The Center for Professional Innovation & Education, Malvern, PA
04/16/08
Who Should Attend
Attendance will be beneficial to personnel directly involved in process/product development and process validation as well as beginning or seasoned operational personnel who will eventually participate in such efforts. This includes Quality Control and Quality Assurance personnel. Individuals in management who interact with the above or interact with regulatory agency inspectors to rationalize or defend validation programs will also benefit from attending this course. There are no particular requirements for this course, but a basic knowledge in general science and processes is helpful.
Learning Objectives
By the end of the 2-day course you will:
- Understand the importance and underlying principles of process validation
- Understand the new FDA perspective of a “Process Validation Life-Cycle” that starts at the Design phase (Process/Product Development) and continues through Confirmation, Monitoring and Assessments 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 and program and avoid costly delays and rejections by regulatory agencies
Course Description
Process validation is not a curse, invented by regulators, pushed onto a company by QA staff. Process validation 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 leads to risk-based, reasonable and supportable informed decisions and planned activities. 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.
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