• People
• •
• Science
• •
• Regulation

Letter

• U.S. FDA Continues Data Integrity Focus
  Jul 9, 2019
  Read more

Advertisement

• Student Learns Firsthand About Industry

  Aug 12, 2019
  Category:
  • Free
  • People

  • {{Title}} Remove
  Read more

• Exciting Lineup of Speakers at the 2019 PDA/FDA JRC

  Aug 8, 2019
  Category:
  • Free
  • Regulatory

  • {{Title}} Remove
  Read more

• Another Perspective on rFC

  Aug 5, 2019
  Category:
  • Science
  • Members Only

  • {{Title}} Remove
  Read more

• SE Chapter Helps Students Build Bridge to Future

  Jul 29, 2019
  Category:
  • People
  • Free

  • {{Title}} Remove
  Read more

• ISO 22519: A Flawed and Counterproductive Standard

  Jul 23, 2019
  Category:
  • Science
  • Members Only

  • {{Title}} Remove
  Read more

• Ireland Chapter Addresses Annex 1 Revision

  Jul 15, 2019
  Category:
  • People
  • Free

  • {{Title}} Remove
  Read more

• 2019 PDA Summer Reading

  Jul 9, 2019
  Category:
  • Science
  • Members Only

  • {{Title}} Remove
  Read more

• Follow the Audit Trail Breadcrumbs

  Jul 9, 2019
  Category:
  • Regulatory
  • Members Only

  • {{Title}} Remove
  Read more

• New Technology Meets Old Data Integrity Challenges

  Jul 9, 2019
  Category:
  • Regulatory
  • Members Only

  • {{Title}} Remove
  Read more

• Networking Opportunities at 2019 PDA/FDA JRC

  Jul 9, 2019
  Category:
  • Free
  • People

  • {{Title}} Remove
  Read more

• Foreign Particles in Bull’s Eye of Global Reg Agencies

  Jul 9, 2019
  Category:
  • Regulatory
  • Members Only

  • {{Title}} Remove
  Read more

• A Weeklong Look at Quality Risk Management

  Jul 8, 2019
  Category:
  • Regulatory
  • Members Only

  • {{Title}} Remove
  Read more

• Chapter Offers Coffee with PDA President

  Jul 8, 2019
  Category:
  • Members Only
  • People

  • {{Title}} Remove
  Read more

• Future of Packaging on Display at Stevanato Tour

  Jul 8, 2019
  Category:
  • Science
  • Members Only

  • {{Title}} Remove
  Read more

• PDA Comments: Full Support for WHO WFI Guidance

  Jul 8, 2019
  Category:
  • Members Only
  • Regulatory

  • {{Title}} Remove
  Read more

• PDA/FDA JRC Conference Returns!

  Jul 8, 2019
  Category:
  • Regulatory
  • Free

  • {{Title}} Remove
  Read more

• SoCal Student Chapter Keeps Busy

  Jun 24, 2019
  Category:
  • Free
  • People

  • {{Title}} Remove
  Read more

• Excipients' Attributes Crucial for Parenteral Preparations

  Jun 18, 2019
  Category:
  • Members Only
  • Science

  • {{Title}} Remove
  Read more

• More than Volcanoes or Solar System Models

  Jun 10, 2019
  Category:
  • People
  • Free

  • {{Title}} Remove
  Read more

• PDA Comments: Ph. Eur. Tackles Endotoxin Alternative rFC

  May 28, 2019
  Category:
  • Free
  • Regulatory

  • {{Title}} Remove
  Read more

• Aseptic Technology Advances to the Next Level

  May 28, 2019
  Category:
  • Members Only
  • Science

  • {{Title}} Remove
  Read more

• The Role of Project Managers in Pharma

  May 28, 2019
  Category:
  • Free
  • Regulatory

  • {{Title}} Remove
  Read more

• New ISO Standard Available for Water Systems

  May 28, 2019
  Category:
  • Members Only
  • Science

  • {{Title}} Remove
  Read more

• Gloveless Isolators Offer Speedy Throughput

  May 28, 2019
  Category:
  • Science
  • Members Only

  • {{Title}} Remove
  Read more

• U.S. FDA Rep Offers Overview on Visible Particulates

  May 21, 2019
  Category:
  • Regulatory
  • Members Only

  • {{Title}} Remove
  Read more

• Cell and Gene Manufacturing Grows in Singapore

  May 14, 2019
  Category:
  • Free
  • People

  • {{Title}} Remove
  Read more

• Highly Potent APIs: Balancing Patient and Operator Safety

  Apr 29, 2019
  Category:
  • Science
  • Members Only

  • {{Title}} Remove
  Read more

• Robotics and AI Have Much to Offer Pharma

  Apr 29, 2019
  Category:
  • Science
  • Free

  • {{Title}} Remove
  Read more

• PDA Comments: Drug Storage Regulations in Plain Language

  Apr 29, 2019
  Category:
  • Regulatory
  • Free

  • {{Title}} Remove
  Read more

• Rock Out at the 4th PDA Europe Annual Meeting

  Apr 29, 2019
  Category:
  • People
  • Free

  • {{Title}} Remove
  Read more

• The Future of Pharma is Coming to Europe

  Apr 29, 2019
  Category:
  • Science
  • Free

  • {{Title}} Remove
  Read more

• Building an Efficient QRM Strategy

  Apr 29, 2019
  Category:
  • People
  • Members Only

  • {{Title}} Remove
  Read more

• A Patient’s Life Depends on Product Quality

  Apr 22, 2019
  Category:
  • Science
  • Members Only

  • {{Title}} Remove
  Read more

• Air Bubbles versus Transparent Particles

  Apr 9, 2019
  Category:
  • Members Only
  • Science

  • {{Title}} Remove
  Read more

• The Pharmacopeia in the 21st Century

  Apr 1, 2019
  Category:
  • Regulatory
  • Members Only

  • {{Title}} Remove
  Read more

• Future Lies in Continuous Manufacturing Technology

  Apr 1, 2019
  Category:
  • Regulatory
  • Members Only

  • {{Title}} Remove
  Read more

• Deep Dive into Biosimilars Continues

  Apr 1, 2019
  Category:
  • Free
  • Regulatory

  • {{Title}} Remove
  Read more

• B. cepacia: What is it and Why is it a Concern?

