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An IS0 9001:2015 Certified Institute

GMP Auditing for the Pharmaceutical Industry

Auditing is a critical function within a pharmaceutical company. It provides management with information about how effectively the company controls the quality of their processes and products. Auditors must perform their jobs competently to ensure their company’s compliance with pharmaceutical USFDA GMP regulations and other quality standards like ICH Q10. Auditing for GMP is specifically designed to address the challenges of GMP auditing for the pharmaceutical industry and present the basic competencies required to effectively perform the auditor's assigned responsibilities and contribute to the improvement of auditor performance within a regulated industry. This online course includes a supplemental module that provides guidance in preparing for regulatory GMP inspections and is designed to provide broad fundamental industry knowledge through a customized learning experience for individuals that want to expand their cGMP knowledge.

  • Module 1: Introduction to auditing and Audit preparation
    • Define an audit and explain why audits are carried out
    • Discuss types and levels of audits
    • Discuss preparation for an audit
  • Module 2: Attributes and experiences of a good auditor
    • Explore auditor traits and skills
    • Describe strategies for asking questions
    • Describe good listening skills
    • Review the importance of body language on the audit process
  • Module 3: Steps and activities for successful audits
    • Review the Audit Timetable
    • Provide guidelines for Conducting the Audit
    • Discuss the importance of records and note taking
    • Provide auditing tips and resources for auditors
  • Module 4: Post-audit activities and follow-up
    • Provide guidance for Exit Meeting preparation
    • Explore managing your findings
    • Explore attributes and considerations of a good report
    • Review follow-up activities and problem solving tools
  • Module 5: Inspection points to consider during an audit
    • Review inspection points to consider in auditing
  • Module 6: Interesting points often missed
    • Gain awareness of points that may be missed during an inspection
  • Module 7 (Supplemental): Preparing for Regulatory GMP Inspections
    • Preparing to host a regulatory GMP inspection
    • Preparing for activities during the inspection
    • Preparing for activities after the inspection