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  • Quality & Regulatory

Best Practice Guide for Using KPI’s/Metrics

  • Bernhard Hinsch, Hinsch Consulting
  • Jul 22, 2020
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  • Biopharmaceuticals & Biotechnology

CBER Continues to Analyze Next-Gen Sequencing

  • Rebecca Stauffer, PDA
  • Jul 9, 2020
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  • Supply Chain & Outsourcing

Pharma Firm Explores RFID for Prefilled Syringes

  • Gabriele Peron, Stevanato Group
  • Jun 23, 2020
  • Article Categories
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

PDA Honor Awards: Honorary Membership

Jul 7, 2020
  • People
Italy Chapter Looks Ahead

Italy Chapter Looks Ahead

Jul 7, 2020
  • People
Standard Offers Guide for Supplier Management

Standard Offers Guide for Supplier Management

Jul 2, 2020
  • Supply Chain & Outsourcing
Industry Must Move Away from Dye Ingress Test

Industry Must Move Away from Dye Ingress Test

Jun 30, 2020
  • Manufacturing Science

PDA Honor Awards: President’s Award

Jun 29, 2020
  • People

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

Jun 25, 2020
  • People
rFC Offers Many Advantages for Industry

rFC Offers Many Advantages for Industry

Jun 25, 2020
  • Aseptic Processing & Sterilization
Pharma Firm Explores RFID for Prefilled Syringes

Pharma Firm Explores RFID for Prefilled Syringes

Jun 23, 2020
  • Supply Chain & Outsourcing

PDA Honor Awards: Gordon Personeus and Frederick Carleton Awards

Jun 22, 2020
  • People

PDA Honor Awards: PDA Publications

Jun 18, 2020
  • People
Risk-Based Approaches to Data Integrity in Manufacturing

Risk-Based Approaches to Data Integrity in Manufacturing

Jun 17, 2020
  • Regulatory
New PDA Task Force Offers Resources for Industry

New PDA Task Force Offers Resources for Industry

Jun 16, 2020
  • People
The Use of Scientific Data to Assess and Control Risks Associated with Sterilizing Filtration

The Use of Scientific Data to Assess and Control Risks Associated with Sterilizing Filtration

Jun 15, 2020
  • Aseptic Processing & Sterilization

PDA Honor Awards: EU Service Award and Agalloco Award

Jun 11, 2020
  • People
St. Gallen Seeks OpEx Info from Industry

St. Gallen Seeks OpEx Info from Industry

Jun 11, 2020
  • Quality & Regulatory
Regulator Develops Remote Inspection Process Due to Pandemic

Regulator Develops Remote Inspection Process Due to Pandemic

Jun 9, 2020
  • Quality & Regulatory

PDA Honor Awards: Distinguished Service Awards

Jun 9, 2020
  • People

PDA Honor Awards: Service Appreciation Awards Part II

Jun 9, 2020
  • People
States Temporarily Relax EtO Restrictions

States Temporarily Relax EtO Restrictions

Jun 4, 2020
  • Aseptic Processing & Sterilization

PDA and PDA Letter Plow Ahead

Jun 3, 2020
  • People
10 Practical Tips for Crisis Management in Pharma Manufacturing

10 Practical Tips for Crisis Management in Pharma Manufacturing

Jun 3, 2020
  • Manufacturing Science

PDA Honor Awards: Service Appreciation Awards Part I

May 29, 2020
  • People
A Virtual Look at Risk Management for Prefilled Syringes

A Virtual Look at Risk Management for Prefilled Syringes

May 28, 2020
  • People
Closed System Transfer Devices Prove Hot PDA Topic

Closed System Transfer Devices Prove Hot PDA Topic

May 27, 2020
  • Manufacturing Science
CEO Showcases Future of CGT Therapies for PDA Chapter

CEO Showcases Future of CGT Therapies for PDA Chapter

May 21, 2020
  • People
3 Approaches to Viral Safety

3 Approaches to Viral Safety

May 20, 2020
  • Biopharmaceuticals & Biotechnology

Container Closure Integrity Testing with Lauren Lavec

May 14, 2020
4 Ways to Manage Your Supply Chain and Mitigate Drug Shortages

4 Ways to Manage Your Supply Chain and Mitigate Drug Shortages

May 12, 2020
  • Supply Chain & Outsourcing
Dinner Meeting Addresses Virtual Companies, Preapproval Inspections

Dinner Meeting Addresses Virtual Companies, Preapproval Inspections

May 7, 2020
  • People
Visual Inspection Practices of Cleaned Equipment: Part II

Visual Inspection Practices of Cleaned Equipment: Part II

May 5, 2020
  • Aseptic Processing & Sterilization
Guest Editorial: A Litmus Test for a Culture of Quality

Guest Editorial: A Litmus Test for a Culture of Quality

Apr 30, 2020
  • Quality & Regulatory
Chapter Covers New Developments in Visual Inspection

Chapter Covers New Developments in Visual Inspection

Apr 29, 2020
  • People
PDA Comments Address Risk Management Approach to Gene Therapy CMC

PDA Comments Address Risk Management Approach to Gene Therapy CMC

Apr 28, 2020
  • Quality & Regulatory
New Vial Technology Shows Promise for Manufacturing Productivity

New Vial Technology Shows Promise for Manufacturing Productivity

Apr 23, 2020
  • Manufacturing Science

PDA Board of Directors Changes

Apr 22, 2020
  • People
Guest Editorial: Consulting Firms Can Fill in Missing Pieces

Guest Editorial: Consulting Firms Can Fill in Missing Pieces

Apr 21, 2020
  • People
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
Members Only Content

EPA Hearing on EtO Draws Debate

Jan 21, 2020
  • Quality & Regulatory
Members Only Content

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
Members Only Content

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
Members Only Content

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

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