Webinar On FDA's New Enforcement of 21 CFR Part 11
January 15, 2015 - Mississauga ON CACompliance Trainings
uttam@compliancetrainings.com
Phone:4169154458
FDA continues to enforce Part 11 through its new Part 11 inspection and enforcement program. Just in the last 3 years FDA issued more than 30 warning letters with Part 11 violations. Citations are related to inadequate integrity, security and availability of electronic records but also related to validation of software and computer systems. Areas Covered in the Session : FDA's current inspection and enforcement practices FDA's new interpretation: learning from FDA inspection reports Strategy for cost-effective implementation of Part 11: A six step plan Recommended changes to existing Part 11 programs to reduce costs Justification and documentation for the FDA and your management Going through case studies from laboratories, offices and manufacturing with graphical workflow of records, step-by-step description, recommendations for individual Part 11 requirements with justifications and documentation for the FDA and your management. Case studies how to avoid or respond to Part 11 related observations with corrective actions to fix current issues and preventive actions to prevent reoccurrence of the same or similar issues. How to prepare your company for Part 11 Inspections Who Will Benefit: A must attend webinar for all personnel / companies in the Pharmaceutical, API, Contract laboratories, Medical device, Clinical testing, CROs and IT consulting fields. The professionals who will benefit include all: IT managers and system administrators QA managers and personnel Analysts and lab managers Validation groups Software developers Validation professionals Training departments Documentation department Consultants