This webinar is specifically designed for sponsoring biopharma and device companies who are outsourcing. It will help you get to grips with effective Vendors (including CRO, CMO, and other vendors) management used in the biopharma and device industries and your responsibilities as the sponsor.
It will also show you how to clarify roles and responsibilities, focus on oversight preparation and planning including understanding insight vendor performance measurement including metrics and key performance indicators. This webinar will instruct the participants how to set up maintain and update vendor oversight to ensure compliance.
Learning Objectives:
- Setting up vendor oversight
- Inspector expectations
- Selection of CROs to meet oversight requirements
- Ensuring clarity of roles and responsibilities
- RFI and RFP
- Contractual consideration for oversight
- The oversight/quality plan
- Effective planning
- Vendor performance including measuring vendor
- performance metrics and KPIs
- Auditing vendors
- Maintaining effective communication with your vendors
- Deliverables and analyzing performance trends
- Troubleshooting problems and escalation with vendors
- Documentation of oversight for regulatory inspection
Why Should You Attend:
A large number of FDA and EU inspection observations can be traced back to deficiencies in vendor oversight at an organization. This webinar will provide step by step instructions to ensure vendor oversight for FDA and EU regulated organizations.
This session will familiarize participants with how to generate documentation to demonstrate vendor oversight and what is expected including key tools and templates which are used. You will learn how to remain compliant over the course of using vendors.
Instructor Profile:
Dr Laura Brown is an independent pharmaceutical QA and training consultant and the Course Director for the MSc Clinical Research, School of Pharmacy, University of Cardiff. Laura is an expert in outsourcing pharmaceutical research projects including CRO selection, audit and management.
She has more than 20 years' experience in the pharmaceutical industry in a number of senior roles and has worked for several companies, including GlaxoWellcome, Hoechst Marion Roussel, Farmitalia and Phoenix International in outsourcing pharmaceutical projects.
She has worked in several vendor selection and management roles which have included reviewing quality and performance of CROs and has advised companies on how to implement quality systems for CRO selection and management.