Presented by: Connie Hetzler, Global Head – Validation, Alcon Laboratories Takeaways: • Regulatory guidance evolution• Global harmonization of regulations• Knowledge management – As a system that supports content• Organizational management for a systematic approach• Key challenges – Trends and looking forward
Presented by: Donncadh Nagle, CQV Lead & Lecturer, Jacobs Engineering & TU Dublin This session features an article on a similar theme which I published this summer which highlights how emerging technology is empowering validation engineers to capture, share and transfer tacit knowledge. • Learn where Knowledge Management (KM) fits within the pharmaceutical and life […]
Presented by: Luiz Barberini, Operations Manager, External Manufacturing, Bayer Having a diverse group of suppliers can provide the expertise and innovation needed to outperform the competition. An effective supplier diversity process can have a powerful and positive effect on the strength and loyalty of any organization’s consumer base – but to implement a strong supplier […]
Presented by: Ken Shitamoto, Executive Director, Gilead Sciences • Define a validation program and GAMP5 V model• Define training scope for validation program and processes• Designing training curricula for validation team• Test/protocol execution training: Testing process and acceptance criteria review• Pre and post execution – Must dos and don’ts awareness• Data Integrity training in validation […]
Presented by: Emily Dickinson, MS, ASQ, CQA, Quality Assurance Manager, Criterium, Inc. • Quality In = Quality Out – Principles of supply chain management• Building a robust supplier management program• Handling material changes and variability• The importance of alternate suppliers• More than vials & stoppers – Effective shipping and distribution management• Vendor complaints – Addressing […]
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