Understanding and Implementing FDA’S 21 CFR Part 11 2011
08 Feb 2011
Webinar
Understand 21 CFR Part 11 requirements and get a guidance how implement it in a cost effective way. Briefing about part 11 inspections.
Note: Use this promocode(117660) for 10% discount.
Why Should You Attend:
In 1997 the US FDA issued a regulation that provides criteria for acceptance by the FDA of electronic records, electronic signatures and handwritten signatures. The rule applies to all industry segments regulated by the FDA that includes Good Laboratory Practice (GLP), Good Clinical Practice (GCP) and current Good Manufacturing Practice (cGMP). Even the rule is more than 10 years old there still many questions related to the scope and real requirements of Part 11.
Attend this 21 cfr part 11 webinar to get a good understanding of current and future FDA requirements and provide steps, examples and tools for cost-effective implementation.
Areas Covered in the Seminar:
Overview on Part 11 history and requirements
Current and future FDA inspections with focus on computers and electronic records
Part 11 requirements that are NOT enforced any more
Going through individual requirements:
Validation
limited authorized access to system and data
archiving and retrieval of e-records
executing electronic signatures
binding signatures with records, training
Recommendations for implementation and documentation
Bringing existing systems into compliance with minimal effort
Responsibilities of vendors and users
Going through most common pitfalls
Going through frequently asked questions and answers
Preparing for Part 11 Inspections
Free Hand-outs : For easy implementation, attendees will receive
Part 11 Compliance Master Plan - Ideal to develop or update your company`s Part 11 program
Part 11: Step-by-step implementation
SOPs:
Define and Document Scope and Controls for Part 11
