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Parenteral Drug Association
Connecting People, Science and Regulation
®
Parenteral Drug Association
Connecting People, Science and Regulation
®
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Manufacturing Science
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Qualification of Manual Visual Inspection Still Critical
Alexis Flaquiere and Jean Malthête, GSK Vaccines
Mar 19, 2020
Biopharmaceuticals & Biotechnology
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Inaugural BioManufacturing Conference Tackles Five Key Issues: Part II
Michael De Felippis, PhD, Eli Lilly, and Cristiana Campa, PhD, GSK
Mar 3, 2020
Biopharmaceuticals & Biotechnology
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Inaugural BioManufacturing Conference Tackles Five Key Issues: Part I
Michael DeFelippis, PhD, Eli Lilly, and Cristiana Campa, PhD, GSK
Feb 18, 2020
Article Categories
Guest Editorial: We Should Expect Drug Shortages to Get Worse
Mar 27, 2020
Supply Chain & Outsourcing
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Real-World Applications of Rapid Micro Methods
Mar 26, 2020
Aseptic Processing & Sterilization
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Cryogenic Storage Challenges for Container-Closure Systems
Mar 25, 2020
Biopharmaceuticals & Biotechnology
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Sterility Test Failure Investigations
Mar 24, 2020
Aseptic Processing & Sterilization
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9 Tips to Make Working Remotely Work for You and Your Employer
Mar 24, 2020
People
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Qualification of Manual Visual Inspection Still Critical
Mar 19, 2020
Manufacturing Science
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New Look for the PDA Letter! Plus, All New Content Unlocked
Mar 18, 2020
People
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The Product Quality Leader Team Part II: Getting Ahead
Mar 17, 2020
Biopharmaceuticals & Biotechnology
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Moving Beyond “Grande-Sized” Manufacturing for Gene Therapies
Mar 12, 2020
Biopharmaceuticals & Biotechnology
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PDA Responds to the Novel Coronavirus Situation
Mar 11, 2020
People
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Tools to Address Human Error Reduction
Mar 11, 2020
People
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40 Years of Visual Inspection: Where Do We Go from Here?
Mar 5, 2020
Manufacturing Science
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Inaugural BioManufacturing Conference Tackles Five Key Issues: Part II
Mar 3, 2020
Biopharmaceuticals & Biotechnology
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Data Integrity: From the Basics to Big Data
Feb 27, 2020
Quality & Regulatory
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Innovations in Aseptic Processing
Feb 25, 2020
Aseptic Processing & Sterilization
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Annex 1 to VPHP: The ABCs of Aseptic Processing
Feb 20, 2020
People
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Inaugural BioManufacturing Conference Tackles Five Key Issues: Part I
Feb 18, 2020
Biopharmaceuticals & Biotechnology
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Board of Directors Nominations Needed
Feb 13, 2020
People
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New Decade, New Focus for PDA Letter
Feb 13, 2020
People
Aseptic Processing & Sterilization
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Female Biotech Leaders Discuss Their Career Journeys, Offer Advice
Feb 11, 2020
People
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5.0 Ways Quality 4.0 Will Improve Manufacturing
Feb 6, 2020
Quality & Regulatory
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Could A.I. Optimize Visual Inspection?
Feb 4, 2020
Manufacturing Science
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4 Questions and 4 Answers About Innovation in Pharma Manufacturing
Jan 30, 2020
People
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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
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Panel Inspires Next Generation of Female Biotech Leaders
Jan 9, 2020
People
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5 Challenges of Closed System Transfer Devices
Jan 7, 2020
Manufacturing Science
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PDA Enters 2020 on Strong Note
Jan 2, 2020
People
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2020 Board of Directors
Jan 2, 2020
People
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Joint PDA, IPEC TR Addresses Risk Assessments for Excipients
Dec 17, 2019
Quality & Regulatory
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PDA NE Chapter Enjoys a Day at the Lake
Dec 16, 2019
People
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ICH Q9: Quality Risk Management Revisions on Horizon
Dec 11, 2019
Quality & Regulatory
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Conference Proves “Virtually” Stimulating
Dec 7, 2019
People
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FDA Panel Addresses EtO Sterilization
Dec 2, 2019
Aseptic Processing & Sterilization
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Volunteers Needed for PDA Quality Culture Standard
Nov 18, 2019
Quality & Regulatory
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Plunging into Six Sigma
Nov 11, 2019
Aseptic Processing & Sterilization
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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
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Robotics and Big Data Key to Lab of the Future
Nov 4, 2019
Manufacturing Science
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PDA Comments: PDA Input on USP 2020-2025 Revision Cycle
Nov 4, 2019
Quality & Regulatory
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How to Qualify Your Disinfectants
Nov 4, 2019
Aseptic Processing & Sterilization
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FDA Takes Close Look at Innovation
Nov 4, 2019
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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
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Strategic Application of Advanced Analytics for CGT Development
Oct 20, 2019
Biopharmaceuticals & Biotechnology
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Tri-Spine Crab Now on Endangered List
Oct 13, 2019
Aseptic Processing & Sterilization
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Spotlight on Packaging Regulations and CCI
Oct 7, 2019
Quality & Regulatory
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Can We Reprogram the Human Computer?
