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Letter

• Regulatory Concerns Drive New Developments in Glass Packaging
  Jan 2, 2019
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• Data Integrity Validated as Key Issue

  Jan 15, 2019
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• Alternative to LAL Gains Ground

  Jan 8, 2019
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• An Overview of Container Closure Integrity

  Jan 2, 2019
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• Current Perspectives on the Monocyte Activation Test

  Jan 2, 2019
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• Innovative Tech Drives Drug Shortage Solutions

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

  Jan 2, 2019
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• India Chapter Gets Hands-On with CCI Tech

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

  Dec 11, 2018
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• Holistic Verification Requires a New Mindset

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

  Nov 26, 2018
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• Industry 4.0 and Drug Manufacturing

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

  Nov 6, 2018
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• Hidden Contamination in Starting Materials

  Nov 6, 2018
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• Process, Interrupted

  Nov 6, 2018
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• Thanks for the Warning Letter: Part I

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

  Nov 5, 2018
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• Glass Breakage in Pharmaceutical Packaging

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

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

  Nov 5, 2018
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• Modular Manufacturing Begins to Take Hold

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

  Oct 22, 2018
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• Future Challenges in Visual Inspection Processes

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

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

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

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

  Oct 1, 2018
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• Hot Read: GMP in Practice

  Oct 1, 2018
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• Exciting New Changes are Coming to Pharma

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

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

  Oct 1, 2018
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• New Perspectives on Freeze-Drying

  Oct 1, 2018
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• Southeast Chapter Meeting Pairs Wine, Decon Tech

  Oct 1, 2018
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• Standing Guard

  Sep 26, 2018
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• Endotoxin Testing Using Recombinant Reagents

  Sep 18, 2018
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• A Deep Dive into Pharmacopeial Harmonization

  Sep 11, 2018
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• Deep Learning in the Information Swamp

  Sep 11, 2018
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• Does QRM + RMM = Better EM?

  Sep 4, 2018
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• Build Connections at Two PDA Events

  Aug 27, 2018
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• New Trends, New Challenges for BET

  Aug 27, 2018
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• Going Beyond Patient Preference

  Aug 27, 2018
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• What Annex 1 Means for Sterilization and Moist Steam

  Aug 27, 2018
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• Drug Delivery Combination Products Go “Viral”

  Aug 27, 2018
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• Draft Annex 1 Separates Cleaning and Disinfection

  Aug 27, 2018
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• Biologics Packaging Presents Risks

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

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

  Aug 27, 2018
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• A Wealth of New Micro Regulations

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

  Aug 23, 2018
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• Industry Converges on Pharmacopeial Convergence

  Aug 21, 2018
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• India Chapter Goes into the Cold

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

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

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

  Jul 31, 2018
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• Not So Different After All

  Jul 24, 2018
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• Reclaiming Efficiency Amid Serialization Nightmares

  Jul 24, 2018
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• Evaluating Cell Viability After Cryopreservation

  Jul 17, 2018
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• PDA Participates in Nipro Experience Days

  Jul 17, 2018
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• New Serialization Regs Impact Global Pharma

  Jul 9, 2018
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• 2018 PDA Summer Reading

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

  Jul 9, 2018
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• Viscous Product No Match for New CCI Tech

  Jul 9, 2018
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• Blockchain: Will it Transform the Pharmaceutical Supply Chain?

  Jul 9, 2018
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• Are You Ready for the eCTD Mandate?

  Jul 9, 2018
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• A Not-So-Sweet Smell: Part II

  Jul 9, 2018
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• Quality/Compliance Management for Virtual Companies

  Jul 9, 2018
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• Five Critical Endotoxin Testing Concerns

  Jul 9, 2018
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• Opportunities to Build and Grow Your Network

  Jul 9, 2018
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• Visual Inspection Remains Critical

  Jul 9, 2018
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• How to Best Tackle Biosimilar Challenges

  Jul 9, 2018
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• 3 Questions for Biogen’s Amy Wilson

  Jun 25, 2018
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• Pharma Must Work “Smarter” in New Era

  Jun 19, 2018
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• Chapter Grows Professional Opportunities Across Industry

  Jun 5, 2018
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• Prospects for Post-Approval Change Management

  May 29, 2018
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• Eyeing the Future of Biomanufacturing

  May 29, 2018
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• A Not-So-Sweet Smell: Part I

  May 29, 2018
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• Can ICH Q12 Unlock Manufacturing Innovation?

