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  • Biopharmaceuticals & Biotechnology

CBER Continues to Analyze Next-Gen Sequencing

  • Rebecca Stauffer, PDA
  • Jul 9, 2020
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  • Supply Chain & Outsourcing

Pharma Firm Explores RFID for Prefilled Syringes

  • Gabriele Peron, Stevanato Group
  • Jun 23, 2020
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  • Quality & Regulatory

Regulator Develops Remote Inspection Process Due to Pandemic

  • Vladislav Shestakov, Russian State Institute of Drugs and Good Practices, and Elizabeth Meyers, Amgen
  • Jun 9, 2020
  • Article Categories

Chapter Learns About Future of Facility Design

Jan 16, 2018
  • People
Members Only Content

Quality and Innovation are Not Incompatible

Jan 9, 2018
  • Quality & Regulatory
Members Only Content

Quality: One Question, Many Answers

Jan 9, 2018
  • Quality & Regulatory
Members Only Content

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
Members Only Content

New PDA Task Force Targets Big Data

Dec 13, 2017
  • Manufacturing Science

Brazil Chapter Offers Hands-On Aseptic Training

Dec 5, 2017
  • People
Members Only Content

Cracking the Challenges of Glass Packaging

Nov 28, 2017
  • Quality & Regulatory

Millennials: How Manufacturers are Training the Next Generation

Nov 6, 2017
  • People
Members Only Content

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
Members Only Content

Isolator Surfaces and Contamination Risks to Personnel

Nov 6, 2017
  • Aseptic Processing & Sterilization
Members Only Content

AIDC is a Sign of Things to Come: Part II

Oct 31, 2017
  • Supply Chain & Outsourcing
Members Only Content

AIDC is a Sign of Things to Come: Part I

Oct 31, 2017
  • Supply Chain & Outsourcing
Members Only Content

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
Members Only Content

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
Members Only Content

One Company’s Approach to Rapid Micro Methods

Oct 3, 2017
  • Aseptic Processing & Sterilization
Members Only Content

Ireland Chapter Provides Once in a Lifetime Trip

Oct 3, 2017
  • People
Members Only Content

New Realities for Prefilled Syringes

Sep 27, 2017
  • Quality & Regulatory

Industry Awaits Annex 1 Revision

Sep 19, 2017
  • Quality & Regulatory
Members Only Content

The QC Lab of the Future

Sep 13, 2017
  • Manufacturing Science
Members Only Content

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
Members Only Content

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
Members Only Content

Why the Surface is Critical to Disinfection Testing

Aug 29, 2017
  • Aseptic Processing & Sterilization
Members Only Content

PQS: An Effective Lever for Managing PACs

Aug 22, 2017
  • Quality & Regulatory

The Future of Cell and Gene Therapies is Here

Aug 15, 2017
  • Biopharmaceuticals & Biotechnology

The Cost of Microbial Control

Aug 8, 2017
  • Aseptic Processing & Sterilization

A Stepwise Approach to Effective Data Management and Analysis

Jul 25, 2017
  • Aseptic Processing & Sterilization

Women in Biotech Panel Offers Career Advice for All Sexes

Jul 18, 2017
  • People

India Chapter Holds Successful Biologics Workshop

Jul 10, 2017
  • People
Members Only Content

Difficult-to-Inspect Drugs Require New Processes

Jul 10, 2017
  • Biopharmaceuticals & Biotechnology

When Microbiologists Collaborate, Great Things Happen

Jul 10, 2017
  • Aseptic Processing & Sterilization

Can Single-Use Components Be Commodities?

