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  • Manufacturing Science

Digital Transformation without the Transformation

  • David Hubmayr, Takeda Pharmaceuticals
  • Sep 28, 2022
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  • Manufacturing Science
  • Quality & Regulatory

GMP Challenges with Time Limitations in Pharma Manufacturing

  • Tony Cundell, PhD, Microbiological Consulting, LLC
  • Sep 8, 2022
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  • Quality & Regulatory
  • Aseptic Processing & Sterilization

Investigating Out-of-Specification Results for BET

  • Hayden Skalski, Sievers Instruments
  • Aug 17, 2022
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Robotics and AI Have Much to Offer Pharma

Apr 29, 2019
  • Manufacturing Science

PDA Comments: Drug Storage Regulations in Plain Language

Apr 29, 2019
  • Quality & Regulatory

Rock Out at the 4th PDA Europe Annual Meeting

Apr 29, 2019
  • People

The Future of Pharma is Coming to Europe

Apr 29, 2019
  • Manufacturing Science

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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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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Future Lies in Continuous Manufacturing Technology

Apr 1, 2019
  • Manufacturing Science
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Deep Dive into Biosimilars Continues

Apr 1, 2019
  • Quality & Regulatory

B. cepacia: What is it and Why is it a Concern?

Apr 1, 2019
  • Aseptic Processing & Sterilization
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PDA Comments: Viral Testing for Gene Therapies

Apr 1, 2019
  • Quality & Regulatory
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Rapid Micro Methods Carry Potential

Mar 26, 2019
  • Aseptic Processing & Sterilization

PDA Addresses LER in TR, Forthcoming Book

Mar 19, 2019
  • Aseptic Processing & Sterilization

NE Chapter Elects New Board, Plus Cold Storage

Mar 11, 2019
  • People
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Our Data Integrity Journey Has Only Just Begun

Mar 5, 2019
  • Quality & Regulatory

The Challenges of Visually Inspecting IV Bags

Feb 26, 2019
  • Manufacturing Science
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Implementation Proves Parametric Release Possible

Feb 25, 2019
  • Quality & Regulatory
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Viruses on the Surface

Feb 25, 2019
  • Biopharmaceuticals & Biotechnology
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Industry Eyes Future of Visual Inspection

Feb 25, 2019
  • Manufacturing Science
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Big Data is Here to Stay

Feb 25, 2019
  • Manufacturing Science

Student Chapter Gains Stem Cell Insights

Feb 25, 2019
  • People
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Vaccines, Biosimilars Share Commonalities

Feb 25, 2019
  • Quality & Regulatory
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Can the Power of Viruses be Harnessed for Good?

Feb 18, 2019
  • Biopharmaceuticals & Biotechnology

Change is in the Air for Packaging Components

Feb 12, 2019
  • Quality & Regulatory
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Biopharma Offers New Opportunities

Feb 5, 2019
  • Biopharmaceuticals & Biotechnology

A Roadmap to a Continuous Control Strategy

Jan 28, 2019
  • Manufacturing Science
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PUPSIT & the Proposed Annex 1 Revision

Jan 28, 2019
  • Quality & Regulatory
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Expand Your Network and Have Fun!

Jan 28, 2019
  • People

Thanks for the Warning Letter: Part II

Jan 28, 2019
  • Quality & Regulatory
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Response to "Standing Guard"

Jan 28, 2019
  • Aseptic Processing & Sterilization
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Global Regulators Partner for Greater Patient Access

Jan 28, 2019
  • Quality & Regulatory
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Take Cell and Gene Therapy Supply Challenges by the Horn

Jan 28, 2019
  • Biopharmaceuticals & Biotechnology
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Are You Up to Speed with Pharma’s Evolving Landscape?

Jan 28, 2019
  • Manufacturing Science

Growth Promotion Testing For EM

Jan 22, 2019
  • Aseptic Processing & Sterilization

Data Integrity Validated as Key Issue

Jan 15, 2019
  • People

Alternative to LAL Gains Ground

Jan 8, 2019
  • Aseptic Processing & Sterilization
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Regulatory Concerns Drive New Developments in Glass Packaging

Jan 2, 2019
  • Quality & Regulatory
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An Overview of Container Closure Integrity

Jan 2, 2019
  • Aseptic Processing & Sterilization
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Current Perspectives on the Monocyte Activation Test

Jan 2, 2019
  • Aseptic Processing & Sterilization
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Innovative Tech Drives Drug Shortage Solutions

Jan 2, 2019
  • Quality & Regulatory
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Are You (and Pharma) Ready for the Future?

Jan 2, 2019
  • Manufacturing Science

India Chapter Gets Hands-On with CCI Tech

Dec 17, 2018
  • People
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EMA's Amsterdam Move Reflects Larger Trend

Dec 11, 2018
  • Quality & Regulatory

Holistic Verification Requires a New Mindset

Dec 3, 2018
  • Quality & Regulatory
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Industry and Regulators Convene to Address Vaccines Challenges

Nov 26, 2018
  • Manufacturing Science

Industry 4.0 and Drug Manufacturing

Nov 12, 2018
  • Manufacturing Science
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FDA's ORA Realignment, MRA, NIPP, Concept of Operations: How it All Fits Together

Nov 6, 2018
  • Quality & Regulatory
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Hidden Contamination in Starting Materials

Nov 6, 2018
  • Aseptic Processing & Sterilization
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Process, Interrupted

Nov 6, 2018
  • Aseptic Processing & Sterilization
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Thanks for the Warning Letter: Part I

Nov 6, 2018
  • Quality & Regulatory
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Reconstitution and Storage Times for Lyo Products

Nov 5, 2018
  • Aseptic Processing & Sterilization
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Glass Breakage in Pharmaceutical Packaging

Nov 5, 2018
  • Manufacturing Science
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Risk Management Shines Light on ICH Q12 Use for Biologics

Nov 5, 2018
  • Quality & Regulatory
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PDA Forms New Chapter in Pacific Northwest

Nov 5, 2018
  • People

Modular Manufacturing Begins to Take Hold

Oct 31, 2018
  • Manufacturing Science
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West Coast Chapter Hosts Women in Biopharma Panel

Oct 22, 2018
  • People
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Future Challenges in Visual Inspection Processes

Oct 16, 2018
  • Quality & Regulatory
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Big Data, Pharma 4.0 and Legacy Products

Oct 2, 2018
  • Manufacturing Science
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Big Data: The Panacea for Pharma’s Ills?

Oct 1, 2018
  • Manufacturing Science
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Build Your CCI Knowledge Base Through Data, Tech

Oct 1, 2018
  • Biopharmaceuticals & Biotechnology
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Meet the PDA Letter’s First Intern

Oct 1, 2018
  • People
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Hot Read: GMP in Practice

Oct 1, 2018
  • Quality & Regulatory

Exciting New Changes are Coming to Pharma

Oct 1, 2018
  • Manufacturing Science
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Pharmacy Student Sees Future of Pharma in Berlin

Oct 1, 2018
  • People
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Risk-Benefit Analysis More of NCA Scope

Oct 1, 2018
  • Quality & Regulatory
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New Perspectives on Freeze-Drying

Oct 1, 2018
  • Biopharmaceuticals & Biotechnology

Southeast Chapter Meeting Pairs Wine, Decon Tech

Oct 1, 2018
  • People
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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
Members Only Content

Blockchain: Will it Transform the Pharmaceutical Supply Chain?

Jul 9, 2018
  • Supply Chain & Outsourcing
Members Only Content

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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