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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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Singapore Chapter Elects New Board via Electronic Voting

Singapore Chapter Elects New Board via Electronic Voting

Apr 16, 2020
  • People
More Online Content to Help Pharma

More Online Content to Help Pharma

Apr 15, 2020
  • People
Visual Inspection Practices of Cleaned Equipment: Part I

Visual Inspection Practices of Cleaned Equipment: Part I

Apr 14, 2020
  • Aseptic Processing & Sterilization
The Product Quality Leader Team Part III: Staying Ahead

The Product Quality Leader Team Part III: Staying Ahead

Apr 9, 2020
  • Biopharmaceuticals & Biotechnology
CMO Works Around the Clock to Produce COVID-19 Meds

CMO Works Around the Clock to Produce COVID-19 Meds

Apr 8, 2020
  • Aseptic Processing & Sterilization
Connect with Colleagues via PDA

Connect with Colleagues via PDA

Apr 8, 2020
  • People
PDA Study Explores Role of A.I. in CPV

PDA Study Explores Role of A.I. in CPV

Apr 7, 2020
  • Manufacturing Science
Guest Editorial: A Report on the COVID-19 Situation in India

Guest Editorial: A Report on the COVID-19 Situation in India

Apr 3, 2020
  • Quality & Regulatory
PDA Members Recommend ICH Q9 Changes

PDA Members Recommend ICH Q9 Changes

Apr 2, 2020
  • Quality & Regulatory

Task Group Formed to Craft PDA Quality Culture Standard

Mar 31, 2020
  • Quality & Regulatory
Guest Editorial: We Should Expect Drug Shortages to Get Worse

Guest Editorial: We Should Expect Drug Shortages to Get Worse

Mar 27, 2020
  • Supply Chain & Outsourcing
Real-World Applications of Rapid Micro Methods

Real-World Applications of Rapid Micro Methods

Mar 26, 2020
  • Aseptic Processing & Sterilization
Cryogenic Storage Challenges for Container-Closure Systems

Cryogenic Storage Challenges for Container-Closure Systems

Mar 25, 2020
  • Biopharmaceuticals & Biotechnology

Sterility Test Failure Investigations

Mar 24, 2020
  • Aseptic Processing & Sterilization
9 Tips to Make Working Remotely Work for You and Your Employer

9 Tips to Make Working Remotely Work for You and Your Employer

Mar 24, 2020
  • People
Qualification of Manual Visual Inspection Still Critical

Qualification of Manual Visual Inspection Still Critical

Mar 19, 2020
  • Manufacturing Science

New Look for the PDA Letter! Plus, All New Content Unlocked

Mar 18, 2020
  • People

The Product Quality Leader Team Part II: Getting Ahead

Mar 17, 2020
  • Biopharmaceuticals & Biotechnology

Moving Beyond “Grande-Sized” Manufacturing for Gene Therapies

Mar 12, 2020
  • Biopharmaceuticals & Biotechnology

PDA Responds to the Novel Coronavirus Situation

Mar 11, 2020
  • People

Tools to Address Human Error Reduction

Mar 11, 2020
  • People

40 Years of Visual Inspection: Where Do We Go from Here?

Mar 5, 2020
  • Manufacturing Science
Inaugural BioManufacturing Conference Tackles Five Key Issues: Part II

Inaugural BioManufacturing Conference Tackles Five Key Issues: Part II

Mar 3, 2020
  • Biopharmaceuticals & Biotechnology

Data Integrity: From the Basics to Big Data

Feb 27, 2020
  • Quality & Regulatory

Innovations in Aseptic Processing

Feb 25, 2020
  • Aseptic Processing & Sterilization

Annex 1 to VPHP: The ABCs of Aseptic Processing

Feb 20, 2020
  • People
Inaugural BioManufacturing Conference Tackles Five Key Issues: Part I

Inaugural BioManufacturing Conference Tackles Five Key Issues: Part I

Feb 18, 2020
  • Biopharmaceuticals & Biotechnology

Board of Directors Nominations Needed 

Feb 13, 2020
  • People
Members Only Content

New Decade, New Focus for PDA Letter

Feb 13, 2020
  • People

Female Biotech Leaders Discuss Their Career Journeys, Offer Advice

Feb 11, 2020
  • People

5.0 Ways Quality 4.0 Will Improve Manufacturing

Feb 6, 2020
  • Quality & Regulatory
Could A.I. Optimize Visual Inspection?

