FDA's new enforcement practices
Overview: Within the next few weeks and months the FDA will continue to conduct a series of Part 11 related inspections. Planned routine inspections will be extended to evaluate the companies' practices to ensure integrity, authenticity and availability of electronic records, the program is the long awaited next step for Part 11 and nevertheless it came as a surprise to the industry.
The FDA already has issued many warning letters related to inadequate integrity, security and availability of electronic records but also related to validation of software and computer systems. There are many questions about the program, what inspectors are looking at and to further steps. The webinar will have the answers. And using industry proven case studies attendees will learn how to prepare their organisation for trouble-free Part 11 related inspections.
Areas Covered in the Session:
FDA's current inspection and enforcement practices
FDA's new interpretation: learning from FDA guidance, and recent FDA conference presentations and discussions
Learning from FDA inspection reports
Part 11 and the new EU Annex 11: similarity and differences
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
15 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.
How to prepare for Part 11 Inspections
Who Will Benefit:
IT managers and system administrators
QA managers and personnel
Analysts and lab managers
Validation groups
Software developers
Validation professionals
Training departments
Documentation department
Consultants
Ludwig Huber, Ph.D., is Director of Labcompliance and Chief Advisor for global FDA compliance at Agilent Technologies. He is the editor of Labcompliance, the global on-line resource for validation and compliance issues for laboratories. He is the author of the books "Validation and Qualification in Analytical Laboratories, and "Validation of Computerised Analytical and Networked Systems", Informa Healthcare
moc.lenapecnailpmoclabolg@sranibew
http://www.globalcompliancepanel.com
Time: 10:00 - 11:15
Venue: Online Training, Wilmington
Cost: Price List: Live : $245.00,Corporate live : $495.00,Recorded : $295.00
More info:
Online Training