The various regulatory agencies have expectations that pharmaceutical manufacturers will demonstrate control over their manufacturing equipment. The FDA's findings of deficiencies concerning equipment validation indicate the agencies expect definitive evidence that the equipment qualification and validation schedules of a facility will satisfactorily control their manufacturing processes. Examples of FDA form 483 findings for equipment qualification and validation indicate deficiencies in many of these studies.
Upon completing this course participants should:
Understand what the global expectations are for equipment qualification and validation.
Understand the documents required for equipment qualification and process validation and how to manage documents appropriately.
Understand and know how to write and maintain a Validation Master Plan.
Write and execute sound protocols for equipment qualification (IQ, OQ, PQ) and process validation.
Qualify already existing systems and requalification
Be able to collect data, conduct tests, and obtain all necessary documents.
Understand the different types of validation.
Who Will Benefit:
This course is designed for people tasked with developing, maintaining and/or improving equipment qualification programs for manufacturing facilities. This includes individuals that have Quality Management Systems responsibilities for making general improvements in their organization's performance specifically related to equipment and processes. Following personnel will benefit from the course:
Senior quality managers
Use coupon code NB5SQH8N and get 10% off on registration.