The Webinar will focus on the importance of ensuring that electronic record/electronic signature (ER/ES) capability built into FDA-regulated computer systems meets compliance with 21 CFR Part 11. This includes development of a company philosophy and approach, and incorporating it into the overall computer system validation program and plans for individual systems that have this capability.
In this webinar, we will cover the role Annex 15plays in Validation and Qualification. We will discuss other related documents that provide for other aspects of what Annex 15 is covering including FDA requirements. The subject of Validation applies to chemical processes, manufacturing processes, computer processes, product approval processes and others. The tools used for validating these processes are quality management, project management, risk management and product life cycles.
Price:$250.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 firstname.lastname@example.org Event link