ISPE Online Live Training Courses

Through lecture and group exercises this course illustrates how quality systems work, the purpose of the different elements, how they connect to each other and how to recognize and transfer knowledge/connectivity throughout the organization. The diagram below from ICH Q10, covers the product life cycle for a PQS/QMS system and all aspects will be covered by this course.

This training course on Pharmaceutical Technology Transfer identifies criteria for successful technology transfer and provides ‘how to’ examples which can be individually tailored, depending on the type and scope of transfer.

This training course focuses on common issues and problems in the operation of a facility and maintaining readiness for cGMP inspection. Topics include control system alarm management, common system construction deficiencies, cGMP documentation, maintaining an "inspection ready" state, frequency of testing and balancing, airflow visualization, air change rate reduction and more.

This course covers the risk-based approach to cleaning development and verification; risk analysis; procedures and evaluation tools including  FMEA / FMECA, master planning, risk control, PAT, periodic assessment and monitoring, risk review and communication.