GoingToMeet

Sterilization validation is a topic that results in many audit observations from the FDA and international regulatory bodies. Proper understanding of the principles and requirements of the related standards is crucial to proper compliance. In addition, understanding the requirements and integrating them early in the product design can lead to quicker time to market. This seminar will help RA/QA staff understand the basic principles as well as the standards and regulations. This will be useful when reviewing validation plans, performing internal audits and dealing with regulators. It is also beneficial to R&D staff to understand the requirements so they may be incorporated into the design inputs correctly.