Program in Quality Assurance Management and Good Manufacturing Practice (ICH-GMP).
Program Outline:
1- Introduction to Quality Management Systems and Quality Assurance and Good Manufacturing Practices (ICH-GMP)
2- Essential Elements of GMP & Technical and Regulatory documents for QA: (SOP, OOS, Deviation and Validation Reports, Change Control, and Product Quality Review)
3- Audit and Inspection management
4- Handling Product Complaints and Recalls
Learn how to write SOPs (Standard Operating Procedures) and about various other technical documents.
Learn about GMP validation requirements for QA
Learn about the Guidance on writing a product Quality Review for QA