Created by: Valerie Mulholland, Senior Director / Principle Consultant, GMP Services Ltd & 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 […]
Presented By: Tara Scherder, partner, Synolo Stats, LLC MOVING-TO-OBJECTIVE-DATA-DRIVEN-DECISIONS-THE-WHO-WHAT-WHEN-WHERE-WHY-AND-HOW-OF-STATISTICSDownload
Presented by: Connie Hetzler, Global Head – Validation, Alcon LaboratoriesTakeaways:• 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 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 […]
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