  Apr 1, 2019
  Category:
  • Science
  • Members Only

  • {{Title}} Remove
  Read more

• PDA Comments: Viral Testing for Gene Therapies

  Apr 1, 2019
  Category:
  • Regulatory
  • Members Only

  • {{Title}} Remove
  Read more

• Rapid Micro Methods Carry Potential

  Mar 26, 2019
  Category:
  • Science
  • Free

  • {{Title}} Remove
  Read more

• PDA Addresses LER in TR, Forthcoming Book

  Mar 19, 2019
  Category:
  • Science
  • Free

  • {{Title}} Remove
  Read more

• NE Chapter Elects New Board, Plus Cold Storage

  Mar 11, 2019
  Category:
  • People
  • Members Only

  • {{Title}} Remove
  Read more

• Our Data Integrity Journey Has Only Just Begun

  Mar 5, 2019
  Category:
  • Free
  • Regulatory

  • {{Title}} Remove
  Read more

• The Challenges of Visually Inspecting IV Bags

  Feb 26, 2019
  Category:
  • Science
  • Members Only

  • {{Title}} Remove
  Read more

• Implementation Proves Parametric Release Possible

  Feb 25, 2019
  Category:
  • Regulatory
  • Members Only

  • {{Title}} Remove
  Read more

• Viruses on the Surface

  Feb 25, 2019
  Category:
  • Science
  • Members Only

  • {{Title}} Remove
  Read more

• Industry Eyes Future of Visual Inspection

  Feb 25, 2019
  Category:
  • Science
  • Members Only

  • {{Title}} Remove
  Read more

• Big Data is Here to Stay

  Feb 25, 2019
  Category:
  • Members Only
  • Science

  • {{Title}} Remove
  Read more

• Student Chapter Gains Stem Cell Insights

  Feb 25, 2019
  Category:
  • People
  • Members Only

  • {{Title}} Remove
  Read more

• Vaccines, Biosimilars Share Commonalities

  Feb 25, 2019
  Category:
  • Regulatory
  • Members Only

  • {{Title}} Remove
  Read more

• Can the Power of Viruses be Harnessed for Good?

  Feb 18, 2019
  Category:
  • Science
  • Free

  • {{Title}} Remove
  Read more

• Change is in the Air for Packaging Components

  Feb 12, 2019
  Category:
  • Regulatory
  • Members Only

  • {{Title}} Remove
  Read more

• Biopharma Offers New Opportunities

  Feb 5, 2019
  Category:
  • Science
  • Free

  • {{Title}} Remove
  Read more

• A Roadmap to a Continuous Control Strategy

  Jan 28, 2019
  Category:
  • Science
  • Members Only

  • {{Title}} Remove
  Read more

• PUPSIT & the Proposed Annex 1 Revision

  Jan 28, 2019
  Category:
  • Regulatory
  • Members Only

  • {{Title}} Remove
  Read more

• Expand Your Network and Have Fun!

  Jan 28, 2019
  Category:
  • People
  • Free

  • {{Title}} Remove
  Read more

• Thanks for the Warning Letter: Part II

  Jan 28, 2019
  Category:
  • Regulatory
  • Members Only

  • {{Title}} Remove
  Read more

• Response to "Standing Guard"

  Jan 28, 2019
  Category:
  • Science
  • Members Only

  • {{Title}} Remove
  Read more

• Global Regulators Partner for Greater Patient Access

  Jan 28, 2019
  Category:
  • Regulatory
  • Members Only

  • {{Title}} Remove
  Read more

• Take Cell and Gene Therapy Supply Challenges by the Horn

  Jan 28, 2019
  Category:
  • Science
  • Members Only

  • {{Title}} Remove
  Read more

• Are You Up to Speed with Pharma’s Evolving Landscape?

  Jan 28, 2019
  Category:
  • Science
  • Free

  • {{Title}} Remove
  Read more

• Growth Promotion Testing For EM

  Jan 22, 2019
  Category:
  • Free
  • Science

  • {{Title}} Remove
  Read more

• Data Integrity Validated as Key Issue

  Jan 15, 2019
  Category:
  • Free
  • People

  • {{Title}} Remove
  Read more

• Alternative to LAL Gains Ground

  Jan 8, 2019
  Category:
  • Members Only
  • Science

  • {{Title}} Remove
  Read more

• Regulatory Concerns Drive New Developments in Glass Packaging

  Jan 2, 2019
  Category:
  • Regulatory
  • Members Only

  • {{Title}} Remove
  Read more

• An Overview of Container Closure Integrity

  Jan 2, 2019
  Category:
  • Members Only
  • Science

  • {{Title}} Remove
  Read more

• Current Perspectives on the Monocyte Activation Test

  Jan 2, 2019
  Category:
  • Science
  • Members Only

  • {{Title}} Remove
  Read more

• Innovative Tech Drives Drug Shortage Solutions

  Jan 2, 2019
  Category:
  • Regulatory
  • Members Only

  • {{Title}} Remove
  Read more

• Are You (and Pharma) Ready for the Future?

