FDA’s new interpretation: learning from FDA inspection reports
FDA’s current inspection and enforcement practices
Recommended changes to existing Part 11 programs to reduce costs
Strategy for cost-effective implementation of Part 11: A six step plan
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
Justification and documentation for the FDA and your management
How to prepare your company for Part 11 Inspections
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
Who should Attend
QA managers and personnel
IT managers and system administrators
Validation groups
Analysts and lab managers
Validation professionals
Software developers
Documentation department
Training departments
Consultants
Past Events
FDA’s New Enforcement of 21 CFR Part 11 2019 - 13 Mar 2019, Webinar (82613)
Important
Please, check "FDA’s New Enforcement of 21 CFR Part 11" official website for possible changes, before making any traveling arrangements
Event Categories
Business: Quality assurance
Government & Global Issues: Law & Regulations
Technology: Information Technology (IT), Software & Applications, Software engineering