This course is designed to connect the Risk Assessment to Process Validation. Learning the business sense and what drives process validation to be performed. Using the Global Harmonization Task Force guidance and FDA requirements, this course walks you through the steps of process validation. It starts with understanding the planning process of process validation and the tools to use. This includes discussion on sampling plans to prove out the process. The student will perform activities for Installation Qualification, Operation Qualification and Performance Qualification. It also includes how to report on the qualifications and tie them to process control plans for process monitoring. Lastly, understanding when process re-validation is needed.

Course Agenda – Day One
Agenda/Course Objective – Terminologies and Definitions – Validation Plan/Protocol Activity – Tools for Validation – Validation of Processes
Course Agenda – Day Two
Installation Qualification – IQ Activity – Operation Qualification – OQ Activity – Performance Qualification – PQ Activity – Final Report, Monitoring and Re-validation – Control Plans -
Summary, Conclusion and Evaluation
Included with the class is the course book, materials and a certificate of completion.

Training Location:
Country Inn and Suites
320 Oak Avenue
Menomonie, WI 54751
715-235-5664

Click Here for a printable map.

If event is identified as full, call River Systems at 715-235-0329 to inquire about possible openings.

August 16-17, 2011 – Country Inn & Suites, Menomonie, WI
Price: $595 per person – Order On-Line through PayPal or with major credit card.