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Parenteral Drug Association
Connecting People, Science and Regulation
®
Parenteral Drug Association
Connecting People, Science and Regulation
®
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Quality & Regulatory
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You Had Micro Questions, FDA Had Big Answers
Marilyn L. Foster, PDA
May 4, 2022
Quality & Regulatory
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Merck Streamlines Quality Management with the Cloud
Mike Jovanis, Vice President of Vault Quality at Veeva Systems
Apr 20, 2022
Manufacturing Science
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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
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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
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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
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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
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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
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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
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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
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Southeast Chapter Meeting Pairs Wine, Decon Tech
Oct 1, 2018
People
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Standing Guard
Sep 26, 2018
Aseptic Processing & Sterilization
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Endotoxin Testing Using Recombinant Reagents
Sep 18, 2018
Aseptic Processing & Sterilization
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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
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Does QRM + RMM = Better EM?
Sep 4, 2018
Aseptic Processing & Sterilization
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Build Connections at Two PDA Events
Aug 27, 2018
People
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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
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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
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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
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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
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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
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Blockchain: Will it Transform the Pharmaceutical Supply Chain?
Jul 9, 2018
Supply Chain & Outsourcing
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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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Quality/Compliance Management for Virtual Companies
Jul 9, 2018
Quality & Regulatory
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Five Critical Endotoxin Testing Concerns
Jul 9, 2018
Aseptic Processing & Sterilization
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Opportunities to Build and Grow Your Network
Jul 9, 2018
People
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Visual Inspection Remains Critical
Jul 9, 2018
Quality & Regulatory
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How to Best Tackle Biosimilar Challenges
Jul 9, 2018
Biopharmaceuticals & Biotechnology
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3 Questions for Biogen’s Amy Wilson
Jun 25, 2018
Manufacturing Science
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Pharma Must Work “Smarter” in New Era
Jun 19, 2018
Manufacturing Science
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Chapter Grows Professional Opportunities Across Industry
Jun 5, 2018
People
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Prospects for Post-Approval Change Management
May 29, 2018
Quality & Regulatory
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Eyeing the Future of Biomanufacturing
May 29, 2018
People
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A Not-So-Sweet Smell: Part I
May 29, 2018
Supply Chain & Outsourcing
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Can ICH Q12 Unlock Manufacturing Innovation?
May 29, 2018
Quality & Regulatory
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Growing Acceptance of Real-Time Monitoring
May 29, 2018
Aseptic Processing & Sterilization
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Seeing the Light
May 29, 2018
Quality & Regulatory
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Getting Biosimilars Right the First Time
May 29, 2018
Biopharmaceuticals & Biotechnology
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Knowledge Grows for mAb Development
May 29, 2018
Biopharmaceuticals & Biotechnology
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A Wealth of New Tech Possibilities
May 16, 2018
Manufacturing Science
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A Tale of Two Vials
May 7, 2018
Manufacturing Science
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3-D Printing and Biopharmaceutical Manufacturing
Apr 30, 2018
Manufacturing Science
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Strategies for Reducing Data Integrity Challenges
Apr 30, 2018
Quality & Regulatory
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PDA Responds to Annex 1 Revision
Apr 30, 2018
Quality & Regulatory
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Container Closure Integrity Requires Adaptation
Apr 30, 2018
Quality & Regulatory
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RMAT Program Raises a Few Questions
Apr 30, 2018
Biopharmaceuticals & Biotechnology
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Make New Buddies in Berlin
Apr 30, 2018
People
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Running the Numbers for Analytical Similarity
Apr 30, 2018
Quality & Regulatory
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Amgen Team Brings Expertise to Taiwan Chapter
Apr 30, 2018
People
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Glass Versus Cyclic Olefin Polymers
Apr 25, 2018
Manufacturing Science
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New Drugs Need Agile Biomanufacturing
Apr 17, 2018
Manufacturing Science
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Speaking the Language of GMP
Apr 3, 2018
Biopharmaceuticals & Biotechnology
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Packaging Critical to Success of Drug Products
Apr 2, 2018
Quality & Regulatory
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Know Your Numbers for Analytical Similarity
Apr 2, 2018
Biopharmaceuticals & Biotechnology
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PDA Celebrates Ten Years of ATMP Conferences
Apr 2, 2018
People
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ATMPs: What a Difference a Year Can Make
Apr 2, 2018
Quality & Regulatory
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Moving the Patient to the Forefront
Apr 2, 2018
Manufacturing Science
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Cell and Gene Therapies Present Challenges, Promise
Apr 2, 2018
Biopharmaceuticals & Biotechnology
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Volunteering Opens Doors for Student Chapter
Apr 2, 2018
People
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Sterilizing Grade Filters and PUPSIT
Mar 28, 2018
Aseptic Processing & Sterilization
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Novel Manufacturing Tech Drives Novel Product Development
Mar 20, 2018
Manufacturing Science
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Glass Along the Value Chain
Mar 13, 2018
Manufacturing Science
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