Building a Vendor Qualification Program for FDA Regulated Industries: One and Half Day In-Person Seminar

Course Description:

If you are looking for the answer to the following questions, you will certainly benefit from attending this seminar on building a vendor qualification program:

• Have you wasted hours, days, and weeks on qualifying vendors that you know cannot or will not meet your requirements?
• Has your approach to vendor qualification and vendor audits left you with internal CAPAs, customer audit items, or 483 observations?
• Have you wondered whether an onsite vendor audit is necessary in the eyes of FDA?

Well, the answers to these and many more questions are now available in a simple to understand, yet detailed training session designed to help manufacturers of FDA regulated products build (or rebuild) a sustainable vendor qualification program.

Learning Objectives:

This course on vendor qualification program for FDA regulated industries will:

• Define a sustainable structure for a vendor qualification program.
• Explain how change control and other quality programs feed into the vendor qualification program.
• Offer usable audit forms/checklists and other vendor qualification program document templates.
• Explain how to:
  • Determine the best potential vendor and what a potential vendor needs to supply before qualification.
  • Initially identify vendors that meet your requirements prior to qualification.
  • Perform on-site and off-site verifications.
  • Monitor and re-qualify vendors.
  • Estimate costs and time associated with vendor qualification.
  • Respond to customer and regulatory audit observations associated with vendor qualification.
• Discuss common pitfalls to avoid when qualifying vendors.

Who Will Benefit:

This course will provide valuable assistance and guidance to all FDA regulated companies for building sustainable vendor qualification program. The following job titles/ positions will benefit from attending this seminar:

• Internal Auditors
• Regulators
• Legal Departments
• Compliance Officers
• Purchasing Managers
• QC Managers
• QA Managers
• Quality and Sales Department Staff
• Compliance Consultants
• Senior Management