ICH E6 GCP Interactive Workshops

Course2

Course 2 - Supplier/Vendor/Contractor Qualification Program (1 day)

8:00 a.m. – 8:30 a.m.

Registration/Continental Breakfast

8:30 a.m. – 10:00 a.m.

Why Have a Vendor Program?

  • Discuss the need for a vendor qualification program 
  • Review guidance documents and regulations
  • Discuss the different types of vendors an organization may have and how to approach them.
  • Introduce the risk based approach to vendor qualification
    • Primary, secondary, consultants, others (software)
  • Why have a qualified vendor’s list and how to establish one?

10:00 a.m. – 10:15 a.m.

Break

10:15 a.m. – 12:00 p.m.

Review the Framework for a Risk-Based Approach to Selecting and Auditing Your Vendors

  • What about preapproval surveys?  How to develop them and when to use them?
  • How to approach urgent vendor approvals/audits
  • How to approach backup vendors
  • Quality Agreements & supplier agreements
  • How do you qualify consultants? Or do you qualify them?

12:00 p.m. – 1:00 p.m.

Lunch

1:00 p.m. – 2:15 p.m.

Periodic Reassessment of Your Vendors

  • Annual review of vendors by process owner
  • Re-evaluation of vendors by quality
    • Re-auditing onsite or remotely
    • Frequency of re-evaluation of vendors based on risk

2:15 p.m. – 2:30 p.m.

Break

2:30 p.m. – 4:30 p.m.

Challenges with Vendors and Solutions

  • What do you do when you vendor fails to deliver?
  • What if you do not have a qualified back up vendor and your primary vendor is having problems?
  • What if top management prefers one vendor over another?
  • How do you keep backup vendors approved if you do not send them work?
  • What if a vendor audit report has multiple major findings?
  • Review case studies

 

 

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