Good Manufacturing Practices (GMP) In Pharmaceutical Production

Course Objectives

Upon completion of this program, participants should be able to:

• Understand their personal role in the GMP quality system.
• Develop background as to why the regulation must be followed each and every day.
• Equip with tools to help enhance the already existing GMP system at their facilities.

Target Audience

This course is suitable for Executives, Supervisors, Team Leaders, Managers and those who are or will be entering a GMP environment; for employees that have been given new responsibilities within a GMP regulated industry and for people who are responsible for supervising or managing the GMP quality system

Methodology

This program will be conducted with interactive lectures, PowerPoint presentation, discussions and practical exercise

Course Modules

• Module 1 : Infrastructure – Facilities, Utilities And Equipment
• Module 2 – Process & Manufacturing Control
• Module 3 – Cleaning, Sanitization And Sterilization Systems
• Module 4 : Safety Of The Products In Supply Chain
• Module 5 : Business Continuity And Disaster Recovery Planning
• Module 6 : Audits And Self-Inspections
• Module 7 : Documents And Records Management
• Module 8 : Product Quality Complaints Vs. Adverse Event Reports
• Module 9 : Training And Personnel Qualification