Selecting and Managing Vendors in Clinical Research

3,000.007,000.00

Product Id : FDB3190
Presenter : Pam Dellea-Giltner
Scheduled On : July 19 2019 1:00 PM (India Time)
Duration : 90 Minutes
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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.

Why You Should 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.

Free Materials:

  • Reference documents
  • Rule documents or guidance
  • Checklist
  • Articles

Areas Covered in the Session :

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
Who Will Benefit:

  • Quality Departments
  • Regulatory Affairs Departments
  • IT Departments
  • CEO’s, CTO’s, VP’s and Contract VP’s
  • Contract Personnel
  • GxP Consultants
Purchase Options

1. Live Session, 2. Recording Access, 3. Live & Recording Combo

Presenter Details

Pam Dellea-Giltner
Pam Dellea-Giltner is CEO and principal auditor of PDG Clinical Consulting LLC. She has over 30 years of experience in all aspects of Clinical Research Operations. Experience includes Quality Assurance/GCPs, Pre-Inspection Readiness/Audit Reponses, Project Management, Phase I-IV, post marketing and epidemiology studies, Study Management, Vendor/CRO Set up and management.
She has held positions in both pharmaceutical and CRO companies including GCP Auditor, Project Manager, Clinical Research Associate, and Trial Manager.
Currently she is Chairman of the ACRP CCRA Examination Committee and has been a certified CCRA since 2009.