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Certificate

Pharmaceutical Audit & Inspection

Program code:

Credential:

Certificate

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GMP pharma audit/inspection is a critical function within a pharmaceutical company. It provides a quality management tool with information about how effectively the organization controls the quality of their processes, systems, and products, as well as the types of audits in the pharmaceutical industry.This training program includes a full range of audit preparation modules that provide guidance in preparing for regulatory GMP inspections and is designed to deliver broad fundamental industry knowledge for individuals seeking to expand their GMP expertise.

After successful completion of this course, students will be:

  • Able to perform internal audit and inspections
  • Able to conduct vendor or supplier audit
  • Able to investigate deviations
  • Able to produce audit reports
  • CAPA and change control review, tracking and implementation
  • Able to work with inspectors
  • Able to prepare for inspection
  • Able to respond to inspection comments
  • Able to perform an effective gap analysis
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  • Module 1: Introduction to Audit
    • Define an audit and explain why audits are carried out
    • Learn types and levels of audits
    • How to prepare for an audit
  • Module 2: Auditors
    • Explore auditors and skills
    • How to ask questions
    • Describe good listening skills
    • Review the importance of body language on the audit process
  • Module 3: Steps Involved in 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: Often Forgot Points
    • Gain awareness of points that may be missed during an inspection
  • Module 7: Preparing for Regulatory GMP Inspections
    • Preparing to host a regulatory GMP inspection
    • Preparing for activities during the inspection
    • Preparing for activities after the inspection
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Who Should Attend

Anyone who wants to become the following should attend the webinar on Pharmaceutical Auditor Training:
  • Beginner-level auditors or individuals wanting to become auditors
  • Individuals with a few years of experience working with the GMP/ICH guidelines who want to develop additional expertise in GMP auditing
  • Internal auditors or audit teams
  • Suppliers and companies who are audited
  • Auditors
  • Change Control Coordinators
  • QA Associates
  • QA Managers