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.

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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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