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  • Quality & Regulatory

You Had Micro Questions, FDA Had Big Answers

  • Marilyn L. Foster, PDA
  • May 4, 2022
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  • Quality & Regulatory

Merck Streamlines Quality Management with the Cloud

  • Mike Jovanis, Vice President of Vault Quality at Veeva Systems
  • Apr 20, 2022
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  • Manufacturing Science

Initial Evaluation Roadmap for Modern Microbial Methods

  • Claire Fritz Briglia, Vedere Solutions LLC, et al.
  • Apr 6, 2022
  • Article Categories

Current Perspectives on the Monocyte Activation Test

Jan 2, 2019
  • Aseptic Processing & Sterilization
Members Only Content

Innovative Tech Drives Drug Shortage Solutions

Jan 2, 2019
  • Quality & Regulatory
Members Only Content

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
Members Only Content

EMA's Amsterdam Move Reflects Larger Trend

Dec 11, 2018
  • Quality & Regulatory

Holistic Verification Requires a New Mindset

Dec 3, 2018
  • Quality & Regulatory
Members Only Content

Industry and Regulators Convene to Address Vaccines Challenges

Nov 26, 2018
  • Manufacturing Science

Industry 4.0 and Drug Manufacturing

Nov 12, 2018
  • Manufacturing Science
Members Only Content

FDA's ORA Realignment, MRA, NIPP, Concept of Operations: How it All Fits Together

Nov 6, 2018
  • Quality & Regulatory
Members Only Content

Hidden Contamination in Starting Materials

Nov 6, 2018
  • Aseptic Processing & Sterilization
Members Only Content

Process, Interrupted

Nov 6, 2018
  • Aseptic Processing & Sterilization
Members Only Content

Thanks for the Warning Letter: Part I

Nov 6, 2018
  • Quality & Regulatory
Members Only Content

Reconstitution and Storage Times for Lyo Products

Nov 5, 2018
  • Aseptic Processing & Sterilization
Members Only Content

Glass Breakage in Pharmaceutical Packaging

Nov 5, 2018
  • Manufacturing Science
Members Only Content

Risk Management Shines Light on ICH Q12 Use for Biologics

Nov 5, 2018
  • Quality & Regulatory
Members Only Content

PDA Forms New Chapter in Pacific Northwest

Nov 5, 2018
  • People

Modular Manufacturing Begins to Take Hold

Oct 31, 2018
  • Manufacturing Science
Members Only Content

West Coast Chapter Hosts Women in Biopharma Panel

Oct 22, 2018
  • People
Members Only Content

Future Challenges in Visual Inspection Processes

Oct 16, 2018
  • Quality & Regulatory
Members Only Content

Big Data, Pharma 4.0 and Legacy Products

Oct 2, 2018
  • Manufacturing Science
Members Only Content

Big Data: The Panacea for Pharma’s Ills?

Oct 1, 2018
  • Manufacturing Science
Members Only Content

Build Your CCI Knowledge Base Through Data, Tech

Oct 1, 2018
  • Biopharmaceuticals & Biotechnology
Members Only Content

Meet the PDA Letter’s First Intern

Oct 1, 2018
  • People
Members Only Content

Hot Read: GMP in Practice

Oct 1, 2018
  • Quality & Regulatory

Exciting New Changes are Coming to Pharma

Oct 1, 2018
  • Manufacturing Science
Members Only Content

Pharmacy Student Sees Future of Pharma in Berlin

Oct 1, 2018
  • People
Members Only Content

Risk-Benefit Analysis More of NCA Scope

Oct 1, 2018
  • Quality & Regulatory
Members Only Content

New Perspectives on Freeze-Drying

Oct 1, 2018
  • Biopharmaceuticals & Biotechnology

Southeast Chapter Meeting Pairs Wine, Decon Tech

Oct 1, 2018
  • People
Members Only Content

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
Members Only Content

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
Members Only Content

Going Beyond Patient Preference

Aug 27, 2018
  • Manufacturing Science

What Annex 1 Means for Sterilization and Moist Steam

Aug 27, 2018
  • Aseptic Processing & Sterilization
Members Only Content

Drug Delivery Combination Products Go “Viral”

