About the course:

The course is designed to detail a step-by-step outline for writing, maintaining and updating “Standard Operating Procedures” (SOPs) and Batch Documentation. SOPs and Batch documentation’s role is crucial in maintaining stable and traceable production and is of GMP requirements. During the course trainers will provide SOPs and Batch documentation templates and help your factory specialists to prepare factory specific documents as well as guide on these documents further management and use.

Who should attend:

The course is designed for pharmaceutical production, quality control and assurance personnel.
Certificates of completion are given to course participants upon successful graduation.

Course program:

The course consists from following parts:

  • Definition of batch and role of batch documentation,
  • Traceability issues,
  • SOP and Batch Documentation writing requirements,
  • Purpose and structure of Standard Operation Procedures,
  • Purpose and structure of Batch Documentation,
  • Documentation life cycle,
  • Annual documentation review.

Course Manual:

The course comes with a comprehensive manual, which proves to be an excellent handout and source of reference after the course.