  May 29, 2018
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• Growing Acceptance of Real-Time Monitoring

  May 29, 2018
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• Seeing the Light

  May 29, 2018
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• Getting Biosimilars Right the First Time

  May 29, 2018
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• Knowledge Grows for mAb Development

  May 29, 2018
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• A Wealth of New Tech Possibilities

  May 16, 2018
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• A Tale of Two Vials

  May 7, 2018
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• 3-D Printing and Biopharmaceutical Manufacturing

  Apr 30, 2018
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• Strategies for Reducing Data Integrity Challenges

  Apr 30, 2018
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• PDA Responds to Annex 1 Revision

  Apr 30, 2018
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• Container Closure Integrity Requires Adaptation

  Apr 30, 2018
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• RMAT Program Raises a Few Questions

  Apr 30, 2018
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• Make New Buddies in Berlin

  Apr 30, 2018
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• Running the Numbers for Analytical Similarity

  Apr 30, 2018
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• Amgen Team Brings Expertise to Taiwan Chapter

  Apr 30, 2018
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• Glass Versus Cyclic Olefin Polymers

  Apr 25, 2018
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• New Drugs Need Agile Biomanufacturing

  Apr 17, 2018
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• Speaking the Language of GMP

  Apr 3, 2018
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• Packaging Critical to Success of Drug Products

  Apr 2, 2018
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• Know Your Numbers for Analytical Similarity

  Apr 2, 2018
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• PDA Celebrates Ten Years of ATMP Conferences

  Apr 2, 2018
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• ATMPs: What a Difference a Year Can Make

  Apr 2, 2018
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• Moving the Patient to the Forefront

  Apr 2, 2018
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• Cell and Gene Therapies Present Challenges, Promise

  Apr 2, 2018
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• Volunteering Opens Doors for Student Chapter

  Apr 2, 2018
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• Sterilizing Grade Filters and PUPSIT

  Mar 28, 2018
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• Novel Manufacturing Tech Drives Novel Product Development

  Mar 20, 2018
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• Glass Along the Value Chain

  Mar 13, 2018
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• Awareness Critical for Container Closure Components

  Mar 6, 2018
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• Honoring PDA’s Female Volunteer Leaders

  Feb 26, 2018
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• Smoke Signals

  Feb 26, 2018
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• New Approach Suggests Continuous Lyophilization is Possible

  Feb 26, 2018
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• PDA Staff Try a Hand at Aseptic Processing

  Feb 26, 2018
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• Seeing the Hidden

  Feb 26, 2018
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• Korea Chapter Inaugurates New KPDA Hall

  Feb 26, 2018
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• H20 Requirements for Superheated Sterilization

  Feb 26, 2018
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• Changes to USP Council of Experts

  Feb 26, 2018
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• New Tech Disrupts Traditional Aseptic Processing

  Feb 20, 2018
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• Adapt Your Nest-and-Tub System as the Industry Evolves

  Feb 13, 2018
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• New Trends Require Investment from Vaccine Makers

  Feb 6, 2018
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• High Regulatory Expectations for Biosimilars

  Jan 30, 2018
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• More Opportunities to Grow Your Network

  Jan 29, 2018
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• Teamwork Crucial to SUS Sterilization Validation

  Jan 29, 2018
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• Formalizing a Risk Assessment for Excipients

  Jan 29, 2018
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• PDA Prefilled Syringes Exhibition Draws Crowd

