CERTIFICATE TRAINING

PHARMACEUTICAL AUDIT & INSPECTION

Program Overview:

Auditing and Inspection is a critical function within a pharmaceutical company. It provides quality management tool with information about how effectively the organization controls the quality of their processes, system and products. Auditors must perform their jobs competently to ensure their company’s compliance with pharmaceutical GMP regulations and other quality standards like ICH Q10.  This online webinar includes full range of audit preparation module that provides guidance in preparing for regulatory GMP inspections and is designed to provide broad fundamental industry knowledge for individuals that want to expand their GMP knowledge.

Program Modules:

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 involve 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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Location:


  • Beginners level auditors or individuals wanting to become auditors.
  • Individuals with few years of experience working with the GMP/ICH guidelines who want to develop additional expertise in GMP Auditing.
  • Internal auditors/audit teams
  • Suppliers and companies who are audited

Testimonials

  • Robert Bess, B.Sc.

    Production Technician, Apotex Inc.

    NACPT helped me enormously and I shall be eternally grateful.

  • Dr.Taiwo Sonoiki

    Clinical Assistant

    For new immigrants like myself, the difficulty in obtaining Canadian references proves to be an important challenge.

  • Lorrein Muiruri, BSc., from UofT

    Clinical research Assistant, Inflamax Research Inc

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