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PDA Members Recommend ICH Q9 Changes

  • Quality & Regulatory

Task Group Formed to Craft PDA Quality Culture Standard

  • Quality & Regulatory

Guest Editorial: We Should Expect Drug Shortages to Get Worse

  • Supply Chain & Outsourcing

Real-World Applications of Rapid Micro Methods

  • Aseptic Processing & Sterilization

Cryogenic Storage Challenges for Container-Closure Systems

  • Biopharmaceuticals & Biotechnology

Sterility Test Failure Investigations

  • Aseptic Processing & Sterilization

Qualification of Manual Visual Inspection Still Critical

  • Manufacturing Science

The Product Quality Leader Team Part II: Getting Ahead

  • Biopharmaceuticals & Biotechnology

Moving Beyond “Grande-Sized” Manufacturing for Gene Therapies

  • Biopharmaceuticals & Biotechnology

Tools to Address Human Error Reduction

  • People

40 Years of Visual Inspection: Where Do We Go from Here?

  • Manufacturing Science

Inaugural BioManufacturing Conference Tackles Five Key Issues: Part II

  • Biopharmaceuticals & Biotechnology

Data Integrity: From the Basics to Big Data

  • Quality & Regulatory

Innovations in Aseptic Processing

  • Aseptic Processing & Sterilization

Inaugural BioManufacturing Conference Tackles Five Key Issues: Part I

  • Biopharmaceuticals & Biotechnology

New Decade, New Focus for PDA Letter

  • People
  • Aseptic Processing & Sterilization

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