Verification vs Validation-Product, Process or Equipment and QMS Software
May 5, 2021 - CA USCompliance4All
compliance4all14@gmail.com
Phone:8004479407
Overview: The verification and validation of regulated software is coming under increased scruinty by the U.S. FDA. This webinar will address the use of the FDA, GAMP, 21 CFR Part 11,"Electronic Records"/"Electronic Signatures", IEC 62304, and other applicable industry software validation models, coupled with the ISO 14971/ICH Q9 Product Risk Management models, to plan, structure, run, and document acceptable software validations. The FDA and other regulatory agencies have stated that software validation can only be accomplished effectively if "risk-based". How can this be done in the "real-world". This webinar will address software that is: As-Product In-Product Process and/or In Production and Test Equipment and The Quality System/CGMPs A manufacturer is responsible to identify these requirements and implement them into an effective software V&V process. Why you should Attend: Software has become pervasive in medical devices themselves, and in the controlling, running and monitoring of medical product processes, whether they be in the pharmaceutical, medical device, biologics or dietary supplements industries. A quick review of Internet forums will show much confusion about the subject. Software is being developed for medical imaging, and even thought control of computers. It is increasingly being used for e-records and e-signatures.