2-Day Virtual Seminar Global Regulations for Equipment Qualification and Validation of Processes in the Pharma Manufacturing

2-Day Virtual Seminar Global Regulations for Equipment Qualification and Validation of Processes in the Pharma Manufacturing When: Wednesday & Thursday Sep 29 - Sep 30 , 2021.

Register Now     

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. The cost of non-compliance is therefore more than that of compliance. Are you in compliance with the FDA regulations for equipment qualification and validation in your manufacturing facility?

Learning Objectives:
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.
Qualify already existing systems and requalification
Write and execute sound protocols for equipment qualification (IQ, OQ, PQ) and process validation.
Be able to collect data, conduct tests, and obtain all necessary documents.
Understand the different types of validation.
Understand and know the principles of auditing the equipment qualification and validation.
To investigate true root causes of problems and to evaluate and prioritize solutions