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Event Details


FDA continues to enforce through its new 21 CFR Part 11 inspection

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Who should attend?

Analysts Regulatory Affairs Training Departments Documentation Department Consultants


The webinar will have the answers. In addition, 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
Strategy for cost-effective implementation of Part 11: A six step
Justification and documentation for the FDA and your management

Who Will Benefit:
QC Managers
QA Managers and Personnel
IT Administrators
Regulatory Affairs
Training Departments
Documentation Department

Speaker Profile:
Ludwig Huber Ph.D., is the director and editor of Labcompliance
the global online resource for validation and compliance. He is the
author of the books "Validation and Qualification in Analytical
Laboratories" and "Validation of Computerized Analytical and
Networked Systems, Informa Healthcare". He has given more than
300 presentations mainly on GLP/GMP, 21 CFR Part 11 and
Validation around the world.

Event Fee: One Dial-in One Attendee Price: US$150.00

Contact Detail:
Compliance4All DBA NetZealous,
Phone: +1-800-447-9407


One Dial-in One Attendee Price: $150.00


Event Manager

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