Jul 10, 2017
  • Manufacturing Science
Members Only Content

Regulatory Submissions: No Longer Paper-Based

Jul 10, 2017
  • Quality & Regulatory
Members Only Content

Build Your Network at the PDA/FDA JRC

Jul 10, 2017
  • People

OPQ Establishes Manufacturing Science CoE

Jul 10, 2017
  • Quality & Regulatory

PDA Summer Reading for 2017

Jul 10, 2017
  • People
Members Only Content

A Maturing Model of Quality

Jul 10, 2017
  • Quality & Regulatory

Industry Expert Weighs in on Quality Metrics

Jul 10, 2017
  • Quality & Regulatory

U.S., UK Regulators Share Passion for Quality Culture

Jul 10, 2017
  • Quality & Regulatory
Members Only Content

PDA’s 4th Metrics Conference

Jul 10, 2017
  • Quality & Regulatory
Members Only Content

PQRI Establishes Thresholds for L&E Identification

Jun 27, 2017
  • Manufacturing Science
Members Only Content

Knowledge is Power

Jun 13, 2017
  • Supply Chain & Outsourcing

Perspectives on Packaging

Jun 8, 2017
  • Manufacturing Science

Industry Experts: Quality Requires Proactive Approach

May 30, 2017
  • Quality & Regulatory

The Future of Glass in Parenteral Packaging

May 30, 2017
  • Manufacturing Science
Members Only Content

New Guidance for Visual Inspection Available

May 30, 2017
  • Quality & Regulatory

Gowning Requirement for Blow-Fill-Seal Technology

May 30, 2017
  • Aseptic Processing & Sterilization
Members Only Content

MAbs Require Ongoing Dialogue

May 30, 2017
  • Biopharmaceuticals & Biotechnology

Prefilled Syringes Bring Patient to the Forefront

May 30, 2017
  • Manufacturing Science

Microbiologists Put Under the Microscope

May 30, 2017
  • People
Members Only Content

How to Use QbD to Select Packaging Components

May 30, 2017
  • Quality & Regulatory

Putting the Pieces Together

May 30, 2017
  • Manufacturing Science

Creating a Global Incentive for Pharma

May 23, 2017
  • Quality & Regulatory

Lower the H202 Concentrations in Your Isolator with One Easy Upgrade

May 2, 2017
  • Aseptic Processing & Sterilization
Members Only Content

Hear From Industry, FDA Leaders on the Issues of the Day

May 2, 2017
  • Quality & Regulatory

Pharma Has its Head in the Cloud

May 1, 2017
  • Manufacturing Science
Members Only Content

Cost of Quality Still a Factor

May 1, 2017
  • Quality & Regulatory
Members Only Content

Buddy Up in Berlin with New PDA Pals

May 1, 2017
  • People

Regulators, USP Taking a Close Look at Visual Inspection

May 1, 2017
  • Quality & Regulatory

A Case Study in Aseptic Gas Plasma Decontamination

May 1, 2017
  • Aseptic Processing & Sterilization
Members Only Content

Japan Chapter Marks 25 Years at Annual Event

May 1, 2017
  • People
Members Only Content

Human Element Key to Digital Transformation

Apr 25, 2017
  • Manufacturing Science

A QUICK Guide To Selecting a CMO

Apr 18, 2017
  • Quality & Regulatory
Members Only Content

IG Meetings to Address Complexity of New Products

Apr 4, 2017
  • Quality & Regulatory

How to Get Your ATMP From the Lab to the Market

Apr 4, 2017
  • Biopharmaceuticals & Biotechnology
Members Only Content

Viral Safety Approaches for Advanced Therapy Medicinal Products

Apr 4, 2017
  • Biopharmaceuticals & Biotechnology

WHO Should Align with ICH on PACs

Apr 4, 2017
  • Quality & Regulatory

Quality Metrics to Impact Different Pharma Sectors

Mar 14, 2017
  • Quality & Regulatory

Leveraging Video to Improve Operations

Mar 7, 2017
  • Manufacturing Science

Storm Surrounds Clinical Trial Data in China

Feb 7, 2017
  • Quality & Regulatory

Annex 1 Showcases the Need for Clear Guidance

Jan 10, 2017
  • Quality & Regulatory

GMP Oversight of Medicines Manufacturers in the European Union

Nov 14, 2016
  • Quality & Regulatory

When a Routine Trip Becomes a 1980s Comedy of Errors

Oct 4, 2016
  • People
Members Only Content

A Line of Sight Approach for Assessing Aseptic Processing Risk: Part III

Sep 27, 2016
  • Aseptic Processing & Sterilization

PDA Program to Address Post-Approval Hurdles

Aug 24, 2016
  • Quality & Regulatory

When Data Integrity Takes Front and Center Stage

Aug 9, 2016
  • Quality & Regulatory
Members Only Content

Three Questions for MHRA’s David Churchward

Jul 26, 2016
  • Quality & Regulatory
Members Only Content

Four Steps to Conducting a Successful Data Integrity Audit

Jul 19, 2016
  • Quality & Regulatory

A Line of Sight Approach for Assessing Aseptic Processing Risk: Part II

Jul 7, 2016
  • Aseptic Processing & Sterilization

Data Integrity and the Preapproval Inspection

Jun 22, 2016
  • Quality & Regulatory

A Line of Sight Approach for Assessing Aseptic Processing Risk: Part I

May 31, 2016
  • Aseptic Processing & Sterilization

Drug Shortage is a "Wicked Problem"

May 4, 2016
  • Quality & Regulatory

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