Practical Computerized and Automated System Validation – Patient risk-based Approach
Two Days Training Session
Description
This Training session focuses on developing and implementing regulated digital and computerized systems with an appropriate level of documented evidence to satisfy Regulatory expectations. The hands-on training targets deliverable document content and how to avoid rework and unnecessary expense through a proactive approach based on patient safety. The core elements of a satisfactory digital and computerized validation program will be emphasized.
Contents
Topics to be discussed include:
- The regulatory expectations for computer validation
- 21 CFR part 11; GUI-0050 and EU GMP Annex 11 and there are implications for common regulations
- The implications of GAMP 5 on computer validation
- Discover a GDPR Compliant Approach to Software Services
- Relevant FDA warning letters
- Science-Based Quality Risk Management
- Data Integrity Design and Validation Consideration
- Life Cycle Phases of Computerized Systems
- The tasks and deliverables expected for computer validation
- Why do validation processes vary so much
- Strategies for Practical, yet Defensible Computer Validation
- Sops required for system operation and maintenance
- An active discussion of part 11 examples and audience questions
- Move from Paper to Electronic Systems
- Manage Changes in Computer Systems
- Conduct Risk-based Revalidations and Periodic Reviews
Learning Objectives
- Understand how to comply with key FDA, Health Canada, and international CSV regulations and guidance, such as 21 CFR Part 11, GUI-0050, and EU GMP Annex 11
- Learn the fundamentals of computer system hardware and software
- Learn the skills to plan, implement, and document effectively validation activities for computerized systems
- and to assess them concerning their GxP compliance
- Know the purpose of each validation deliverable and gain hands-on practice creating each deliverable, including the Validation Plan, Requirements Specification, Test Plan, Validation Tests (IQ, OQ, PQ), Trace Matrix, Test Summary, and Validation Report
- Apply the principals and practices of computer system validation to various pharmaceutical computer system projects including Cloud/SaaS, COTS, spreadsheets, and custom-developed systems
- Develop a system description and user requirements suitable for manufacturing safe medicines.
- Comprehension of risk-based validation techniques and how to leverage these techniques to create efficient yet compliant validation approaches
- Learn how to manage electronic data using GAMP®5 and 21 CFR Part 11, GUI-0050, and EU GMP Annex 11
- Awareness of best practices and stakeholder expectations for computer system validation and software quality assurance (SQA) programs
WHO SHOULD ATTEND
This Training session 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 Training session is of special value to personnel seeking experience with computer validation and issues associated with FDA-regulated computer systems.
Education Approach
- This training is based on both theory and best practices used in the industry (FDA; ISPE, PDA, Health Canada, etc,
- Lecture sessions are illustrated with examples based on case studies
- Practical exercises are based on a case study, which includes role-playing and discussions
Speaker
Kossi Molley, PMP, LSSBB, Chemist, Certified Trainer
