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  • Aseptic Processing & Sterilization

Annex 1 and the New Revision — Setting New Expectations

  • Glenn Wright, PDA, Inc.
  • Oct 20, 2021
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  • Quality & Regulatory

How to Measure Quality Management Maturity

  • Denyse Baker, Jeff Broadfoot, Steve Mendivil, Adam Caruso, and Sandra Lueken
  • Sep 23, 2021
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  • Manufacturing Science

COVID-19 Related Shortages of Manufacturing Components — There is a Way Through!

  • Denyse Baker, AstraZeneca
  • Aug 25, 2021
  • Article Categories

Standing Guard

Sep 26, 2018
  • Aseptic Processing & Sterilization

Endotoxin Testing Using Recombinant Reagents

Sep 18, 2018
  • Aseptic Processing & Sterilization

A Deep Dive into Pharmacopeial Harmonization

Sep 11, 2018
  • Quality & Regulatory
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Deep Learning in the Information Swamp

Sep 11, 2018
  • Manufacturing Science

Does QRM + RMM = Better EM?

Sep 4, 2018
  • Aseptic Processing & Sterilization

Build Connections at Two PDA Events

Aug 27, 2018
  • People

New Trends, New Challenges for BET

Aug 27, 2018
  • Aseptic Processing & Sterilization
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Going Beyond Patient Preference

Aug 27, 2018
  • Manufacturing Science

What Annex 1 Means for Sterilization and Moist Steam

Aug 27, 2018
  • Aseptic Processing & Sterilization
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Drug Delivery Combination Products Go “Viral”

Aug 27, 2018
  • Quality & Regulatory

Draft Annex 1 Separates Cleaning and Disinfection

Aug 27, 2018
  • Aseptic Processing & Sterilization
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Biologics Packaging Presents Risks

Aug 27, 2018
  • Manufacturing Science
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Data Integrity in the Age of Metadata and Big Data

Aug 27, 2018
  • Quality & Regulatory
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Revised USP Micro Chapters Address Changing Technologies

Aug 27, 2018
  • Aseptic Processing & Sterilization
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A Wealth of New Micro Regulations

Aug 27, 2018
  • Quality & Regulatory
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Strategies to Address E/L Container Closure Challenges

Aug 23, 2018
  • Quality & Regulatory

Industry Converges on Pharmacopeial Convergence

Aug 21, 2018
  • Quality & Regulatory
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India Chapter Goes into the Cold

Aug 14, 2018
  • People
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Visual Inspection Workshop Addresses Annex 1, New Tech

Aug 7, 2018
  • Manufacturing Science
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Russian GMP Inspections Present Challenges, Opportunities: Part II

Jul 31, 2018
  • Quality & Regulatory
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Russian GMP Inspections Present Challenges, Opportunities: Part I

Jul 31, 2018
  • Quality & Regulatory
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Not So Different After All

Jul 24, 2018
  • People

Reclaiming Efficiency Amid Serialization Nightmares

Jul 24, 2018
  • Supply Chain & Outsourcing
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Evaluating Cell Viability After Cryopreservation

Jul 17, 2018
  • Biopharmaceuticals & Biotechnology
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PDA Participates in Nipro Experience Days

Jul 17, 2018
  • People
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New Serialization Regs Impact Global Pharma

Jul 9, 2018
  • Supply Chain & Outsourcing
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2018 PDA Summer Reading

Jul 9, 2018
  • People
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A Risk-Based Approach to Supplier Management

Jul 9, 2018
  • Supply Chain & Outsourcing
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Viscous Product No Match for New CCI Tech

Jul 9, 2018
  • Aseptic Processing & Sterilization
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Blockchain: Will it Transform the Pharmaceutical Supply Chain?

Jul 9, 2018
  • Supply Chain & Outsourcing
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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
  • Quality & Regulatory
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Five Critical Endotoxin Testing Concerns

Jul 9, 2018
  • Aseptic Processing & Sterilization
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Opportunities to Build and Grow Your Network

Jul 9, 2018
  • People

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
  • People
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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
  • Members Only
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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
Members Only Content

PDA Celebrates Ten Years of ATMP Conferences

Apr 2, 2018
  • People

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
  • People
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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
Members Only Content

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
Members Only Content

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
Members Only Content

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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