Online Webinar on FDA 2014 - Understanding and Preparing for FDA's on-going Part 11 Inspection Program

Overview:
FDA continues to enforce Part 11 through its ongoing Part 11 inspection and enforcement program. Just in the last 12 months FDA issued more than 10 warning letters with citations 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. There are many questions about the program, e.g., what inspectors are looking at what are major findings.
The webinar will have the answers. And using industry proven case studies on how to avoid 483 inspectional observations and warning letters attendees will learn how to prepare their organization 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 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.
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 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
Quick Contact:
GlobalCompliancePanel
USA Phone:800-447-9407
Fax: 302-288-6884
webinars-AT-globalcompliancepanel.com
http://www.globalcompliancepanel.com
Event Link - http://bit.ly/1jTpg78