Complying with Part 11 - Risk Management: Applying the GAMP® Good Practice Guide Electronic Records and Signatures Principles (T08)

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Level: Intermediate
ISPE CEUs: 1.3
Type: Classroom Training Course
Date Location Country Instructor(s)
This course is not currently scheduled, but may be offered at your company site. Please contact ISPE for more information.

This course has been updated to include the recently announced FDA Part 11 Inspection Assignments!

EU regulatory expectations as reflected in the draft revised Annex 11 will also be explored.

Description

Using the GAMP® Good Practice Guide: A Risk Based Approach to Compliant Electronic Records and Signatures as a resource, this course will give participants a practical introduction to the 21 CFR Part 11 regulation, which affects all aspects of computerized systems in the pharmaceutical industry and up-to-the-minute information on the status of FDA's current re-examination of the regulation, including a discussion of the Agency's latest Part 11-related guidance and inspection assignments. Taught through classroom presentations, workshop sessions, and team exercises, the course will present an overview of Part 11 including its objectives, benefits, and potential problems. This will be followed by a detailed analysis of Part 11 requirements, a discussion of electronic records and signatures, and key industry issues.

A central element of this course will be an explanation of the GAMP approach to 21 CFR Part 11 compliance, as well as compliance with other international regulations covering electronic records and signatures. The GAMP Guide provides timely and much needed direction on meeting current regulatory expectations for compliant electronic records and signatures. The Guide describes how a risk management approach may be used to ensure the compliance of regulated electronic records and signatures, through the application of appropriate controls commensurate with the impact of records and the risks to those records.

Course Modules

  • Background to 21 CFR Part 11
  • Final Guidance
  • Current Status of Re-examination
  • Newly Announced FDA CDER Inspection Assignments
  • Requirements of 21 CFR Part 11
  • 21 CFR Part 11 Practical Examples
  • GAMP Good Practice Guide - a practical resource to help
  • Examples of the Application of Risk Management Principles
  • International ER&S Regulations and Guidelines
  • Draft new EU Annex 11 and Chapter 4 - EU expectations for ER&S
  • 21 CFR Part 11 Definitions

Immediately apply the course objectives using the complimentary copy of the GAMP Good Practice Guide: A Risk-Based Approach to Compliant Electronic Records and Signatures

Take Back to Your Job

  • Interpret the 21 CFR Part 11 regulation
  • Be prepared for Part 11 inspections
  • Discuss international regulatory expectations for use and control of electronic records and signatures in computer systems used in the pharmaceutical and related life sciences industries
  • Apply Part 11 to specific systems and cases
  • Describe the GAMP risk management approach to Part 11 compliance
  • Understand Part 11 key issues
  • Apply lessons learned to systems within their own organizations

Attendance Suggested For

  • Quality assurance and quality control specialists, validation scientists, manufacturing supervisors, technical support personnel, engineers, MIS professionals.
  • All levels of management who need a fundamental understanding of the 21 CFR Part 11 regulation, and risk management approaches to achieving electronic record and signature compliance.

Community of Practice (COP)

This training course is of particular interest to existing and future members of the ISPE GAMP Community of Practice (COP).

Continuing Education Units 

ISPE will provide continuing education units (ISPE CEUs) for all North American and European courses.  CEUs are nationally recognized units of achievement designed for those individuals continuing their education in their chosen field or profession.  Verification of CEUs is based on attendance as well as satisfactory completion of all evaluation materials.  Statements of credit will be available for download in your ISPE account within four weeks of the completion of training.  Instruction for download will be sent when the CEUs are available.  One hour of education programming equals 0.1 ISPE CEU credits.

Last Update: 25 February 2014

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