Presented by: Donncadh Nagle, CQV Lead & Lecturer, Jacobs Engineering & TU DublinThis 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 science landscape […]
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: Sofia Santos, Module Lead Engineer, ValGenesis• Exemplify how process evidence and risk can work in sync• Contextualize the approach with the regulatory framework• Demonstrate the main applications of QRM integrated with CPV• Identify the advantages of evidence and risk IntegrationTakeaway Tools• Example of tools used to support the determination of the process parameters’ […]
Authors: Valerie Mulholland, Pharmaceutical Regulatory Science Team (PRST), Technological University DublinProfessor Anne Greene, Director PRST, Technological University DublinThe Pharmaceutical Regulatory Science Team (PRST) founded in 2005, carries out research into strategies to address the challenges and opportunities of implementing Science and Risk based decision making and manufacturing approaches. Since its inception, the PRST has continued […]
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