Double Dragon is assessing interest for 2017 DI Auditing Workshops

Proposed topics:
  • How to conduct a Data Integrity Audit of a QC lab using FDA inspection techniques – 2 days
  • Auditing for Data Integrity issues in Manufacturing – 1 day

March 2017 – East Coast / West Coast Locations TBD

Final dates and locations will be determined based on your comments. For more information, please submit your information below.

    QC Lab Auditing Course outline:
    • Introduction and Background
    • General Data Integrity (DI) Audit Techniques
    • Audit Techniques – Computerized Systems and Audit Trails
      • HPLC
      • GC
      • FTIR
    • Audit Techniques – Chemistry
    • Remediation – What to do with Confirmed DI Issues?

    Manufacturing Auditing Course outline:
    • Introduction and Background
    • General Data Integrity (DI) Audit Techniques
    • Audit Techniques
      • Process Control Systems
      • Maintenance Management Systems
      • In-process testing
      • Batch Records
    • Remediation – What to do with Confirmed DI Issues?

     

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