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.
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:
Science and risk based approaches to Product Realisation including Process Validation regulatory guidances, ISPE PQLI Practical Guides work and current trends in Process Validation
Product and Process Understanding and Quality Risk Management (ICH Q9 and FDA Process Validation Stage 1)
Process Validation Stage 2 - Facility/Equipment qualification and number of PPQ/PV batches.
Continued (Ongoing) Process Verification and monitoring, including implications on legacy products (Process Validation Stage 3)
Pharmaceutical Quality System - Process Performance and Product Quality Monitoring System (PPPQMS) & Change Management (ICH Q10)
Process Validation for CMOs and during Tech Transfer and looking to the future - what to expect.
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.