  Jan 29, 2018
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• Extractables Testing of Aluminosilicate and Borosilicate Glass Containers

  Jan 29, 2018
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• Student Chapter Shows Enthusiasm for Industry

  Jan 29, 2018
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• 4 Capabilities to Operationalizing Resilience

  Jan 29, 2018
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• Achieve True Manufacturing Reliability

  Jan 23, 2018
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• Chapter Learns About Future of Facility Design

  Jan 16, 2018
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• Quality and Innovation are Not Incompatible

  Jan 9, 2018
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• Quality: One Question, Many Answers

  Jan 9, 2018
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• Collaboration Through Mutual Reliance Brings FDA and EMA to the Table

  Jan 2, 2018
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• Monitor Viable Air with Single-Use, Real-Time Tech

  Jan 2, 2018
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• Disruptive Change is on the Horizon

  Jan 2, 2018
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• Flexibility Needed for PAC

  Jan 2, 2018
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• Regulators Tackle Tough Micro Questions on Panel

  Jan 2, 2018
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• New PDA Task Force Targets Big Data

  Dec 13, 2017
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• Brazil Chapter Offers Hands-On Aseptic Training

  Dec 5, 2017
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• Cracking the Challenges of Glass Packaging

  Nov 28, 2017
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• Millennials: How Manufacturers are Training the Next Generation

  Nov 6, 2017
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• Record Scholarships Awarded at NE Chapter Dinner

  Nov 6, 2017
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• CFDA Encouraged to Review PDA Docs

  Nov 6, 2017
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• PDA Staff Gown Up for Site Visit at Pilot Plant

  Nov 6, 2017
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• PDA on the Move

  Nov 6, 2017
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• Worst-Case Analysis of Cell Growth in SUS

  Nov 6, 2017
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• Networking Lights Up PDA/FDA JRC Exhibit Hall

  Nov 6, 2017
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• Isolator Surfaces and Contamination Risks to Personnel

  Nov 6, 2017
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• AIDC is a Sign of Things to Come: Part II

  Oct 31, 2017
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• AIDC is a Sign of Things to Come: Part I

  Oct 31, 2017
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• A Risk Assessment is an Opportunity Assessment

  Oct 18, 2017
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• PDA and IFPMA Foster Discussion on PAC

  Oct 10, 2017
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• Prefilled Syringe Manufacturing Moves Away from Hands-On Approach

  Oct 3, 2017
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• Two Views on Packaging from Prefilled Exhibitors

  Oct 3, 2017
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• Five Keys to Manufacturing Success

  Oct 3, 2017
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• One Company’s Approach to Rapid Micro Methods

  Oct 3, 2017
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• Ireland Chapter Provides Once in a Lifetime Trip

  Oct 3, 2017
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• New Realities for Prefilled Syringes

  Sep 27, 2017
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• Industry Awaits Annex 1 Revision

  Sep 19, 2017
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• The QC Lab of the Future

  Sep 13, 2017
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• Novel Drug Products Drive New Views on Suitability

  Aug 29, 2017
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• Visual Inspection Faces Changing Environment

  Aug 29, 2017
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• One Simple Way to Manage Aseptic Risk Assessments

  Aug 29, 2017
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• Company Sees Success With Automated Endotoxin Testing

  Aug 29, 2017
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• Four Steps to Ensuring Data Integrity for BET

  Aug 29, 2017
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• Why the Surface is Critical to Disinfection Testing

  Aug 29, 2017
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• PQS: An Effective Lever for Managing PACs

  Aug 22, 2017
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• The Future of Cell and Gene Therapies is Here

  Aug 15, 2017
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• The Cost of Microbial Control

  Aug 8, 2017
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• A Stepwise Approach to Effective Data Management and Analysis

  Jul 25, 2017
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• Women in Biotech Panel Offers Career Advice for All Sexes

  Jul 18, 2017
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• India Chapter Holds Successful Biologics Workshop

  Jul 10, 2017
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• Difficult-to-Inspect Drugs Require New Processes

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