This vendor management webinar will show you how to choose the right vendor, onboarding and set up, manage vendor performance, manage issues and ensure compliance with current FDA regulations and ICH guidelines and have a smooth-running clinical study.
This presentation will instruct the participant on how to ensure the correct vendor for their organization and clinical study. The process starts with a cohesive team for the sponsor to define vendor specifications, internal and external planning, pre-selection, evaluating, negotiation, contracting and selection.
What do the Regulations mean?
Vendor oversight - Where do you start?
Why Should You Attend:
Sponsors are responsible for vendor oversight, but how is this accomplished? Sponsors are outsourcing more clinical research processes, and they need to have both the team and processes in place to bring on vendors and manage them to be compliant and ensure a cohesive team approach.This presentation will instruct the participant on how to ensure the correct vendor for their organization and clinical study. The process starts with a cohesive team for the sponsor to define vendor specifications, internal and external planning, pre-selection, evaluating, negotiation, contracting and selection.
Areas Covered in the Webinar:
The webinar will begin with a regulatory overview of sponsor responsibilities This will be followed by explanation on how to choose the right vendor. Finally, Best Practices for creating, implementing and maintaining tools to ensure the correct vendor is chosen for the sponsor requirements.What do the Regulations mean?
Vendor oversight - Where do you start?
- Vendor management as a team approach
- Defining requirements
- Quality insight and input
- Pre-Qualification of a vendor
- Use of Tools and Processes
- Managing vendor performance
- Free Materials:
- Reference documents
- Rule documents or guidance
- Checklist
- Articles
Who Will Benefit:
- CEO
- Contract VPs
- Quality VPs
- IT VPs
- Contract personnel
- Regulatory Affairs Professionals
- Quality Mangers
- GXP
- Consultants
Speaker
Pam Dellea GiltnerCourse Provider
Pam Dellea Giltner,