- Understand the importance and underlying principles of process validation
- Understand the new/revised concepts as stated by the FDA’s new Draft Guideline on Process Validation and its impact on how process validation activities are carried out
- Understand the new FDA perspective of a “Process Validation Life-Cycle” that starts at the Process Design phase (Process/Product Development) and continues through Process Qualification (Confirmation) and Continued Process Verification (Monitoring and Assessment of the process effectiveness)
- Be able to set up process validation protocols and reports that meet current FDA, WHO, PIC/S and EU regulations
- Prepare and defend your own process validation approach/ program and avoid costly delays and rejections by regulatory agencies
Process validation is not a curse invented by regulators and pushed onto a company by QA staff. Instead, it is a legal requirement in the pharmaceutical industry. The concept of process validation is recognition that quality cannot be tested into the product and must be designed into the process/product to reduce the risk of non-conformances during/after manufacturing.
This course provides practical guidance on compliance with the requirements of process validation that lead to risk-based, reasonable and supportable informed decisions. Compliance with the requirement for process validation must go hand in hand with sound science for the proper evolution of critical processes.
The course includes process validation examples from pharmaceutical, biologic and biopharmaceutical manufacturing processes. This includes the manufacturing of the API and the finished drug products.