Program Overview:

Quality management system in pharmaceuticals supports to improve the product quality and minimize the risk of product recall. The Pharmaceutical Quality Management System (QMS) supported by ICH Q10, is the key foundation of quality production or data generation. Learning the appropriate QMS will help anyone to outperform in the quality and management roles.

Program Modules:

Module 1

  • Different types of quality management systems
    • Document control
    • Change control
    • Enterprise & operational risk management
    • Supplier management
    • Equipment and asset management
    • CAPA management
    • Policy management
    • Internal audit

Module 2

  • Principles of Quality management
  • Quality Systems
  • Elements affect pharmaceutical quality

Module 3

  • ISO Standards
  • Customer Focus
  • Leadership Approach
  • Engagement of Members
  • Process Approach
  • Process/System Improvements
  • Evidence-based Decision Making
  • Relationship Management

Module 4:

  • QMS Process
  • QMS implementation
  • QMS Process Map

Module 5:

  • QMS tools
  • Risk managements
  • Case Study

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  • Beginners level of technical writers or individuals wanting to become technical writers
  • Technical team members
  • Management teams
  • Auditors
  • Consultants


  • 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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