Part 11 inspections from the FDA and ways of steering clear of inviting 483’s and Warning Letters

[Adam Fleming]

The ongoing Part 11 inspection and enforcement program is the mechanism by which the FDA continues to enforce implementation of Part 11. Using this method, this regulatory agency has, in just the last four years, issued more than 30 Warning Letters for deviations from Part 11. The most important reasons for which citations get issued by the FDA relate to insufficient integrity, security and availability of electronic records, as well as validation of software and computer systems.

Get used to what the FDA looks for

So, for an organization that is covered by Part 11; it is necessary to understand what the FDA inspectors are looking at and what their major findings are. Teaching the ways of doing this will be the objective of a learning session that is being organized by Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance.

At this webinar, the speaker, Dr. Ludwig Huber, Ph.D., who is the director and editor of Labcompliance the global online resource for validation and compliance and author of books on compliance, will provide the answers to how to avoid FDA Part 11 citations. To enroll for this webinar, just visit http://www.compliance4all.com/control/w_product/~product_id=500980

Ways of avoiding 483’s and Warning Letters

At this webinar, Huber will use industry proven case studies on how to avoid 483 inspectional observations and Warning Letters. He will show to attendees the ways of preparing their organization for trouble-free Part 11 related inspections.

This webinar is of immense value to important professionals such as IT managers and system administrators, QA managers and personnel, analysts and lab managers, validation groups, software developers, , training departments, documentation departments, and Consultants.

Huber will cover the following areas at this webinar:

o  FDA's current inspection and enforcement practices

o  FDA's new interpretation: learning from FDA inspection reports

o  Part 11 and the new EU Annex 11: similarity and differences

o  Strategy for cost-effective implementation of Part 11: A six step plan

o  Recommended changes to existing Part 11 programs to reduce costs

o  Justification and documentation for the FDA and your management

o  6 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.

o  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.

o  How to prepare for Part 11 Inspections