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  • Aseptic Processing & Sterilization
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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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Are You Ready for the eCTD Mandate?

Jul 9, 2018
  • Quality & Regulatory
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A Not-So-Sweet Smell: Part II

Jul 9, 2018
  • Supply Chain & Outsourcing
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Quality/Compliance Management for Virtual Companies

Jul 9, 2018
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Five Critical Endotoxin Testing Concerns

Jul 9, 2018
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Opportunities to Build and Grow Your Network

Jul 9, 2018
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Visual Inspection Remains Critical

Jul 9, 2018
  • Quality & Regulatory
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How to Best Tackle Biosimilar Challenges

Jul 9, 2018
  • Biopharmaceuticals & Biotechnology

3 Questions for Biogen’s Amy Wilson

Jun 25, 2018
  • Manufacturing Science
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Pharma Must Work “Smarter” in New Era

Jun 19, 2018
  • Manufacturing Science
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Chapter Grows Professional Opportunities Across Industry

Jun 5, 2018
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Prospects for Post-Approval Change Management

May 29, 2018
  • Quality & Regulatory
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Eyeing the Future of Biomanufacturing

May 29, 2018
  • People
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A Not-So-Sweet Smell: Part I

May 29, 2018
  • Supply Chain & Outsourcing
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Can ICH Q12 Unlock Manufacturing Innovation?

May 29, 2018
  • Quality & Regulatory
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Growing Acceptance of Real-Time Monitoring

May 29, 2018
  • Aseptic Processing & Sterilization

Seeing the Light

May 29, 2018
  • Quality & Regulatory
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Getting Biosimilars Right the First Time

May 29, 2018
  • Biopharmaceuticals & Biotechnology

Knowledge Grows for mAb Development

May 29, 2018
  • Biopharmaceuticals & Biotechnology

A Wealth of New Tech Possibilities

May 16, 2018
  • Manufacturing Science
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A Tale of Two Vials

May 7, 2018
  • Manufacturing Science
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3-D Printing and Biopharmaceutical Manufacturing

Apr 30, 2018
  • Manufacturing Science
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Strategies for Reducing Data Integrity Challenges

Apr 30, 2018
  • Quality & Regulatory
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PDA Responds to Annex 1 Revision

Apr 30, 2018
  • Quality & Regulatory

Container Closure Integrity Requires Adaptation

Apr 30, 2018
  • Quality & Regulatory
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RMAT Program Raises a Few Questions

Apr 30, 2018
  • Biopharmaceuticals & Biotechnology
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Make New Buddies in Berlin

Apr 30, 2018
  • People

Running the Numbers for Analytical Similarity

Apr 30, 2018
  • Quality & Regulatory
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Amgen Team Brings Expertise to Taiwan Chapter

Apr 30, 2018
  • People
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Glass Versus Cyclic Olefin Polymers

Apr 25, 2018
  • Manufacturing Science
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New Drugs Need Agile Biomanufacturing

Apr 17, 2018
  • Manufacturing Science
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Speaking the Language of GMP

Apr 3, 2018
  • Biopharmaceuticals & Biotechnology
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Packaging Critical to Success of Drug Products

Apr 2, 2018
  • Quality & Regulatory
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Know Your Numbers for Analytical Similarity

Apr 2, 2018
  • Biopharmaceuticals & Biotechnology
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PDA Celebrates Ten Years of ATMP Conferences

Apr 2, 2018
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ATMPs: What a Difference a Year Can Make

Apr 2, 2018
  • Quality & Regulatory

Moving the Patient to the Forefront

Apr 2, 2018
  • Manufacturing Science
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Cell and Gene Therapies Present Challenges, Promise

Apr 2, 2018
  • Biopharmaceuticals & Biotechnology
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Volunteering Opens Doors for Student Chapter

Apr 2, 2018
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Sterilizing Grade Filters and PUPSIT

Mar 28, 2018
  • Aseptic Processing & Sterilization
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Novel Manufacturing Tech Drives Novel Product Development

Mar 20, 2018
  • Manufacturing Science
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Glass Along the Value Chain

Mar 13, 2018
  • Manufacturing Science
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Awareness Critical for Container Closure Components

Mar 6, 2018
  • Quality & Regulatory

Honoring PDA’s Female Volunteer Leaders

Feb 26, 2018
  • People

Smoke Signals

Feb 26, 2018
  • Aseptic Processing & Sterilization
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New Approach Suggests Continuous Lyophilization is Possible

Feb 26, 2018
  • Biopharmaceuticals & Biotechnology
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PDA Staff Try a Hand at Aseptic Processing

Feb 26, 2018
  • People
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Seeing the Hidden

Feb 26, 2018
  • Aseptic Processing & Sterilization
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Korea Chapter Inaugurates New KPDA Hall

Feb 26, 2018
  • People
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H20 Requirements for Superheated Sterilization

Feb 26, 2018
  • Aseptic Processing & Sterilization
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Changes to USP Council of Experts

Feb 26, 2018
  • Quality & Regulatory
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New Tech Disrupts Traditional Aseptic Processing

