Equipment and QMS Software by Verification Process
- Start Date:
- Wednesday, 8 March, 2017
- End Date:
- Wednesday, 8 March, 2017 11:30am
- Health & Nutrition
Overview: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". Why should you 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. Areas Covered in the Session:Verification or Validation-FDA ExpectationsThe Project V&V PlanAn FDA-accepted Documentation "Model"Product and Process/Test Facilities/Equipment Software V&V Who Will Benefit:Senior management in Drugs,Devices,Combination Products,Biologics,Dietary SupplementsQA / RASoftware development,Programming,Documentation,Testing teamsR&D Speaker Profile:John E. Lincoln is a medical device and regulatory affairs consultant. He has helped companies to implement or modify their GMP systems and procedures, product risk management, U.S. FDA responses. Contact Detail: Compliance4All DBA NetZealous,Phone: +1-800-447-9407Email: support@compliance4All.com
Conference organized by Compliance4ALL
Compliance4All is a professional trainings provider for the regulated industries. It offers professional trainings for regulatory compliance professionals and offers innovative strategic consulting and advice to a broad range of organizations. These services help them to be compliant with regulatory requirements. .Compliance4All has a panel of acclaimed Experts whose professional trainings help regulatory professionals and organizations in a number of ways and take them to their goal of meeting regulatory requirements. Compliance4All offers path breaking professional training solutions to organizations that help them address pain areas and overcome the challenges and difficulties associated with meeting regulatory requirements.
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