  Jan 2, 2019
  Category:
  • Science
  • Free

  • {{Title}} Remove
  Read more

• India Chapter Gets Hands-On with CCI Tech

  Dec 17, 2018
  Category:
  • Members Only
  • People

  • {{Title}} Remove
  Read more

• EMA's Amsterdam Move Reflects Larger Trend

  Dec 11, 2018
  Category:
  • Regulatory
  • Free

  • {{Title}} Remove
  Read more

• Holistic Verification Requires a New Mindset

  Dec 3, 2018
  Category:
  • Members Only
  • Regulatory

  • {{Title}} Remove
  Read more

• Industry and Regulators Convene to Address Vaccines Challenges

  Nov 26, 2018
  Category:
  • Science

  • {{Title}} Remove
  Read more

• Industry 4.0 and Drug Manufacturing

  Nov 12, 2018
  Category:
  • Science
  • Members Only

  • {{Title}} Remove
  Read more

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

  Nov 6, 2018
  Category:
  • Regulatory
  • Members Only

  • {{Title}} Remove
  Read more

• Hidden Contamination in Starting Materials

  Nov 6, 2018
  Category:
  • Science
  • Members Only

  • {{Title}} Remove
  Read more

• Process, Interrupted

  Nov 6, 2018
  Category:
  • Science
  • Members Only

  • {{Title}} Remove
  Read more

• Thanks for the Warning Letter: Part I

  Nov 6, 2018
  Category:
  • Regulatory
  • Members Only

  • {{Title}} Remove
  Read more

• Reconstitution and Storage Times for Lyo Products

  Nov 5, 2018
  Category:
  • Science
  • Members Only

  • {{Title}} Remove
  Read more

• Glass Breakage in Pharmaceutical Packaging

  Nov 5, 2018
  Category:
  • Science
  • Members Only

  • {{Title}} Remove
  Read more

• Risk Management Shines Light on ICH Q12 Use for Biologics

  Nov 5, 2018
  Category:
  • Regulatory
  • Members Only

  • {{Title}} Remove
  Read more

• PDA Forms New Chapter in Pacific Northwest

  Nov 5, 2018
  Category:
  • People
  • Free

  • {{Title}} Remove
  Read more

• Modular Manufacturing Begins to Take Hold

  Oct 31, 2018
  Category:
  • Science
  • Members Only

  • {{Title}} Remove
  Read more

• West Coast Chapter Hosts Women in Biopharma Panel

  Oct 22, 2018
  Category:
  • People
  • Members Only

  • {{Title}} Remove
  Read more

• Future Challenges in Visual Inspection Processes

  Oct 16, 2018
  Category:
  • Members Only
  • Regulatory

  • {{Title}} Remove
  Read more

• Big Data, Pharma 4.0 and Legacy Products

  Oct 2, 2018
  Category:
  • Science
  • Members Only

  • {{Title}} Remove
  Read more

• Big Data: The Panacea for Pharma’s Ills?

  Oct 1, 2018
  Category:
  • Members Only
  • Science

  • {{Title}} Remove
  Read more

• Build Your CCI Knowledge Base Through Data, Tech

  Oct 1, 2018
  Category:
  • Members Only
  • Science

  • {{Title}} Remove
  Read more

• Meet the PDA Letter’s First Intern

  Oct 1, 2018
  Category:
  • People
  • Members Only

  • {{Title}} Remove
  Read more

• Hot Read: GMP in Practice

  Oct 1, 2018
  Category:
  • Regulatory
  • Free

  • {{Title}} Remove
  Read more

• Exciting New Changes are Coming to Pharma

  Oct 1, 2018
  Category:
  • Members Only
  • Science

  • {{Title}} Remove
  Read more

• Pharmacy Student Sees Future of Pharma in Berlin

  Oct 1, 2018
  Category:
  • People
  • Members Only

  • {{Title}} Remove
  Read more

• Risk-Benefit Analysis More of NCA Scope

  Oct 1, 2018
  Category:
  • Regulatory
  • Members Only

  • {{Title}} Remove
  Read more

• New Perspectives on Freeze-Drying

  Oct 1, 2018
  Category:
  • Science
  • Free

  • {{Title}} Remove
  Read more

• Southeast Chapter Meeting Pairs Wine, Decon Tech

  Oct 1, 2018
  Category:
  • People
  • Members Only

  • {{Title}} Remove
  Read more

• Standing Guard

  Sep 26, 2018
  Category:
  • Free
  • Science

  • {{Title}} Remove
  Read more

• Endotoxin Testing Using Recombinant Reagents

  Sep 18, 2018
  Category:
  • Science
  • Free

  • {{Title}} Remove
  Read more

• A Deep Dive into Pharmacopeial Harmonization

  Sep 11, 2018
  Category:
  • Members Only
  • Regulatory

  • {{Title}} Remove
  Read more

• Deep Learning in the Information Swamp

  Sep 11, 2018
  Category:
  • Science
  • Free

  • {{Title}} Remove
  Read more

• Does QRM + RMM = Better EM?

  Sep 4, 2018
  Category:
  • Free
  • Science

  • {{Title}} Remove
  Read more

• Build Connections at Two PDA Events

  Aug 27, 2018
  Category:
  • People
  • Free

  • {{Title}} Remove
  Read more

• New Trends, New Challenges for BET

  Aug 27, 2018
  Category:
  • Science
  • Members Only

  • {{Title}} Remove
  Read more

• Going Beyond Patient Preference

  Aug 27, 2018
  Category:
  • Science
  • Free

  • {{Title}} Remove
  Read more

• What Annex 1 Means for Sterilization and Moist Steam

  Aug 27, 2018
  Category:
  • Members Only
  • Science

  • {{Title}} Remove
  Read more

• Drug Delivery Combination Products Go “Viral”