Sep 30, 2019
Biopharmaceuticals & Biotechnology
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Conference Puts Human Face on Cell and Gene Therapies
Sep 30, 2019
Biopharmaceuticals & Biotechnology
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PDA Comments: Suggestions for FDA Voluntary Recalls Doc
Sep 30, 2019
Quality & Regulatory
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Publishing Intern Expands Horizons at PDA
Sep 30, 2019
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Avoid Unmixed Process Solutions
Sep 30, 2019
Biopharmaceuticals & Biotechnology
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Incorporating QRM into Cell and Gene Therapy Processes
Sep 30, 2019
Quality & Regulatory
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Life Science Panel Discusses Career Journeys
Sep 23, 2019
People
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Are Your RMM Organisms Reflective of Your Process?
Sep 9, 2019
Aseptic Processing & Sterilization
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PUPSIT and the Annex 1 Revision
Aug 29, 2019
Aseptic Processing & Sterilization
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Ready for the Pharma of Tomorrow?
Aug 26, 2019
Manufacturing Science
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Volunteer Opportunities Abound!
Aug 26, 2019
People
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Supporting the Quality Risk Management Framework
Aug 26, 2019
Quality & Regulatory
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Why is the EU Medical Device Regulation So Critical?
Aug 26, 2019
Quality & Regulatory
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Human Error Causes OOS Investigation
Aug 26, 2019
Aseptic Processing & Sterilization
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PDA Comments: Concerns About USP <1235> Revision
Aug 26, 2019
Quality & Regulatory
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Lifecycle Approach Wipes Away Cleaning Validation Concerns
Aug 26, 2019
Aseptic Processing & Sterilization
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Student Learns Firsthand About Industry
Aug 12, 2019
People
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Exciting Lineup of Speakers at the 2019 PDA/FDA JRC
Aug 8, 2019
Quality & Regulatory
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Another Perspective on rFC
Aug 5, 2019
Aseptic Processing & Sterilization
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SE Chapter Helps Students Build Bridge to Future
Jul 29, 2019
People
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ISO 22519: A Flawed and Counterproductive Standard
Jul 23, 2019
Aseptic Processing & Sterilization
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Ireland Chapter Addresses Annex 1 Revision
Jul 15, 2019
People
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2019 PDA Summer Reading
Jul 9, 2019
People
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Follow the Audit Trail Breadcrumbs
Jul 9, 2019
Quality & Regulatory
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New Technology Meets Old Data Integrity Challenges
Jul 9, 2019
Quality & Regulatory
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U.S. FDA Continues Data Integrity Focus
Jul 9, 2019
Quality & Regulatory
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Networking Opportunities at 2019 PDA/FDA JRC
Jul 9, 2019
People
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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
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Chapter Offers Coffee with PDA President
Jul 8, 2019
People
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Future of Packaging on Display at Stevanato Tour
Jul 8, 2019
People
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PDA Comments: Full Support for WHO WFI Guidance
Jul 8, 2019
Quality & Regulatory
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PDA/FDA JRC Conference Returns!
Jul 8, 2019
Quality & Regulatory
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SoCal Student Chapter Keeps Busy
Jun 24, 2019
People
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Excipients' Attributes Crucial for Parenteral Preparations
Jun 18, 2019
Supply Chain & Outsourcing
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More than Volcanoes or Solar System Models
Jun 10, 2019
People
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PDA Comments: Ph. Eur. Tackles Endotoxin Alternative rFC
May 28, 2019
Quality & Regulatory
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Aseptic Technology Advances to the Next Level
May 28, 2019
Aseptic Processing & Sterilization
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The Role of Project Managers in Pharma
May 28, 2019
Quality & Regulatory
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New ISO Standard Available for Water Systems
May 28, 2019
Aseptic Processing & Sterilization
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Members Only Content
Gloveless Isolators Offer Speedy Throughput
May 28, 2019
Aseptic Processing & Sterilization
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U.S. FDA Rep Offers Overview on Visible Particulates
May 21, 2019
Quality & Regulatory
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Cell and Gene Manufacturing Grows in Singapore
May 14, 2019
People
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Highly Potent APIs: Balancing Patient and Operator Safety
Apr 29, 2019
Aseptic Processing & Sterilization
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Robotics and AI Have Much to Offer Pharma
Apr 29, 2019
Manufacturing Science
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PDA Comments: Drug Storage Regulations in Plain Language
Apr 29, 2019
Quality & Regulatory
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Rock Out at the 4th PDA Europe Annual Meeting
Apr 29, 2019
People
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The Future of Pharma is Coming to Europe
Apr 29, 2019
Manufacturing Science
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Building an Efficient QRM Strategy
Apr 29, 2019
People
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A Patient’s Life Depends on Product Quality
Apr 22, 2019
Aseptic Processing & Sterilization
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Members Only Content
Air Bubbles versus Transparent Particles
Apr 9, 2019
Manufacturing Science
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The Pharmacopeia in the 21st Century
Apr 1, 2019
Quality & Regulatory
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