Quality Systems Element Computerized System Validation

Training / Workshop Description: Quality Control Laboratory Computerized Systems and Software’s impacting on tests results and Data Integrity must be identified, and the risks in their use evaluated. From Chromatographic Data Systems (CDS) through to non-complex systems in a regulated biotechnology, pharmaceutical and medical device manufacturers are required to validate GxP-critical systems. The learning will be heavily supported by the high level of relevant and recent practical knowledge of the presenters involved and the use of example test sheets and real-life examples.

Topics: • Regulatory Rules & Guidance and an overview of Good Automated Manufacturing

Practice (GAMP) • Get a thorough understanding of how the CSV process fits into your Software Life Cycle

and the purpose of each validation deliverable. • Risk Assessments and how they can help determine the depth and scope of testing

required. Methodology and implementation model for a risk-based approach to CSV. • 21 CFR part 11 and it is implications for common regulations. • Sustainable Computerized System Operational Phase. • Understand supplier audit concepts and the importance of the user/supplier relationship. • Audit Validated Systems Duration: 6 hours Who should attend? • Quality Assurance Representatives • Quality Control Representatives • Auditors • Engineering Representatives What is Included? • Training Material

• Hard Copy • Participation Certificate Continuing Education Units: • ASQ – 0.6 RU