Aug 27, 2018
  • Quality & Regulatory

Draft Annex 1 Separates Cleaning and Disinfection

Aug 27, 2018
  • Aseptic Processing & Sterilization
Members Only Content

Biologics Packaging Presents Risks

Aug 27, 2018
  • Manufacturing Science
Members Only Content

Data Integrity in the Age of Metadata and Big Data

Aug 27, 2018
  • Quality & Regulatory
Members Only Content

Revised USP Micro Chapters Address Changing Technologies

Aug 27, 2018
  • Aseptic Processing & Sterilization
Members Only Content

A Wealth of New Micro Regulations

Aug 27, 2018
  • Quality & Regulatory
Members Only Content

Strategies to Address E/L Container Closure Challenges

Aug 23, 2018
  • Quality & Regulatory

Industry Converges on Pharmacopeial Convergence

Aug 21, 2018
  • Quality & Regulatory
Members Only Content

India Chapter Goes into the Cold

Aug 14, 2018
  • People
Members Only Content

Visual Inspection Workshop Addresses Annex 1, New Tech

Aug 7, 2018
  • Manufacturing Science
Members Only Content

Russian GMP Inspections Present Challenges, Opportunities: Part II

Jul 31, 2018
  • Quality & Regulatory
Members Only Content

Russian GMP Inspections Present Challenges, Opportunities: Part I

Jul 31, 2018
  • Quality & Regulatory
Members Only Content

Not So Different After All

Jul 24, 2018
  • People

Reclaiming Efficiency Amid Serialization Nightmares

Jul 24, 2018
  • Supply Chain & Outsourcing
Members Only Content

Evaluating Cell Viability After Cryopreservation

Jul 17, 2018
  • Biopharmaceuticals & Biotechnology
Members Only Content

PDA Participates in Nipro Experience Days

Jul 17, 2018
  • People
Members Only Content

New Serialization Regs Impact Global Pharma

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

2018 PDA Summer Reading

Jul 9, 2018
  • People
Members Only Content

A Risk-Based Approach to Supplier Management

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

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
Members Only Content

A Not-So-Sweet Smell: Part II

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

Quality/Compliance Management for Virtual Companies

Jul 9, 2018
  • Quality & Regulatory
Members Only Content

Five Critical Endotoxin Testing Concerns

Jul 9, 2018
  • Aseptic Processing & Sterilization
Members Only Content

Opportunities to Build and Grow Your Network

Jul 9, 2018
  • People

Visual Inspection Remains Critical

Jul 9, 2018
  • Quality & Regulatory
Members Only Content

How to Best Tackle Biosimilar Challenges

Jul 9, 2018
  • Biopharmaceuticals & Biotechnology

3 Questions for Biogen’s Amy Wilson

Jun 25, 2018
  • Manufacturing Science
Members Only Content

Pharma Must Work “Smarter” in New Era

Jun 19, 2018
  • Manufacturing Science
Members Only Content

Chapter Grows Professional Opportunities Across Industry

Jun 5, 2018
  • People
Members Only Content

Prospects for Post-Approval Change Management

May 29, 2018
  • Quality & Regulatory
Members Only Content

Eyeing the Future of Biomanufacturing

May 29, 2018
  • People
Members Only Content

A Not-So-Sweet Smell: Part I

May 29, 2018
  • Supply Chain & Outsourcing
Members Only Content

Can ICH Q12 Unlock Manufacturing Innovation?

May 29, 2018
  • Quality & Regulatory
Members Only Content

Growing Acceptance of Real-Time Monitoring

May 29, 2018
  • Aseptic Processing & Sterilization

Seeing the Light

May 29, 2018
  • Quality & Regulatory
Members Only Content

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
Members Only Content

A Tale of Two Vials

May 7, 2018
  • Manufacturing Science
Members Only Content

3-D Printing and Biopharmaceutical Manufacturing

Apr 30, 2018
  • Manufacturing Science
  • Members Only
Members Only Content

Strategies for Reducing Data Integrity Challenges

Apr 30, 2018
  • Quality & Regulatory
Members Only Content

PDA Responds to Annex 1 Revision

Apr 30, 2018
  • Quality & Regulatory

Container Closure Integrity Requires Adaptation

Apr 30, 2018
  • Quality & Regulatory
Members Only Content

RMAT Program Raises a Few Questions

Apr 30, 2018
  • Biopharmaceuticals & Biotechnology
Members Only Content

Make New Buddies in Berlin

Apr 30, 2018
  • People

Running the Numbers for Analytical Similarity

Apr 30, 2018
  • Quality & Regulatory
Members Only Content

Amgen Team Brings Expertise to Taiwan Chapter

Apr 30, 2018
  • People
Members Only Content

Glass Versus Cyclic Olefin Polymers

Apr 25, 2018
  • Manufacturing Science
Members Only Content

New Drugs Need Agile Biomanufacturing

Apr 17, 2018
  • Manufacturing Science
Members Only Content

Speaking the Language of GMP

Apr 3, 2018
  • Biopharmaceuticals & Biotechnology
Members Only Content

Packaging Critical to Success of Drug Products

Apr 2, 2018
  • Quality & Regulatory
Members Only Content

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
Members Only Content

Cell and Gene Therapies Present Challenges, Promise

Apr 2, 2018
  • Biopharmaceuticals & Biotechnology
Members Only Content

Volunteering Opens Doors for Student Chapter

Apr 2, 2018
  • People
Members Only Content

Sterilizing Grade Filters and PUPSIT

Mar 28, 2018
  • Aseptic Processing & Sterilization
Members Only Content

Novel Manufacturing Tech Drives Novel Product Development

Mar 20, 2018
  • Manufacturing Science
Members Only Content

Glass Along the Value Chain

Mar 13, 2018
  • Manufacturing Science
Members Only Content

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