34th SQA Annual Meeting and Quality College

RQAP re-registration units: 4 GCP, GLP

*Note: Participants must attend 100% of the training course to receive a certificate of attendance documenting RQAP re-registration units.

Description
This course is designed for Validation, Quality, IT, and Business personnel responsible for implementing and using regulated computer systems in the pharmaceutical, biotech and medical device industries. The course is of special value to personnel seeking experience with computer validation and issues associated with regulated computer systems. The course is especially designed for attendees seeking a thorough introductory level of understanding, yet is also designed to be valuable to those with prior experience seeking to remain current with industry trends and approaches.

Objectives
At the end of the course, the participants shall be able to: 

• Provide a thorough understanding of computer system validation by providing a framework on how to execute the System Life Cycle.
• Address how 21 CFR Part 11 (electronic record/electronic signature requirements) fits into the validation process.
• Be familiar with expected content for computer validation deliverables through workshop exercises and examination of example documents, as well as how to develop the validation rationale for a variety of circumstances.

Target Audience
This course is designed for Validation, Quality, IT, and Business personnel responsible for implementing and using regulated computer systems in the pharmaceutical, biotech and medical device industries. The course is of special value to personnel seeking experience with computer validation and issues associated with regulated computer systems. The course is especially designed for attendees seeking a thorough introductory level of understanding, yet is also designed to be valuable to those with prior experience seeking to remain current with industry trends and approaches.

Agenda

• Understanding the Regulations and Guidelines.
• Identifying the Components of the System Life Cycle.
• In-depth look at the Validation Deliverable.
• Planning, Conducting and Documenting the Computer Validation Audit.