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  • Aseptic Processing & Sterilization

The Moldy Nightmare: Questions and Answers, Part 2

  • Ziva Abraham, Microlite, Inc.
  • Jan 20, 2021
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  • Aseptic Processing & Sterilization

The Moldy Nightmare: Questions and Answers, Part 1

  • Ziva Abraham, Microlite, Inc.
  • Jan 6, 2021
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  • Supply Chain & Outsourcing

Worried about the availability of primary packaging for the COVID Vaccine? It’s a logistics challenge, not a supply challenge

  • Martin Van Trieste, President & CEO, Civica Rx
  • Dec 2, 2020
  • Article Categories
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

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

PDA Members Save Substantially