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

Event Details

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

Time: March 20, 2014 at 8:30am to March 21, 2014 at 1pm
Location: Courtyard Marriott Boston - Cambridge
Street: 777 Memorial Drive
City/Town: Cambridge
Website or Map: http://www.complianceonline.c…
Phone: +1-650-620-3915
Event Type: biotechnology, and, pharmaceutical
Organized By: ComplianceOnline
Latest Activity: Mar 6, 2014

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Event Description

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

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