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  • A Risk Assessment is an Opportunity Assessment

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  • PDA and IFPMA Foster Discussion on PAC

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  • Two Views on Packaging from Prefilled Exhibitors

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  • Five Keys to Manufacturing Success

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  • One Company’s Approach to Rapid Micro Methods

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  • Ireland Chapter Provides Once in a Lifetime Trip

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  • New Realities for Prefilled Syringes

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  • Industry Awaits Annex 1 Revision

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  • The QC Lab of the Future

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  • Novel Drug Products Drive New Views on Suitability

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  • Visual Inspection Faces Changing Environment

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  • One Simple Way to Manage Aseptic Risk Assessments

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  • Company Sees Success With Automated Endotoxin Testing

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  • Four Steps to Ensuring Data Integrity for BET

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  • Why the Surface is Critical to Disinfection Testing

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  • PQS: An Effective Lever for Managing PACs

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  • The Future of Cell and Gene Therapies is Here

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  • The Cost of Microbial Control

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  • A Stepwise Approach to Effective Data Management and Analysis

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  • Women in Biotech Panel Offers Career Advice for All Sexes

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  • India Chapter Holds Successful Biologics Workshop

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  • Difficult-to-Inspect Drugs Require New Processes

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  • When Microbiologists Collaborate, Great Things Happen

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  • Can Single-Use Components Be Commodities?

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  • Regulatory Submissions: No Longer Paper-Based

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  • Build Your Network at the PDA/FDA JRC

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  • OPQ Establishes Manufacturing Science CoE

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  • PDA Summer Reading for 2017

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  • A Maturing Model of Quality

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  • Industry Expert Weighs in on Quality Metrics

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

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  • PDA’s 4th Metrics Conference

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  • PQRI Establishes Thresholds for L&E Identification

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  • Knowledge is Power

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  • Perspectives on Packaging

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  • Industry Experts: Quality Requires Proactive Approach

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  • The Future of Glass in Parenteral Packaging

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  • New Guidance for Visual Inspection Available

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  • Gowning Requirement for Blow-Fill-Seal Technology

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  • MAbs Require Ongoing Dialogue

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  • Prefilled Syringes Bring Patient to the Forefront

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  • Microbiologists Put Under the Microscope

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  • How to Use QbD to Select Packaging Components

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  • Putting the Pieces Together

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  • Creating a Global Incentive for Pharma

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  • Lower the H202 Concentrations in Your Isolator with One Easy Upgrade

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

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  • Pharma Has its Head in the Cloud

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  • Cost of Quality Still a Factor

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  • Buddy Up in Berlin with New PDA Pals

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  • Regulators, USP Taking a Close Look at Visual Inspection

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  • A Case Study in Aseptic Gas Plasma Decontamination

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  • Japan Chapter Marks 25 Years at Annual Event

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  • Human Element Key to Digital Transformation

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  • A QUICK Guide To Selecting a CMO

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  • IG Meetings to Address Complexity of New Products

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  • How to Get Your ATMP From the Lab to the Market

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  • Viral Safety Approaches for Advanced Therapy Medicinal Products

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  • WHO Should Align with ICH on PACs

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  • Validation for Automated Washing Systems

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  • Data Integrity Event Draws Largest Attendance Ever

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  • Quality Metrics to Impact Different Pharma Sectors

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  • Leveraging Video to Improve Operations

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  • Reaching for Next Gen Biopharma Manufacturing

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  • PDA/FDA JRC to Explore Current FDA Thinking

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  • Group Seeks “ADDoPTion” of Digital Design

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  • Translate Your Knowledge into Reliability

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  • Make Sunny Memories at the 2017 PDA Annual Meeting

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  • A Case Study in Real-Time Release Testing

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  • A Trending Policy for Automated Visual Inspection

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  • Could Big Data Lead to Big Industry Changes?

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  • Chapter Learns about EU and US Regs from Experts

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  • PDA Prefilled Conference Highlights Device Complexity

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  • Storm Surrounds Clinical Trial Data in China

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  • Changing Currents

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  • The New Annex 16 – Eight Questions for Rainer Gnibl

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  • Chapter’s Media Fill Workshops a Resounding Success

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  • Water Types and Microbial Contamination/Biofilm Generation

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  • PDA Supports Non-Distillation WFI Methods

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  • Requirements after “Opening” a Water System

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  • Chapter Gets Hands-On Cold Chain Experience

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  • Non-Distillation WFI Opens Door for Greater Efficiency

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  • A New Process for Reducing Glass Breakage

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  • Annex 1 Showcases the Need for Clear Guidance

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  • CMC Strategy: A Critical Foundation for Biosimilars

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  • PAC Challenges for Biosimilar Sponsors

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  • SE Chapter Awards Scholarships to Sci/Tech Students

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  • A New Method for Streamlining Media Fills

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  • Notes from the First PDA Biosimilar Conference

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  • Establishing a Formalized Risk Assessment for Excipients

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  • PDA/FDA JRC: The Past, Present, and Future of QA

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  • PDA/FDA JRC: Building a Culture of Quality

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  • UK Chapter Explores Technology Transfer Requirements

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  • GMP Oversight of Medicines Manufacturers in the European Union

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  • New Committee Fosters Support for Vendors in Europe

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  • Personalized Meds: There’s Something for Everyone

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  • USP Perspectives on LAL Assay Interference and NOE Standard

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  • How Global Orgs Can Achieve Process Validation Success

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  • Anticounterfeiting Rules Add to Complexity of Global Regs

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  • PIC/S and ICH Reps Talk Global Pharma at PDA/FDA JRC

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  • Some Thoughts on USP’s New NOE Standard

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  • Brazil Chapter Approved; First in South America for PDA

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  • Four Global Pharma Concerns in an Expanding World

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  • Latin America: Moving from Importer to Exporter

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  • Commentary – PDA’s Metrics Activities

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  • When a Routine Trip Becomes a 1980s Comedy of Errors

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

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  • PDA Program to Address Post-Approval Hurdles

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  • When Data Integrity Takes Front and Center Stage

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  • Three Questions for MHRA’s David Churchward

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  • Four Steps to Conducting a Successful Data Integrity Audit

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

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  • Data Integrity and the Preapproval Inspection

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

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  • Drug Shortage is a "Wicked Problem"

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