KEY HIGHLIGHTS WORKSHOP 2019

Transcription

1 KEY HIGHLIGHTS aenvironmental Monitoring afacility Design apractical Case Studies avisual Inspection aclean Room Behaviours aprocess Simulations arecent 483s, warning Letters and EU Observations WORKSHOP February 2019 Radisson Blu, Banjara Hills, Hyderabad

2 ABOUT THE TRAINER : Ian Symonds, CBiol MRSB, Independent Pharmaceutical Consultant, former Head of Aseptic Strategy and Intelligence, GlaxoSmithKline. Responsible for setting and monitoring Quality standards for GSK s Global Manufacture and Supply pharmaceutical sterile manufacturing operations worldwide. Part of the team that rewrote sections of the FDA 2004 aseptic manufacturing cgmp guideline and the 2007 PQRI (FDA) white paper - Post Approval Changes to Sterile Products. Held a corporate governance and consultancy role supporting the GSK Vaccines manufacturing operations and Pharmaceutical Development (R&D). Awarded the honour of Senior Fellow GSK. Principal author and editor of PHSS Technical Monograph No.20 (Bio-contamination characterisation, control, monitoring and deviation management in controlled / GMP classified areas). The team that produced this monograph included representatives from the UK, French and Irish regulatory authorities. Historical industrial involvement was through membership of Parenteral Drug Association (PDA) Aseptic Task Group and US Product Quality Research Institute (PQRI) Aseptic Task Group and International Society for Pharmaceutical Engineering (ISPE) technical team. Former Board member of the British Chapter of the PDA. Contributing author for PDA Technical Report No1 - Validation of Moist Heat Sterilization Processes. Part of ISPE technical team involved with the development of Restricted Access Barrier Systems (RABS) definition published in the Pharmaceutical Engineer Nov Presented the EU industry position as European Federation of Pharmaceutical Industries and Associations (EFPIA) representative to the EU inspectorate EMEA meeting for the changes to the EudraLex Vol 4 Annex update. He is a Chartered Biologist and Member of the Royal Society of Biology. Prior to working for GSK he was a Medical Laboratory Scientific Officer within the UK Public Health Laboratory Service (now the Health Protection Agency). External professional involvement includes membership of PHSS where he is an active member of the Biocontamination Control Interest Group. Won the George Skies memorial award in 2016 for the best paper of 2016 in European Journal of Parenteral & Pharmaceutical Sciences

3 ABOUT THE TRAINER : Mike Davies, CBiol MRSB former Director of Aseptic Strategy and Intelligence for GlaxoSmithKline and Principal author of GSK Sterile standards and PHSS Technical Monograph No.20. Has over 38 years experience within the pharmaceutical industry working for GSK and is regarded as a world leading expert in Sterile manufacturing and control. His advice and leadership have been sought internationally both within GSK and from external industry leading organisations such as PHSS, ASCCA and PDA, with Mike presenting on subjects as diverse as Causes of Contamination within Aseptic Areas, EU Annex 1 Revision, False Positive Sterility Test Causes, WHO Annex 6 requirements and Environmental Monitoring Approaches. Within GSK as Director of Aseptic Strategy and Intelligence, he was the leading author and contributor to the Global Sterile Policy and Guidance documents for Sterile Manufacturing and has conducted numerous Aseptic Manufacturing Reviews inspecting processing, controls and engineering. Countries visited include USA, Canada, Mexico, Brazil, India, China, Saudi Arabia and Australia. In 2014 he was one of the principal industry authors and editors of the leading cgmp text on aseptic manufacturing, PHSS Bio-contamination Technical Monograph No.20, whose review body included MHRA. He also co-wrote the scientific paper for the evaluation and selection of suitable incubation temperatures for environmental monitoring which was awarded the prestigious George Sykes Memorial Award for best paper in the 2016 European Journal of Parenteral and Pharmaceutical Sciences. Prior to his global role, Mike hosted many regulatory inspections, acting as Senior Sterile Products QP for over 15 years, and attended review sessions at regulatory headquarters in US (FDA), UK (MHRA) and Europe (BGA). Since 2007, he has co-hosted and presented regularly at Global Aseptic Manufacturing Workshops in London, Europe and Asia.

4 PROGRAMME : TIME 08:30 Registration and Networking 09:30 Pre Course Quiz DAY 1, THURSDAY PROGRAMME 09:40 Fundamentals of Microbiology for aseptic control and understanding 10:10 Facility Design, Grades, HEPAs, airflows, RABS, Isolators, Integration, Automation 11:00 Refreshments and networking 11:30 Clean Room Behaviours, Grade A Continuity, Clean room licencing 12:10 The origin and future of Regulations within EU and USA 13:00 Lunch & Networking 14:00 Environmental Monitoring in Context: Design and execution, optimisation, trending, investigations, the future : Interactive sessions and lectures : Part 1 15:30 Refreshments and networking 16:00 Environmental Monitoring in Context: Design and execution, optimisation, trending, investigations, the future : Interactive sessions and lectures : Part 2 17:30 End of conference day 1 DAY 2, FRIDAY 09:30 Principles of sterilisation, types moist and dry heat, filtration, gamma eto Devonport Incident, Cleaning and disinfection 10:15 Inspection: Visual inspection, manual & automated inspection 10:45 Data Integrity 11:15 Refreshments and networking 11:45 EU Annex 1 revision. The promise and Reality. Impact on Global Regulations 12:30 Process Simulations: Design, Execution and Interpretation 13:00 Lunch & Networking 13:45 Recent 483s, warning Letters and EU Observations. Why inspections fail. 14:30 Refreshments and networking 14:45 Case Studies: facility issues, bulk and secondary issues, Lab issues 16:00 Post course Quiz 16:30 End of Conference PRICING Delegate (Includes access to two day programme only) Standard Amount Indian (INR) 36,000 International (USD) 800/- * 18% GST as applicable * Group booking discount on 2 or more delegates

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