  Aug 27, 2018
  Category:
  • Regulatory
  • Free

  • {{Title}} Remove
  Read more

• Draft Annex 1 Separates Cleaning and Disinfection

  Aug 27, 2018
  Category:
  • Science
  • Members Only

  • {{Title}} Remove
  Read more

• Biologics Packaging Presents Risks

  Aug 27, 2018
  Category:
  • Science
  • Members Only

  • {{Title}} Remove
  Read more

• Data Integrity in the Age of Metadata and Big Data

  Aug 27, 2018
  Category:
  • Regulatory
  • Members Only

  • {{Title}} Remove
  Read more

• Revised USP Micro Chapters Address Changing Technologies

  Aug 27, 2018
  Category:
  • Science
  • Members Only

  • {{Title}} Remove
  Read more

• A Wealth of New Micro Regulations

  Aug 27, 2018
  Category:
  • Regulatory
  • Members Only

  • {{Title}} Remove
  Read more

• Strategies to Address E/L Container Closure Challenges

  Aug 23, 2018
  Category:
  • Free
  • Regulatory

  • {{Title}} Remove
  Read more

• Industry Converges on Pharmacopeial Convergence

  Aug 21, 2018
  Category:
  • Regulatory
  • Members Only

  • {{Title}} Remove
  Read more

• India Chapter Goes into the Cold

  Aug 14, 2018
  Category:
  • People
  • Members Only

  • {{Title}} Remove
  Read more

• Visual Inspection Workshop Addresses Annex 1, New Tech

  Aug 7, 2018
  Category:
  • Science
  • Members Only

  • {{Title}} Remove
  Read more

• Russian GMP Inspections Present Challenges, Opportunities: Part II

  Jul 31, 2018
  Category:
  • Regulatory
  • Members Only

  • {{Title}} Remove
  Read more

• Russian GMP Inspections Present Challenges, Opportunities: Part I

  Jul 31, 2018
  Category:
  • Members Only
  • Regulatory

  • {{Title}} Remove
  Read more

• Not So Different After All

  Jul 24, 2018
  Category:
  • People
  • Free

  • {{Title}} Remove
  Read more

• Reclaiming Efficiency Amid Serialization Nightmares

  Jul 24, 2018
  Category:
  • Regulatory
  • Members Only

  • {{Title}} Remove
  Read more

• Evaluating Cell Viability After Cryopreservation

  Jul 17, 2018
  Category:
  • Members Only
  • Science

  • {{Title}} Remove
  Read more

• PDA Participates in Nipro Experience Days

  Jul 17, 2018
  Category:
  • Members Only
  • Science

  • {{Title}} Remove
  Read more

• New Serialization Regs Impact Global Pharma

  Jul 9, 2018
  Category:
  • Regulatory
  • Members Only

  • {{Title}} Remove
  Read more

• 2018 PDA Summer Reading

  Jul 9, 2018
  Category:
  • Science
  • Members Only

  • {{Title}} Remove
  Read more

• A Risk-Based Approach to Supplier Management

  Jul 9, 2018
  Category:
  • Members Only
  • Regulatory

  • {{Title}} Remove
  Read more

• Viscous Product No Match for New CCI Tech

  Jul 9, 2018
  Category:
  • Science
  • Members Only

  • {{Title}} Remove
  Read more

• Blockchain: Will it Transform the Pharmaceutical Supply Chain?

  Jul 9, 2018
  Category:
  • Regulatory
  • Members Only

  • {{Title}} Remove
  Read more

• Are You Ready for the eCTD Mandate?

  Jul 9, 2018
  Category:
  • Regulatory
  • Members Only

  • {{Title}} Remove
  Read more

• A Not-So-Sweet Smell: Part II

  Jul 9, 2018
  Category:
  • Science
  • Members Only

  • {{Title}} Remove
  Read more

• Quality/Compliance Management for Virtual Companies

  Jul 9, 2018
  Category:
  • Regulatory
  • Members Only

  • {{Title}} Remove
  Read more

• Five Critical Endotoxin Testing Concerns

  Jul 9, 2018
  Category:
  • Science
  • Members Only

  • {{Title}} Remove
  Read more

• Opportunities to Build and Grow Your Network

  Jul 9, 2018
  Category:
  • People
  • Free

  • {{Title}} Remove
  Read more

• Visual Inspection Remains Critical

  Jul 9, 2018
  Category:
  • Regulatory
  • Members Only

  • {{Title}} Remove
  Read more

• How to Best Tackle Biosimilar Challenges

  Jul 9, 2018
  Category:
  • Science
  • Free

  • {{Title}} Remove
  Read more

• 3 Questions for Biogen’s Amy Wilson

  Jun 25, 2018
  Category:
  • Science
  • Members Only

  • {{Title}} Remove
  Read more

• Pharma Must Work “Smarter” in New Era

  Jun 19, 2018
  Category:
  • Science
  • Members Only

  • {{Title}} Remove
  Read more

• Chapter Grows Professional Opportunities Across Industry

  Jun 5, 2018
  Category:
  • People
  • Members Only

  • {{Title}} Remove
  Read more

• Prospects for Post-Approval Change Management

  May 29, 2018
  Category:
  • Regulatory
  • Members Only

  • {{Title}} Remove
  Read more

• Eyeing the Future of Biomanufacturing

  May 29, 2018
  Category:
  • People
  • Members Only

  • {{Title}} Remove
  Read more

• A Not-So-Sweet Smell: Part I

  May 29, 2018
  Category:
  • Members Only
  • Science

  • {{Title}} Remove
  Read more

• Can ICH Q12 Unlock Manufacturing Innovation?

