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How to Manage Your Vendors in Clinical Research

 
 

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 regul

How to Manage Your Vendor in Clinical Research

 

  • One Dial-in One Attendee

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    USD 249
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  • Group-Max 10 Attendees or Location

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    USD 629
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  • 1x Person - Unlimited viewing for 6 Months

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    USD 299
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  • One CD or USB is for usage in one location only

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    USD 399
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  • LIVE + RECORDED VERSION

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    USD 429
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  • LIVE + TRAINING CD or USB

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    USD 529
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About The Event

How to Manage Your Vendors in Clinical Research

 
 
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 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

Instructor Profile:

Pam Dellea Giltner

Pam Dellea Giltner
CCEO, PDG Clinical Consulting LLC

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.

 

Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

 

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