2022
  • People
On the Issue: PDA Technical Report No. 41 Revised

On the Issue: PDA Technical Report No. 41 Revised

Aug 18, 2022
  • Biopharmaceuticals & Biotechnology
Investigating Out-of-Specification Results for BET

Investigating Out-of-Specification Results for BET

Aug 17, 2022
  • Quality & Regulatory
  • Aseptic Processing & Sterilization
2022 PDA BioManufacturing Conference Lands in Amsterdam

2022 PDA BioManufacturing Conference Lands in Amsterdam

Aug 10, 2022
  • Biopharmaceuticals & Biotechnology
2021 PDA Honor Awards: PDA Publications

2021 PDA Honor Awards: PDA Publications

Aug 9, 2022
  • People
Key Takeaways from the PDA Annex 1 Workshop

Key Takeaways from the PDA Annex 1 Workshop

Aug 4, 2022
  • Quality & Regulatory
2021 PDA Honor Awards: EU, PDA Asia/Pacific Appreciation, and Chapter of the Year Awards

2021 PDA Honor Awards: EU, PDA Asia/Pacific Appreciation, and Chapter of the Year Awards

Jul 28, 2022
  • People
TR-41: The 2022 Revision

TR-41: The 2022 Revision

Jul 26, 2022
  • Biopharmaceuticals & Biotechnology
Highlights of the SBIA Generic Drugs Forum

Highlights of the SBIA Generic Drugs Forum

Jul 20, 2022
  • Quality & Regulatory
PDA Launches New Tiered Membership Structure

PDA Launches New Tiered Membership Structure

Jul 15, 2022
  • People
2021 PDA Honor Awards: Outstanding Early Career Professional Award​

2021 PDA Honor Awards: Outstanding Early Career Professional Award​

Jul 12, 2022
  • People
A Successful Q-Model for New mRNA Line Commissioning & Qualification: Pt. 2

A Successful Q-Model for New mRNA Line Commissioning & Qualification: Pt. 2

Jul 7, 2022
  • Biopharmaceuticals & Biotechnology
  • Quality & Regulatory
Voices of the Board: PDA Technical Pubs

Voices of the Board: PDA Technical Pubs

Jun 30, 2022
  • Manufacturing Science
2021 PDA Honor Awards: Service Appreciation Award

2021 PDA Honor Awards: Service Appreciation Award

Jun 28, 2022
  • People
Summer Reading: Grab a PDA Book & Leave Your Troubles Behind

Summer Reading: Grab a PDA Book & Leave Your Troubles Behind

Jun 22, 2022
  • People
PDA BioManufacturing and Lyophilization Conferences: The Start of a Shared Journey

PDA BioManufacturing and Lyophilization Conferences: The Start of a Shared Journey

Jun 15, 2022
  • Quality & Regulatory
  • Biopharmaceuticals & Biotechnology
Death by Data Integrity Assessment

Death by Data Integrity Assessment

Jun 9, 2022
  • Quality & Regulatory
2021 PDA Honor Awards: Distinguished Service Awards

2021 PDA Honor Awards: Distinguished Service Awards

Jun 8, 2022
  • People
A Successful Q-Model for New mRNA Line Commissioning & Qualification: Pt. 1

A Successful Q-Model for New mRNA Line Commissioning & Qualification: Pt. 1

Jun 1, 2022
  • Biopharmaceuticals & Biotechnology
  • Quality & Regulatory
One Reason I am Happy to Write a Recommendation Letter

One Reason I am Happy to Write a Recommendation Letter

May 25, 2022
  • People
Contamination Control Strategies: A Path for Quality & Safety

Contamination Control Strategies: A Path for Quality & Safety

May 18, 2022
  • Aseptic Processing & Sterilization
2021 PDA Honor Awards: VanTrieste, Korczynski and Smith Awards

2021 PDA Honor Awards: VanTrieste, Korczynski and 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
Accelerated COVAX Approvals Maintained Rigorous Review Process

Accelerated COVAX Approvals Maintained Rigorous Review Process

Apr 26, 2022
  • Biopharmaceuticals & Biotechnology
  • Quality & Regulatory
Merck Streamlines Quality Management with the Cloud

Merck Streamlines Quality Management with the Cloud

Apr 20, 2022
  • Quality & Regulatory
Glenn E. Wright Starts as PDA President & CEO in March 2023; Richard M. Johnson to Retire

Glenn E. Wright Starts as PDA President & CEO in March 2023; Richard M. Johnson to Retire

Apr 14, 2022
  • People
PDA

PDA's Successful Return to In-Person Meetings

Apr 12, 2022
  • People
Initial Evaluation Roadmap for Modern Microbial Methods

Initial Evaluation Roadmap for Modern Microbial Methods

Apr 6, 2022
  • Manufacturing Science
Voices of the Board: The PDA Foundation

Voices of the Board: The PDA Foundation

Mar 29, 2022
  • People
PDA is Updating Its Membership Structure!

PDA is Updating Its Membership Structure!

Mar 24, 2022
  • People
Rich Levy Retires; Shanker Gupta to serve as Acting JPST Editor

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

Mar 22, 2022
  • People
How Ergonomics & Cleaning Reduce Injuries, Contamination in Micro QC Workflows

How Ergonomics & Cleaning Reduce Injuries, Contamination in Micro QC Workflows

Mar 16, 2022
  • Manufacturing Science
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

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