  May 29, 2018
  Category:
  • Regulatory
  • Members Only

  • {{Title}} Remove
  Read more

• Growing Acceptance of Real-Time Monitoring

  May 29, 2018
  Category:
  • Members Only
  • Regulatory

  • {{Title}} Remove
  Read more

• Seeing the Light

  May 29, 2018
  Category:
  • Members Only
  • Regulatory

  • {{Title}} Remove
  Read more

• Getting Biosimilars Right the First Time

  May 29, 2018
  Category:
  • Free
  • Science

  • {{Title}} Remove
  Read more

• Knowledge Grows for mAb Development

  May 29, 2018
  Category:
  • Free
  • Science

  • {{Title}} Remove
  Read more

• A Wealth of New Tech Possibilities

  May 16, 2018
  Category:
  • Members Only
  • Science

  • {{Title}} Remove
  Read more

• A Tale of Two Vials

  May 7, 2018
  Category:
  • Science
  • Members Only

  • {{Title}} Remove
  Read more

• 3-D Printing and Biopharmaceutical Manufacturing

  Apr 30, 2018
  Category:
  • Science
  • Members Only

  • {{Title}} Remove
  Read more

• Strategies for Reducing Data Integrity Challenges

  Apr 30, 2018
  Category:
  • Regulatory
  • Members Only

  • {{Title}} Remove
  Read more

• PDA Responds to Annex 1 Revision

  Apr 30, 2018
  Category:
  • Free
  • Regulatory

  • {{Title}} Remove
  Read more

• Container Closure Integrity Requires Adaptation

  Apr 30, 2018
  Category:
  • Regulatory
  • Members Only

  • {{Title}} Remove
  Read more

• RMAT Program Raises a Few Questions

  Apr 30, 2018
  Category:
  • Science
  • Members Only

  • {{Title}} Remove
  Read more

• Make New Buddies in Berlin

  Apr 30, 2018
  Category:
  • People
  • Free

  • {{Title}} Remove
  Read more

• Running the Numbers for Analytical Similarity

  Apr 30, 2018
  Category:
  • Members Only
  • Regulatory

  • {{Title}} Remove
  Read more

• Amgen Team Brings Expertise to Taiwan Chapter

  Apr 30, 2018
  Category:
  • People
  • Members Only

  • {{Title}} Remove
  Read more

• Glass Versus Cyclic Olefin Polymers

  Apr 25, 2018
  Category:
  • Science
  • Members Only

  • {{Title}} Remove
  Read more

• New Drugs Need Agile Biomanufacturing

  Apr 17, 2018
  Category:
  • Members Only
  • Science

  • {{Title}} Remove
  Read more

• Speaking the Language of GMP

  Apr 3, 2018
  Category:
  • Science
  • Members Only

  • {{Title}} Remove
  Read more

• Packaging Critical to Success of Drug Products

  Apr 2, 2018
  Category:
  • Members Only
  • Regulatory

  • {{Title}} Remove
  Read more

• Know Your Numbers for Analytical Similarity

  Apr 2, 2018
  Category:
  • Members Only
  • Science

  • {{Title}} Remove
  Read more

• PDA Celebrates Ten Years of ATMP Conferences

  Apr 2, 2018
  Category:
  • People
  • Free

  • {{Title}} Remove
  Read more

• ATMPs: What a Difference a Year Can Make

  Apr 2, 2018
  Category:
  • Free
  • Regulatory

  • {{Title}} Remove
  Read more

• Moving the Patient to the Forefront

  Apr 2, 2018
  Category:
  • Members Only
  • Science

  • {{Title}} Remove
  Read more

• Cell and Gene Therapies Present Challenges, Promise

  Apr 2, 2018
  Category:
  • Science
  • Members Only

  • {{Title}} Remove
  Read more

• Volunteering Opens Doors for Student Chapter

  Apr 2, 2018
  Category:
  • People
  • Members Only

  • {{Title}} Remove
  Read more

• Sterilizing Grade Filters and PUPSIT

  Mar 28, 2018
  Category:
  • Members Only
  • Science

  • {{Title}} Remove
  Read more

• Novel Manufacturing Tech Drives Novel Product Development

  Mar 20, 2018
  Category:
  • Science
  • Members Only

  • {{Title}} Remove
  Read more

• Glass Along the Value Chain

  Mar 13, 2018
  Category:
  • Science
  • Members Only

  • {{Title}} Remove
  Read more

• Awareness Critical for Container Closure Components

  Mar 6, 2018
  Category:
  • Regulatory

  • {{Title}} Remove
  Read more

• Honoring PDA’s Female Volunteer Leaders

  Feb 26, 2018
  Category:
  • Free
  • People

  • {{Title}} Remove
  Read more

• Smoke Signals

  Feb 26, 2018
  Category:
  • Science
  • Members Only

  • {{Title}} Remove
  Read more

• New Approach Suggests Continuous Lyophilization is Possible

  Feb 26, 2018
  Category:
  • Science
  • Members Only

  • {{Title}} Remove
  Read more

• PDA Staff Try a Hand at Aseptic Processing

  Feb 26, 2018