Could A.I. Optimize Visual Inspection?

Feb 4, 2020
  • Manufacturing Science

4 Questions and 4 Answers About Innovation in Pharma Manufacturing

Jan 30, 2020
  • People

A Glimpse at FDA’s Micro Regulations

Jan 21, 2020
  • Quality & Regulatory
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EPA Hearing on EtO Draws Debate

Jan 21, 2020
  • Quality & Regulatory
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The Product Quality Leader Team Part I: Building the PQL Role

Jan 15, 2020
  • Quality & Regulatory

Panel Inspires Next Generation of Female Biotech Leaders

Jan 9, 2020
  • People
Members Only Content

5 Challenges of Closed System Transfer Devices

Jan 7, 2020
  • Manufacturing Science

PDA Enters 2020 on Strong Note

Jan 2, 2020
  • People

2020 Board of Directors

Jan 2, 2020
  • People

Joint PDA, IPEC TR Addresses Risk Assessments for Excipients

Dec 17, 2019
  • Quality & Regulatory
Members Only Content

PDA NE Chapter Enjoys a Day at the Lake

Dec 16, 2019
  • People
Members Only Content

ICH Q9: Quality Risk Management Revisions on Horizon

Dec 11, 2019
  • Quality & Regulatory
Members Only Content

Conference Proves “Virtually” Stimulating

Dec 7, 2019
  • People

FDA Panel Addresses EtO Sterilization

Dec 2, 2019
  • Aseptic Processing & Sterilization

Volunteers Needed for PDA Quality Culture Standard

Nov 18, 2019
  • Quality & Regulatory

Plunging into Six Sigma

Nov 11, 2019
  • Aseptic Processing & Sterilization
Members Only Content

Add Sherlock Holmes to Your Investigation Team

Nov 5, 2019
  • Aseptic Processing & Sterilization
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Get Your Data Integrity Basics Down for Success

Nov 4, 2019
  • Quality & Regulatory
Members Only Content

Robotics and Big Data Key to Lab of the Future

Nov 4, 2019
  • Manufacturing Science
Members Only Content

PDA Comments: PDA Input on USP 2020-2025 Revision Cycle

Nov 4, 2019
  • Quality & Regulatory
Members Only Content

How to Qualify Your Disinfectants

Nov 4, 2019
  • Aseptic Processing & Sterilization
Members Only Content

FDA Takes Close Look at Innovation

Nov 4, 2019
Members Only Content

PDA Comments: PDA Responds to EMA Combo Product Reg

Nov 4, 2019
  • Quality & Regulatory
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An Inside Look at the 2019 PDA Quality Week

Oct 27, 2019
  • Quality & Regulatory

Strategic Application of Advanced Analytics for CGT Development

Oct 20, 2019
  • Biopharmaceuticals & Biotechnology
Members Only Content

Tri-Spine Crab Now on Endangered List

Oct 13, 2019
  • Aseptic Processing & Sterilization
Members Only Content

Spotlight on Packaging Regulations and CCI

Oct 7, 2019
  • Quality & Regulatory

Can We Reprogram the Human Computer?

Sep 30, 2019
  • Biopharmaceuticals & Biotechnology
Members Only Content

Conference Puts Human Face on Cell and Gene Therapies

Sep 30, 2019
  • Biopharmaceuticals & Biotechnology

PDA Comments: Suggestions for FDA Voluntary Recalls Doc

Sep 30, 2019
  • Quality & Regulatory
Members Only Content

Publishing Intern Expands Horizons at PDA

Sep 30, 2019

Avoid Unmixed Process Solutions

Sep 30, 2019
  • Biopharmaceuticals & Biotechnology
Members Only Content

Incorporating QRM into Cell and Gene Therapy Processes

Sep 30, 2019
  • Quality & Regulatory

Life Science Panel Discusses Career Journeys

Sep 23, 2019
  • People

Are Your RMM Organisms Reflective of Your Process?

