Validation of Automated Equipment  (Includes Webinar)
Applying the GAMP® VPCS Guide Principles

Date				Location	Country	Instructor(s)
19-20 November 2008				San Diego Classroom Training Series San Diego, CA	United States	Jim John

Description

Through workshop exercises, case studies and examples, this highly-interactive course will stimulate group and class discussion on key issues involved with applying validation principles to automated equipment. The course will follow the validation lifecycle in detail from requirement specifications, risk assessment, and design review to traceability management and development of test strategies to meet FDA expectations.

Participants will receive clarification on regulatory expectations and use this knowledge to develop the validation approach. Participants will have the opportunity to discuss their own practical situations with other participants and with the expert trainer.

This course is based on the work of the GAMP Forum, a technical subcommittee of ISPE. The GAMP Forum was established by representatives from major international companies to interpret and improve the understanding of regulations governing the use of automated systems in the pharmaceutical industry. It is based on material developed by the Joint Equipment Transition Team (JETT) Consortium, the Validation of Process Control Systems Special Interest Group (SIG), and GMA/Namur. Concepts from the Commissioning and Qualification Baseline® Guide are also applied.

Participants will receive a complimentary copy of the GAMP Good Practice Guide: Validation of Process Control Systems.

This course contains knowledge related to the CPIP^SM technical knowledge competency element Quality Systems. For complete information concerning the knowledge elements or the CPIP Credential, please visit www.ISPE-PCC.org.

Take Back to Your Job

• Key themes and concepts in the Good Automated Manufacturing Practice (GAMP) Guide for Validation of Automated Sytems in Pharmaceutical Manufacturing, GAMP 4 
• GAMP 4 knowledge for your practical experience of computer systems validation 
• Understanding of GAMP appendices on planning, management and operation 
• Regulatory requirements and expectations for the validation of equipment and process systems used in the pharmaceutical industry 
• Best practices from case studies and application of the GAMP process for defining a validation strategy 
• The ability to apply risk and impact assessment techniques 
• Ways to utilize good practice for development of user requirement specifications for equipment and systems 
• How to plan supplier assessments and devise test strategies for case study systems 
• How to apply these concepts and strategies to systems within one’s own organization

Attendance Suggested For

Quality assurance, quality control, validation personnel, engineers, MIS professionals, vendors (service providers/suppliers), project managers, and regulators

Community of Practice (COP)

Process/Product Development

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.