Presented by: Emily Purchase, Project Manager, Quality, Compliance & Regulatory, CAIHaving a diverse group of suppliers can provide the expertise and innovation needed to outperform the• Establish stability protocols to deliver the right analytical informations• Establish key information to manage changes to the stability programs• Identify and investigate stability deviations to support product stability profile• […]
Presented by: Luiz Barberini, Operations Manager, External Manufacturing, BayerHaving 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 diversity […]
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 programTakeaway […]
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 minor […]
Presented by: Rucha Patel, Manager, Quality Assurance and Regulatory Affairs, MIMOSA Diagnostics• Introduction to Risk Management according to ISO 14971• Development of a complaint handling process including inter-connections with Risk Management using IM What is a Product Recall? Recall v/s Market Withdrawal v/s Stock Recovery Some examples of Product Recall How do Recalls affect a […]
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