This webinar presents an overview of validation and change control as they pertain to pharmaceuticals manufacturing. Dr. Amer will review the general validation approach, define what is meant by a validated state, and identify the need forhaving a change control system and procedure in place. He will then proceed to define what a change control system entails and propose an outline of a robust change controlprocedure. The concept of validation life-cycle will also be introduced and its meaning discussed at length. The importance of change control in maintaining the validated state and closing the validation cycle will be discussed.
Managing changes in pharmaceuticals manufacturing through implementing a change control procedure is a regulatory requirement. Manufacturers of drug products are required to maintain the operations in a validated state and to have a change control. This webinar is aimed at introducing the concept of a validated state and managing change within the validation life cycle. Dr. Amer will draw on his vast experience in the pharmaceutical industry to explain the concepts and provide many real life examples to support these concepts.
By attending this presentation you will learn:
· Definition of validation
· Regulatory imperatives
· How validation is conducted
· Validation approach
· The validated state and the importance of maintaining it
· Need for change
· Where changes happen
· Types of changes
· Regulatory requirements
· The Validation Life Cycle
· Definition of a change control system
· Importance of change control
· How to maintain a validated state after implementing change control
· Change control procedure
· Change request form design
· Criteria for emergency changes
· The types of change and their potential impact on the validated state
· What a change control system entails and its importance
