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Understanding and Implementing FDA’S 21 CFR Part 11-webinar

Webinars - Understanding and Implementing FDA’S 21 CFR Part 11-webinar

By : Compliance Online

Date : 2011

Location : United States US / Palo Alto

Video 01h 16m
Description :

Understand 21 CFR Part 11 requirements and get a guidance how implement it in a cost effective way. Briefing about part 11 inspections.

Keywords :

compliance, compliance training, event, conferance, webinar, FDA, GCP, GLP, 21 CFR Part 11, pharmaceutics, softwares developers

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.


Free Hand-outs on demand :

  • 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
    • Electronic Audit Trail: Specifications, Implementation, Validation
  • Gap analysis/checklist: 21 CFR Part 11t


Who Will Benefit:

  • (Bio)Pharmaceutical Companies
  • Device manufacturers
  • Manufacturers of pharmaceutical starting material
  • Clinical Laboratories
  • Software developers
  • IT managers and system administrators
  • QA managers and personnel
  • Users of computer systems in FDA regulated environments
  • Validation professionals
  • Training department
  • Documentation department
  • Consultants


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



Instructor Profile:


Ludwig Huber, Ph.D., is Director of Labcompliance and Chief Advisor for global FDA compliance for Agilent Technologies. He is the editor ofwww.labcompliance.com , 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 Computerized Analytical and Networked Systems", Informa Healthcare. For more information, visit Dr. Huber's website: www.ludwig-huber.com .


Recorded webinar and reference materials will be available on your account after purchase.

Understanding and Implementing FDAS 21 CFR Part 11

Product Type : On Demand Webinar

Author : Dr. Ludwig Huber

Video 01h 16m

Languages : English

Organizer : Compliance Online

ComplianceOnline is a Regulatory Affairs Professionals Society(RAPS) RA Professional Development Portal provider. ComplianceOnline is committed to enhancing the ongoing professional development of regulatory affairs professionals and other stakeholders through appropriate regulatory affairs learning activities and programs ComplianceOnline has agreed to follow RAPS-established operational and educational criteria