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Certificate

Pharmaceutical Quality management system

Program code:

Credential:

Certificate

Duration:

Delivery Mode:

Start Date(s):

January | May | September
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Program Overview – Pharmaceutical Quality Management System (QMS)

Quality management systems are essential in the pharmaceutical industry to enhance product quality and reduce the risk of recalls. The Pharmaceutical Quality Management System (QMS), guided by ICH Q10, forms the foundation for quality production and reliable data generation. Gaining knowledge of QMS equips students to excel in quality and management roles within the pharma sector.

After successful completion of this course, students will be:

  • Able to identify and develop quality management systems
  • Able to implement quality management systems
  • Able to improve processes and systems
  • Able to remove defects in process and systems
  • Able to investigate deviations
  • Able to work with inspectors
  • Able to prepare for inspections
  • Able to respond to inspection comments
  • Able to perform an effective gap analysis
  • Able to perform self-inspections

  • 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

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

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

  • QMS Process
  • QMS implementation
  • QMS Process Map

  • QMS tools
  • Risk management
  • Case Study

 

Who Should Attend

Anyone who wants to become the following should attend this pharmaceutical quality management systems training webinar:

  • Beginner level of technical writers or individuals wanting to become technical writers
  • Technical team members
  • Management team members
  • Auditors
  • Consultants
  • Coordinators
  • Auditors
  • Supervisors
  • Managers