  Category:
  • People
  • Members Only

  • {{Title}} Remove
  Read more

• Seeing the Hidden

  Feb 26, 2018
  Category:
  • Science
  • Members Only

  • {{Title}} Remove
  Read more

• Korea Chapter Inaugurates New KPDA Hall

  Feb 26, 2018
  Category:
  • People
  • Members Only

  • {{Title}} Remove
  Read more

• H20 Requirements for Superheated Sterilization

  Feb 26, 2018
  Category:
  • Members Only
  • Science

  • {{Title}} Remove
  Read more

• Changes to USP Council of Experts

  Feb 26, 2018
  Category:
  • Regulatory
  • Members Only

  • {{Title}} Remove
  Read more

• New Tech Disrupts Traditional Aseptic Processing

  Feb 20, 2018
  Category:
  • Science
  • Free

  • {{Title}} Remove
  Read more

• Adapt Your Nest-and-Tub System as the Industry Evolves

  Feb 13, 2018
  Category:
  • Science
  • Members Only

  • {{Title}} Remove
  Read more

• New Trends Require Investment from Vaccine Makers

  Feb 6, 2018
  Category:
  • Science
  • Free

  • {{Title}} Remove
  Read more

• High Regulatory Expectations for Biosimilars

  Jan 30, 2018
  Category:
  • Regulatory
  • Members Only

  • {{Title}} Remove
  Read more

• More Opportunities to Grow Your Network

  Jan 29, 2018
  Category:
  • People
  • Free

  • {{Title}} Remove
  Read more

• Teamwork Crucial to SUS Sterilization Validation

  Jan 29, 2018
  Category:
  • Science
  • Members Only

  • {{Title}} Remove
  Read more

• Formalizing a Risk Assessment for Excipients

  Jan 29, 2018
  Category:
  • Regulatory
  • Free

  • {{Title}} Remove
  Read more

• PDA Prefilled Syringes Exhibition Draws Crowd

  Jan 29, 2018
  Category:
  • People
  • Members Only

  • {{Title}} Remove
  Read more

• Extractables Testing of Aluminosilicate and Borosilicate Glass Containers

  Jan 29, 2018
  Category:
  • Science
  • Members Only

  • {{Title}} Remove
  Read more

• Student Chapter Shows Enthusiasm for Industry

  Jan 29, 2018
  Category:
  • People
  • Members Only

  • {{Title}} Remove
  Read more

• 4 Capabilities to Operationalizing Resilience

  Jan 29, 2018
  Category:
  • Science
  • Members Only

  • {{Title}} Remove
  Read more

• Achieve True Manufacturing Reliability

  Jan 23, 2018
  Category:
  • Science
  • Free

  • {{Title}} Remove
  Read more

• Chapter Learns About Future of Facility Design

  Jan 16, 2018
  Category:
  • People
  • Members Only

  • {{Title}} Remove
  Read more

• Quality and Innovation are Not Incompatible

  Jan 9, 2018
  Category:
  • Members Only
  • Regulatory

  • {{Title}} Remove
  Read more

• Quality: One Question, Many Answers

  Jan 9, 2018
  Category:
  • Regulatory
  • Members Only

  • {{Title}} Remove
  Read more

• Collaboration Through Mutual Reliance Brings FDA and EMA to the Table

  Jan 2, 2018
  Category:
  • Regulatory
  • Members Only

  • {{Title}} Remove
  Read more

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

  Jan 2, 2018
  Category:
  • Members Only
  • Science

  • {{Title}} Remove
  Read more

• Disruptive Change is on the Horizon

  Jan 2, 2018
  Category:
  • Science
  • Free

  • {{Title}} Remove
  Read more

• Flexibility Needed for PAC

  Jan 2, 2018
  Category:
  • Regulatory
  • Free

  • {{Title}} Remove
  Read more

• Regulators Tackle Tough Micro Questions on Panel

  Jan 2, 2018
  Category:
  • Science
  • Members Only

  • {{Title}} Remove
  Read more

• New PDA Task Force Targets Big Data

  Dec 13, 2017
  Category:
  • Science
  • Free

  • {{Title}} Remove
  Read more

• Brazil Chapter Offers Hands-On Aseptic Training

  Dec 5, 2017
  Category:
  • People
  • Members Only

  • {{Title}} Remove
  Read more

• Cracking the Challenges of Glass Packaging

  Nov 28, 2017
  Category:
  • Free
  • Regulatory

  • {{Title}} Remove
  Read more

• Millennials: How Manufacturers are Training the Next Generation

  Nov 6, 2017
  Category:
  • People
  • Members Only

  • {{Title}} Remove
  Read more

• Record Scholarships Awarded at NE Chapter Dinner

  Nov 6, 2017
  Category:
  • Members Only
  • People

  • {{Title}} Remove
  Read more

• CFDA Encouraged to Review PDA Docs

  Nov 6, 2017
  Category:
  • Members Only
  • Regulatory

  • {{Title}} Remove
  Read more

• PDA Staff Gown Up for Site Visit at Pilot Plant