Sep 9, 2019
  • Aseptic Processing & Sterilization

PUPSIT and the Annex 1 Revision

Aug 29, 2019
  • Aseptic Processing & Sterilization

Ready for the Pharma of Tomorrow?

Aug 26, 2019
  • Manufacturing Science
Members Only Content

Volunteer Opportunities Abound!

Aug 26, 2019
  • People
Members Only Content

Supporting the Quality Risk Management Framework

Aug 26, 2019
  • Quality & Regulatory

Why is the EU Medical Device Regulation So Critical?

Aug 26, 2019
  • Quality & Regulatory

Human Error Causes OOS Investigation

Aug 26, 2019
  • Aseptic Processing & Sterilization
Members Only Content

PDA Comments: Concerns About USP <1235> Revision

Aug 26, 2019
  • Quality & Regulatory
Members Only Content

Lifecycle Approach Wipes Away Cleaning Validation Concerns

Aug 26, 2019
  • Aseptic Processing & Sterilization
Members Only Content

Student Learns Firsthand About Industry

Aug 12, 2019
  • People

Exciting Lineup of Speakers at the 2019 PDA/FDA JRC

Aug 8, 2019
  • Quality & Regulatory

Another Perspective on rFC

Aug 5, 2019
  • Aseptic Processing & Sterilization
Members Only Content

SE Chapter Helps Students Build Bridge to Future

Jul 29, 2019
  • People

ISO 22519: A Flawed and Counterproductive Standard

Jul 23, 2019
  • Aseptic Processing & Sterilization
Members Only Content

Ireland Chapter Addresses Annex 1 Revision

Jul 15, 2019
  • People

2019 PDA Summer Reading

Jul 9, 2019
  • People
Members Only Content

Follow the Audit Trail Breadcrumbs

Jul 9, 2019
  • Quality & Regulatory
Members Only Content

New Technology Meets Old Data Integrity Challenges

Jul 9, 2019
  • Quality & Regulatory
Members Only Content
U.S. FDA Continues Data Integrity Focus

U.S. FDA Continues Data Integrity Focus

Jul 9, 2019
  • Quality & Regulatory
Members Only Content

Networking Opportunities at 2019 PDA/FDA JRC

Jul 9, 2019
  • People

Foreign Particles in Bull’s Eye of Global Reg Agencies

Jul 9, 2019
  • Quality & Regulatory
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A Weeklong Look at Quality Risk Management

Jul 8, 2019
  • Quality & Regulatory
Members Only Content

Chapter Offers Coffee with PDA President

Jul 8, 2019
  • People
Members Only Content

Future of Packaging on Display at Stevanato Tour

Jul 8, 2019
  • People
Members Only Content

PDA Comments: Full Support for WHO WFI Guidance

Jul 8, 2019
  • Quality & Regulatory
Members Only Content

PDA/FDA JRC Conference Returns!

Jul 8, 2019
  • Quality & Regulatory

SoCal Student Chapter Keeps Busy

Jun 24, 2019
  • People

Excipients' Attributes Crucial for Parenteral Preparations

Jun 18, 2019
  • Supply Chain & Outsourcing
Members Only Content

More than Volcanoes or Solar System Models

Jun 10, 2019
  • People

PDA Comments: Ph. Eur. Tackles Endotoxin Alternative rFC

May 28, 2019
  • Quality & Regulatory

Aseptic Technology Advances to the Next Level

May 28, 2019
  • Aseptic Processing & Sterilization

The Role of Project Managers in Pharma

May 28, 2019
  • Quality & Regulatory

New ISO Standard Available for Water Systems

May 28, 2019
  • Aseptic Processing & Sterilization
Members Only Content

Gloveless Isolators Offer Speedy Throughput

May 28, 2019
  • Aseptic Processing & Sterilization
Members Only Content

U.S. FDA Rep Offers Overview on Visible Particulates

May 21, 2019
  • Quality & Regulatory
Members Only Content

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