ExL’s 8th Trial Master File Summit
January 22-24, 2019 | Hilton Orlando Lake Buena Vista | Orlando, FL
15% off standard pricing rates using Discount Code AVOCAVIP
Join Avoca for the following session:
Thursday, January 24 – 9:10am | Main Conference Day Two
[Panel] Prepare for a TMF Inspection With a Quality Management System
- Manifest prioritization drivers in your metrics to avoid critical findings
- Hear examples of mock audits improving inspection readiness by informing process modifications
- Hear how various constituencies are involved in inspections
- Conduct audits in accordance with inspection trends and pending changes
- Survey common pitfalls for inspections and discuss how they may be avoided
Panelist:
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Janis Hall, MBA, Senior Consultant, The Avoca Group |
Moderator: Bryan Souder, Director, TMF Head, Merck
Panelists:
- Sheryl Crean, Director Quality Assurance Strategic Advice- Science Unit QA, GCP and PV, AstraZeneca
- Janis Hall, Senior Consultant, The Avoca Group
- Dawn M. Niccum, Senior Director of QA and Compliance, Inseption Group
- Melissa Umbehauer Chiasson, Senior Manager, Process, Training and Compliance, Takeda
- Stephanie Viscomi, Associate Director, Clinical Trial Office, Immunogen
To schedule a meeting with an Avoca representative at this event, contact us.
Webinar: TMF Inspection Readiness (IR): Avoiding IRregularities IRrespective of International Regulatory Agency
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