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

ISPE CEUs*: 1.5 (including Webinar) Type: Classroom Training Course

Upcoming Dates and Locations

Date				Location	Country	Instructor(s)
14-15 April 2008				Chicago Classroom Training Series Chicago, IL	United States	Jim John

Description

Using the new 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. Taught through a combination of introductory Online Essentials, 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. This course will also provide 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.

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.

A complimentary copy of the Good Practice and Compliance for Electronic Records and Signatures: Complying with 21 CFR Part 11, Electronic Records and Electronic Signatures, Part 2 will be provided to each participant.

This course contains knowledge related to the CPIP™ technical knowledge competency elements Information Systems and Quality Systems. For complete information concerning the knowledge elements or the CPIP Credential, please visit www.ispe-pcc.org.

Webinar Learning Objectives

•  Describe why the regulation exists and the purpose and reasoning behind Part 11
• Explain how and why Part 11 originated 
• Understand the structure of the regulation 
• Compare Part 11 to other GxP regulations 
• Discuss the history of the FDA and related industry guidance
  

Take Back to Your Job

• Interpret the 21 CFR Part 11 regulation
• 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.
• 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 seminars and courses, including educational programming at the ISPE Annual Meeting. CEUs are nationally recognized units of achievement designed for those individuals continuing their education in their chosen field or profession.

Delegates attending European seminars and courses will receive a Certificate of Attendance, as ISPE CEUs are currently not offered at European events. Verification of CEUs is based on attendance as well as satisfactory completion of all evaluation materials. Statements of credit will be mailed within four weeks of evaluation materials. One hour of education programming equals 0.1 ISPE CEU credits.

About On-line Essentials

This course includes On-line Essentials, a pre-recorded, Web-based session that provides a review of the basics prior to the classroom course. You will receive information via email on how to access the On-line Essential two weeks prior to the start of the training event.