Process Validation (PV) Workshop:
Life Cycle Management & Risk Based Approaches
This course will provide important information regarding the adoption of lifecycle validation practices by various regulatory authorities; the context of these developments, how they impact companies and what the key actions will be for companies operating in Singapore or the wider Asia Pacific region.
Key Takeaways
Attendees will gain insights into how regulators and industry are thinking about and approaching changes in the lifecycle validation practices in the US, EU and international markets and will include key principles such as:
- ICH and other international regulatory guidance
- Regulatory trends and the current state of regulatory expectation
- Evolution of quality and validation into all aspects of Product
- Application of science and risk based thinking
- QbD principles and how these will impact existing operations
- What this means for new and existing or legacy products
- Expected approaches to process performance and continuous process monitoring
- The role change management plays in this new paradigm.
- A look into the future - what to expect on the horizon
Who should Attend
- Quality and validation practitioners, managers and operational staff who want to understand and utilise science and risk-based validation approaches.
- Quality assurance, validation and technical professionals, management, service providers, and operations personnel involved in quality, validation and regulatory decision making.
Take Back to your Job
- Understanding of science and risk based thinking, the drivers behind changes in GMP requirements for this and expectations including emerging regulatory views in US and EU.
- An overview of ISPE's PQLI initiative parts 1 to 4 covering development, CQAs, CPPs, control strategies and the case studies as well as the role of change management and the technical and scientific methodology for adopting a process performance and product quality monitoring system (PP&PQMS)
- An update on current developments in Process Validation (including recent ISPE work and discussion papers in this area)
- Relevance of these principles to ICH guidance on Quality Risk Management (Q9) and Pharmaceutical Quality Systems (Q10)
- Understanding of how this may impact your validation program; now and in the future
Program Outline
Session 1:
Science and risk based approaches to Product Realisation including Process Validation regulatory guidances, ISPE PQLI Practical Guides work and current trends in Process Validation
Session 2:
Product and Process Understanding and Quality Risk Management (ICH Q9 and FDA Process Validation Stage 1)
Session 3:
Process Validation Stage 2 - Facility/Equipment qualification and number of PPQ/PV batches.
Session 4:
Continued (Ongoing) Process Verification and monitoring, including implications on legacy products (Process Validation Stage 3)
Session 5:
Pharmaceutical Quality System - Process Performance and Product Quality Monitoring System (PPPQMS) & Change Management (ICH Q10)
Session 6:
Process Validation for CMOs and during Tech Transfer and looking to the future - what to expect.
Course Instructor:
Maurice Parlane, Director, CBE Pty Ltd, and New Wayz Consulting Ltd. is a professional engineer with 30 years ' experience in technical and consulting roles within the biopharmaceutical industry, including 19 years as an industry consultant.
Prior to this; he held senior engineering and manufacturing roles within the Glaxo group of companies.
His core skills and experience are in manufacturing and compliance management; process design and improvement; risk management, validation and operational excellence. Maurice has assisted numerous organisations to establish, improve or scale-up manufacturing operations and GMP compliance in Australasia and the Asia Pacific region.