Feb 20, 2018
  • Aseptic Processing & Sterilization

Adapt Your Nest-and-Tub System as the Industry Evolves

Feb 13, 2018
  • Manufacturing Science
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New Trends Require Investment from Vaccine Makers

Feb 6, 2018
  • Biopharmaceuticals & Biotechnology

High Regulatory Expectations for Biosimilars

Jan 30, 2018
  • Quality & Regulatory
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More Opportunities to Grow Your Network

Jan 29, 2018
  • People

Teamwork Crucial to SUS Sterilization Validation

Jan 29, 2018
  • Aseptic Processing & Sterilization

Formalizing a Risk Assessment for Excipients

Jan 29, 2018
  • Quality & Regulatory

PDA Prefilled Syringes Exhibition Draws Crowd

Jan 29, 2018
  • People
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Extractables Testing of Aluminosilicate and Borosilicate Glass Containers

Jan 29, 2018
  • Manufacturing Science
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Student Chapter Shows Enthusiasm for Industry

Jan 29, 2018
  • People
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4 Capabilities to Operationalizing Resilience

Jan 29, 2018
  • Manufacturing Science
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Achieve True Manufacturing Reliability

Jan 23, 2018
  • Manufacturing Science

Chapter Learns About Future of Facility Design

Jan 16, 2018
  • People
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Quality and Innovation are Not Incompatible

Jan 9, 2018
  • Quality & Regulatory
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Quality: One Question, Many Answers

Jan 9, 2018
  • Quality & Regulatory
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Collaboration Through Mutual Reliance Brings FDA and EMA to the Table

Jan 2, 2018
  • Quality & Regulatory
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Monitor Viable Air with Single-Use, Real-Time Tech

Jan 2, 2018
  • Aseptic Processing & Sterilization

Disruptive Change is on the Horizon

Jan 2, 2018
  • Manufacturing Science

Flexibility Needed for PAC

Jan 2, 2018
  • Quality & Regulatory

Regulators Tackle Tough Micro Questions on Panel

Jan 2, 2018
  • Quality & Regulatory
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New PDA Task Force Targets Big Data

Dec 13, 2017
  • Manufacturing Science

Brazil Chapter Offers Hands-On Aseptic Training

Dec 5, 2017
  • People
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Cracking the Challenges of Glass Packaging

Nov 28, 2017
  • Quality & Regulatory

Millennials: How Manufacturers are Training the Next Generation

Nov 6, 2017
  • People
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Record Scholarships Awarded at NE Chapter Dinner

Nov 6, 2017
  • People
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CFDA Encouraged to Review PDA Docs

Nov 6, 2017
  • Quality & Regulatory
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PDA Staff Gown Up for Site Visit at Pilot Plant

Nov 6, 2017
  • People
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PDA on the Move

Nov 6, 2017
  • People
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Worst-Case Analysis of Cell Growth in SUS

Nov 6, 2017
  • Manufacturing Science
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Networking Lights Up PDA/FDA JRC Exhibit Hall

Nov 6, 2017
  • People
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Isolator Surfaces and Contamination Risks to Personnel

Nov 6, 2017
  • Aseptic Processing & Sterilization
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AIDC is a Sign of Things to Come: Part II

Oct 31, 2017
  • Supply Chain & Outsourcing
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AIDC is a Sign of Things to Come: Part I

Oct 31, 2017
  • Supply Chain & Outsourcing
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A Risk Assessment is an Opportunity Assessment

Oct 18, 2017
  • Quality & Regulatory

PDA and IFPMA Foster Discussion on PAC

Oct 10, 2017
  • Quality & Regulatory

Prefilled Syringe Manufacturing Moves Away from Hands-On Approach

Oct 3, 2017
  • Manufacturing Science
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Two Views on Packaging from Prefilled Exhibitors

Oct 3, 2017
  • Manufacturing Science
  • Members Only
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Five Keys to Manufacturing Success

Oct 3, 2017
  • Manufacturing Science
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One Company’s Approach to Rapid Micro Methods

Oct 3, 2017
  • Aseptic Processing & Sterilization
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Ireland Chapter Provides Once in a Lifetime Trip

Oct 3, 2017
  • People
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New Realities for Prefilled Syringes

Sep 27, 2017
  • Quality & Regulatory

Industry Awaits Annex 1 Revision

Sep 19, 2017
  • Quality & Regulatory
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The QC Lab of the Future

Sep 13, 2017
  • Manufacturing Science
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Novel Drug Products Drive New Views on Suitability

Aug 29, 2017
  • Quality & Regulatory

Visual Inspection Faces Changing Environment

Aug 29, 2017
  • Manufacturing Science

One Simple Way to Manage Aseptic Risk Assessments

Aug 29, 2017
  • Aseptic Processing & Sterilization
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Company Sees Success With Automated Endotoxin Testing

Aug 29, 2017
  • Aseptic Processing & Sterilization
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Four Steps to Ensuring Data Integrity for BET

Aug 29, 2017
  • Quality & Regulatory
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Why the Surface is Critical to Disinfection Testing

Aug 29, 2017
  • Aseptic Processing & Sterilization
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PQS: An Effective Lever for Managing PACs

Aug 22, 2017
  • Quality & Regulatory

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