The successful delivery of manufacturing facilities, (including small, large, new, expansion, or renovation type projects) regulated by various authorities, poses significant challenges to manufacturers, engineering professionals, and equipment suppliers. These facilities are required to meet all applicable GxP regulations, and to comply with all other relevant local and international governing codes, laws, and regulations.
This classroom course is designed to improve the way in which the industry delivers regulated manufacturing capacity: improving the ability to meet documented process requirements, control risks within the manufacturing process, produce high-quality products and consistently operate to meet product and process requirements.
Course topics include: understanding and developing User Requirements, Risk Management Methodologies, Design Reviews, QRM, Verification Strategy, Acceptance and Release Reports, Change Management and a regulatory review of EU Annex 15 for Qualification and Validation, ICH Guides Q8 (R2), Q9, and Q10, and ASTM Standard E2500-07: Standard Guide for the Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment.
- Review of EU Annex 15 for Qualification and Validation, ICH Guides ICH Q8 (R2), Q9, and Q10, and ASTM Standard E2500-07: Standard Guide for the Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment.
2. User Requirements:
- Understand user requirements, how their role in the verification process, and how to develop “SMART”(specific, measurable, achievable, realistic and traceable) requirements.
- Discuss the information necessary to develop Requirements Documents that will support a science and risk based approach to qualification. Given the necessary information and a list of requirements, identify those that are necessary for product quality and those that are business / safety related.
3. Risk Assessment:
- Apply risk management methodologies throughout design and verification phases. Explain the link between risk assessments, design review, and quality risk management.
- Understand how to use risk assessment to assure control strategies are robust and to develop and identify "Critical Aspects" – the functions and features that must be “Qualified”.
- Understand and examine the development of a Verification Strategy that incorporates use of vendor testing, construction quality assurance, site acceptance testing, installation checks, and functional testing.
- Develop a typical schedule for a CQV program to understand the sequence of events and the timing of C&Q / Verification activities within the project life cycle to support planning.
- Understand the regulatory drivers for Design Review; be familiar with ASTM E2500 Design Review requirements, and implementation and the range of options for documenting Design Reviews. Evaluate Implementation and range of options for documenting Design Review including One Page Memo; Traceability Matrix, Pre approved protocol, and detailed documentation of detailed design review sessions.
- Know what is involved in a system Acceptance and Release report given requirements, critical aspects, and verification test results in compliance with a verification strategy.
5. Experienced SME’s:
- Examine options for better utilization of resources and conformance to GxP regulations and define organizational roles and responsibilities for risked based C&Q program implementation, including defining critical aspects, verification strategies, acceptance criteria, testing execution, and review and approval of test results.
6. Change Management:
- Define change management strategies to adjudicate planned departures from requirements and specification.
Who Should Attend
Project engineers, project managers, commissioning and validation professionals, engineering service providers, and quality assurance personnel involved in qualification and validation and regulatory. Intermediate practitioners of Commissioning and Qualification who want to understand and use the Science and Risk-based approach to Quality Risk Management.
This course will be of interest to those following the latest industry and regulatory initiatives, including application product and process understanding within qualification and the science- and risk-based approach with emphasis on commissioning and qualification of equipment and systems.