  Nov 6, 2017
  Category:
  • Science
  • Members Only

  • {{Title}} Remove
  Read more

• PDA on the Move

  Nov 6, 2017
  Category:
  • Members Only
  • People

  • {{Title}} Remove
  Read more

• Worst-Case Analysis of Cell Growth in SUS

  Nov 6, 2017
  Category:
  • Science
  • Members Only

  • {{Title}} Remove
  Read more

• Networking Lights Up PDA/FDA JRC Exhibit Hall

  Nov 6, 2017
  Category:
  • People
  • Members Only

  • {{Title}} Remove
  Read more

• Isolator Surfaces and Contamination Risks to Personnel

  Nov 6, 2017
  Category:
  • Members Only
  • Science

  • {{Title}} Remove
  Read more

• AIDC is a Sign of Things to Come: Part II

  Oct 31, 2017
  Category:
  • Regulatory
  • Members Only

  • {{Title}} Remove
  Read more

• AIDC is a Sign of Things to Come: Part I

  Oct 31, 2017
  Category:
  • Regulatory
  • Members Only

  • {{Title}} Remove
  Read more

• A Risk Assessment is an Opportunity Assessment

  Oct 18, 2017
  Category:
  • Regulatory
  • Members Only

  • {{Title}} Remove
  Read more

• PDA and IFPMA Foster Discussion on PAC

  Oct 10, 2017
  Category:
  • Free
  • Regulatory

  • {{Title}} Remove
  Read more

• Prefilled Syringe Manufacturing Moves Away from Hands-On Approach

  Oct 3, 2017
  Category:
  • Science
  • Members Only

  • {{Title}} Remove
  Read more

• Two Views on Packaging from Prefilled Exhibitors

  Oct 3, 2017
  Category:
  • Science
  • Members Only

  • {{Title}} Remove
  Read more

• Five Keys to Manufacturing Success

  Oct 3, 2017
  Category:
  • Regulatory
  • Members Only

  • {{Title}} Remove
  Read more

• One Company’s Approach to Rapid Micro Methods

  Oct 3, 2017
  Category:
  • Science
  • Members Only

  • {{Title}} Remove
  Read more

• Ireland Chapter Provides Once in a Lifetime Trip

  Oct 3, 2017
  Category:
  • People
  • Members Only

  • {{Title}} Remove
  Read more

• New Realities for Prefilled Syringes

  Sep 27, 2017
  Category:
  • Regulatory
  • Free

  • {{Title}} Remove
  Read more

• Industry Awaits Annex 1 Revision

  Sep 19, 2017
  Category:
  • Regulatory
  • Members Only

  • {{Title}} Remove
  Read more

• The QC Lab of the Future

  Sep 13, 2017
  Category:
  • Science
  • Members Only

  • {{Title}} Remove
  Read more

• Novel Drug Products Drive New Views on Suitability

  Aug 29, 2017
  Category:
  • Regulatory
  • Free

  • {{Title}} Remove
  Read more

• Visual Inspection Faces Changing Environment

  Aug 29, 2017
  Category:
  • Regulatory
  • Free

  • {{Title}} Remove
  Read more

• One Simple Way to Manage Aseptic Risk Assessments

  Aug 29, 2017
  Category:
  • Science
  • Members Only

  • {{Title}} Remove
  Read more

• Company Sees Success With Automated Endotoxin Testing

  Aug 29, 2017
  Category:
  • Science
  • Members Only

  • {{Title}} Remove
  Read more

• Four Steps to Ensuring Data Integrity for BET

  Aug 29, 2017
  Category:
  • Regulatory
  • Members Only

  • {{Title}} Remove
  Read more

• Why the Surface is Critical to Disinfection Testing

  Aug 29, 2017
  Category:
  • Science
  • Members Only

  • {{Title}} Remove
  Read more

• PQS: An Effective Lever for Managing PACs

  Aug 22, 2017
  Category:
  • Regulatory
  • Free

  • {{Title}} Remove
  Read more

• The Future of Cell and Gene Therapies is Here

  Aug 15, 2017
  Category:
  • Science
  • Free

  • {{Title}} Remove
  Read more

• The Cost of Microbial Control

  Aug 8, 2017
  Category:
  • Free
  • Science

  • {{Title}} Remove
  Read more

• A Stepwise Approach to Effective Data Management and Analysis

  Jul 25, 2017
  Category:
  • Free
  • Science

  • {{Title}} Remove
  Read more

• Women in Biotech Panel Offers Career Advice for All Sexes

  Jul 18, 2017
  Category:
  • Free
  • People

  • {{Title}} Remove
  Read more

• India Chapter Holds Successful Biologics Workshop

  Jul 10, 2017
  Category:
  • People
  • Members Only

  • {{Title}} Remove
  Read more

• Difficult-to-Inspect Drugs Require New Processes

  Jul 10, 2017
  Category:
  • Regulatory
  • Free

  • {{Title}} Remove
  Read more

• When Microbiologists Collaborate, Great Things Happen

  Jul 10, 2017
  Category:
  • Science
  • Free

  • {{Title}} Remove
  Read more

• Can Single-Use Components Be Commodities?

