“Practical Application of Risk Management in Vaccine Compliance and Quality Assurance”
Regulators worldwide are moving towards a Risk Based Approach to the manufacture and control of Therapeutics. The FDA 21st Century cGMPs initiative, ICH Q9 and the recent publication of ASTM E2500
have all added significant weight to this shift. This workshop will provide hands-on opportunities to demonstrate how risk management is applied, develop risk based strategies and apply risk assessment to the manufacture and quality assurance of Vaccines.
Key issues to be addressed:
Defining risk management in relation to ICH Q8, ICH Q9 and ASTM E2500
Need for a risk based pragmatic approach to manufacture and distribution of Vaccines
Application of risk based principles to QA, compliance, product design and validation
Application of risk tools
Benefits of attending:
Evaluate the principles and practice of risk management in vaccine operations
Make compliance-based judgments based on risk management principles
Utilise risk evaluation techniques to analyse vaccine products,
operations and compliance
Propose control strategies to mitigate unacceptable risk and loss to
organisations
Use risk tools in a regulatory and compliance environment
Who should attend:
Bioprocess, manufacturing and production scientists
Quality assurance and control professionals
Compliance and Validation managers
Research and viral safety scientists
Masterclass Leader
SteveWilliams, Director, SeerPharma
Steve has over 35 years experience in the Biotechnology and the Pharmaceutical industry in Quality Assurance, Manufacturing and Consulting. He has conducted numerous FDA and TGA compliance audits and gap analysis for many international companies. Steve managed Vaccine quality control and Influenza Vaccine manufacture at CSL for 17 years. He then worked at Faulding Pharmaceuticals (now Hospria), where he was the Quality Assurance Manager for the complete range of sterile and oncology products. In 1989 he co-founded SeerPharma, Asia/Pacific’s largest Life Sciences professional services consultancy.
This is your best sales and marketing opportunity of the year. If you are serious about being positioned as a market leader in the vaccines field, then this is the event you need to be at!