  Jul 10, 2017
  Category:
  • Science
  • Members Only

  • {{Title}} Remove
  Read more

• Regulatory Submissions: No Longer Paper-Based

  Jul 10, 2017
  Category:
  • Regulatory
  • Members Only

  • {{Title}} Remove
  Read more

• Build Your Network at the PDA/FDA JRC

  Jul 10, 2017
  Category:
  • People
  • Free

  • {{Title}} Remove
  Read more

• OPQ Establishes Manufacturing Science CoE

  Jul 10, 2017
  Category:
  • Regulatory
  • Free

  • {{Title}} Remove
  Read more

• PDA Summer Reading for 2017

  Jul 10, 2017
  Category:
  • Science
  • Members Only

  • {{Title}} Remove
  Read more

• A Maturing Model of Quality

  Jul 10, 2017
  Category:
  • Regulatory
  • Free

  • {{Title}} Remove
  Read more

• Industry Expert Weighs in on Quality Metrics

  Jul 10, 2017
  Category:
  • Regulatory
  • Free

  • {{Title}} Remove
  Read more

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

  Jul 10, 2017
  Category:
  • Members Only
  • Regulatory

  • {{Title}} Remove
  Read more

• PDA’s 4th Metrics Conference

  Jul 10, 2017
  Category:
  • Members Only
  • Regulatory

  • {{Title}} Remove
  Read more

• PQRI Establishes Thresholds for L&E Identification

  Jun 27, 2017
  Category:
  • Members Only
  • Science

  • {{Title}} Remove
  Read more

• Knowledge is Power

  Jun 13, 2017
  Category:
  • Regulatory
  • Free

  • {{Title}} Remove
  Read more

• Perspectives on Packaging

  Jun 8, 2017
  Category:
  • Science
  • Free

  • {{Title}} Remove
  Read more

• Industry Experts: Quality Requires Proactive Approach

  May 30, 2017
  Category:
  • Regulatory
  • Free

  • {{Title}} Remove
  Read more

• The Future of Glass in Parenteral Packaging

  May 30, 2017
  Category:
  • Members Only
  • Science

  • {{Title}} Remove
  Read more

• New Guidance for Visual Inspection Available

  May 30, 2017
  Category:
  • Free
  • Regulatory

  • {{Title}} Remove
  Read more

• Gowning Requirement for Blow-Fill-Seal Technology

  May 30, 2017
  Category:
  • Science
  • Members Only

  • {{Title}} Remove
  Read more

• MAbs Require Ongoing Dialogue

  May 30, 2017
  Category:
  • Regulatory
  • Free

  • {{Title}} Remove
  Read more

• Prefilled Syringes Bring Patient to the Forefront

  May 30, 2017
  Category:
  • Science
  • Free

  • {{Title}} Remove
  Read more

• Microbiologists Put Under the Microscope

  May 30, 2017
  Category:
  • People
  • Members Only

  • {{Title}} Remove
  Read more

• How to Use QbD to Select Packaging Components

  May 30, 2017
  Category:
  • Regulatory
  • Members Only

  • {{Title}} Remove
  Read more

• Putting the Pieces Together

  May 30, 2017
  Category:
  • Members Only
  • Science

  • {{Title}} Remove
  Read more

• Creating a Global Incentive for Pharma

  May 23, 2017
  Category:
  • Regulatory
  • Free

  • {{Title}} Remove
  Read more

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

  May 2, 2017
  Category:
  • Members Only
  • Science

  • {{Title}} Remove
  Read more

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

  May 2, 2017
  Category:
  • Free
  • Regulatory

  • {{Title}} Remove
  Read more

• Pharma Has its Head in the Cloud

  May 1, 2017
  Category:
  • Science
  • Members Only

  • {{Title}} Remove
  Read more

• Cost of Quality Still a Factor

  May 1, 2017
  Category:
  • Regulatory
  • Members Only

  • {{Title}} Remove
  Read more

• Buddy Up in Berlin with New PDA Pals

  May 1, 2017
  Category:
  • Free
  • People

  • {{Title}} Remove
  Read more

• Regulators, USP Taking a Close Look at Visual Inspection

  May 1, 2017
  Category:
  • Regulatory
  • Free

  • {{Title}} Remove
  Read more

• A Case Study in Aseptic Gas Plasma Decontamination

  May 1, 2017
  Category:
  • Science
  • Members Only

  • {{Title}} Remove
  Read more

• Japan Chapter Marks 25 Years at Annual Event

  May 1, 2017
  Category:
  • People
  • Members Only

  • {{Title}} Remove
  Read more

• Human Element Key to Digital Transformation

  Apr 25, 2017
  Category:
  • Science
  • Free

  • {{Title}} Remove
  Read more

• A QUICK Guide To Selecting a CMO

  Apr 18, 2017
  Category:
  • Regulatory
  • Members Only

  • {{Title}} Remove
  Read more

• IG Meetings to Address Complexity of New Products

  Apr 4, 2017
  Category:
  • Regulatory
  • Free

  • {{Title}} Remove
  Read more

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

  Apr 4, 2017
  Category:
  • Science
  • Members Only

  • {{Title}} Remove
  Read more

• Viral Safety Approaches for Advanced Therapy Medicinal Products

  Apr 4, 2017
  Category:
  • Science
  • Free

  • {{Title}} Remove
  Read more

• WHO Should Align with ICH on PACs

  Apr 4, 2017
  Category:
  • Free
  • Regulatory

  • {{Title}} Remove
  Read more

• Quality Metrics to Impact Different Pharma Sectors

  Mar 14, 2017
  Category:
  • Regulatory
  • Free

  • {{Title}} Remove
  Read more

• Leveraging Video to Improve Operations

  Mar 7, 2017
  Category:
  • People
  • Free

  • {{Title}} Remove
  Read more

• Storm Surrounds Clinical Trial Data in China

  Feb 7, 2017
  Category:
  • Regulatory
  • Free

  • {{Title}} Remove
  Read more

• Annex 1 Showcases the Need for Clear Guidance

  Jan 10, 2017
  Category:
  • Free
  • Regulatory

  • {{Title}} Remove
  Read more

• GMP Oversight of Medicines Manufacturers in the European Union

  Nov 14, 2016
  Category:
  • Free
  • Regulatory

  • {{Title}} Remove
  Read more

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

  Oct 4, 2016
  Category:
  • People
  • Members Only

  • {{Title}} Remove
  Read more

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

  Sep 27, 2016
  Category:
  • Free
  • Science

  • {{Title}} Remove
  Read more

• PDA Program to Address Post-Approval Hurdles

  Aug 24, 2016
  Category:
  • Free
  • Regulatory

  • {{Title}} Remove
  Read more

• When Data Integrity Takes Front and Center Stage

  Aug 9, 2016
  Category:
  • Members Only
  • Regulatory

  • {{Title}} Remove
  Read more

• Three Questions for MHRA’s David Churchward

  Jul 26, 2016
  Category:
  • Regulatory
  • Members Only

  • {{Title}} Remove
  Read more

• Four Steps to Conducting a Successful Data Integrity Audit

  Jul 19, 2016
  Category:
  • Regulatory
  • Free

  • {{Title}} Remove
  Read more

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

  Jul 7, 2016
  Category:
  • Free
  • Science

  • {{Title}} Remove
  Read more

• Data Integrity and the Preapproval Inspection

  Jun 22, 2016
  Category:
  • Regulatory
  • Members Only

  • {{Title}} Remove
  Read more

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

  May 31, 2016
  Category:
  • Science
  • Free

  • {{Title}} Remove
  Read more

• Drug Shortage is a "Wicked Problem"

  May 4, 2016
  Category:
  • Free
  • Regulatory

  • {{Title}} Remove
  Read more

Awareness Critical for Container Closure Components

Subscribe to RSS

 

 

Join PDA’s community of experts

Authors wanted for the PDA Letter and the PDA Journal of Pharmaceutical Science and Technology.

On the Issue Videos

Interviews with leading industry experts on the issues important to you.