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

By: Jonathan M. Lewis, Founding Partner, Reliant FDA Experts™…a Division of Advanced Biomedical Consulting, LLC
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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

Course Outline:

Day One (8:30 AM - 4:30 PM)
Registration Process: 8:30 AM – 9:00 AM
Session Start Time: 9:00 AM

Welcome and Introductions (15 Minutes)

  1. Understanding the Basics of Quality Systems (45 Minutes)
    • Regulatory References
    • Quality System and Qualification Terminology
  2. The Components of a Sustainable Vendor Qualification Program (30 Minutes)
    • Vendor Requirements
    • Vendor Type Classifications
    • Audit Forms/Checklists
    • Vendor Information Files
    • Approved Vendor List
    • Requalification Schedule
    • Standard Operating Procedures (SOPs)
  3. Other Programs that Feed the Vendor Qualification Program (1 Hour)
    • Change Control
    • Complaint Handling
    • CAPAs
    • Deviation Management
    • Sales
  4. The Question Phase—What a Potential Vendor Needs to Supply (1 Hour)
    • Vendor Requirements
    • Budget Consideration
    • Documentation of Requirements
    • Understanding and Commitment by Internal Parties
  5. Understanding Phase—How Vendors Meet the Requirements (1 Hour)
    • Initial Contact with Potential Vendors
    • How to Supply Vendor with Company Requirements
    • Contents of a Vendor Package
    • Obtaining Multiple Vendor Packages
    • How to Assess Packages for Adequacy and Completeness
  6. Evaluation Phase—Determining the Best Potential Vendor (1 Hour)
    • Requirements for Entering the Evaluation Phase
    • Purpose of the Evaluation
    • Format of the Evaluation
    • Using Rating Systems
    • End Result of the Evaluation Phase
  7. Site Audit Phase—On-Site and Off-Site Verifications (1 Hour)
    • Classification of Vendors
    • On-Site vs. Off-Site Audits
    • On-Site Verification Form
    • Off-Site Audit Checklist
    • How to Score the Audit
    • Options for Rejected Vendors
  8. Track Phase—Monitor and Requalify (30 Minutes)
    • Importance of Continuous Monitoring
    • Requalification Schedule
    • How to Requalify a Vendor
    • Vendor Information File
  9. Time and Costs Associated with Vendor Qualification (30 Minutes)
    • Estimating Time Associated with Each Vendor
    • Hidden Costs of Vendor Qualification
    • Estimating Costs of Using Consultants
  10. Responding to Audit Findings Associated with Vendor Qualification (30 Minutes)
  11. Day 1 Closing Comments and Questions (30 Minutes)
Day Two (8:30 AM - 1:00 PM)

    Welcome and Day 1 Reinforcement (15 Minutes)

    1. Site Audit Phase—On-Site and Off-Site Verifications (1 Hour)
    2. Practical Application # 1 –Qualifying a Services Vendor (1 Hour)
    3. Practical Application # 2 –Qualifying a Raw Material Vendor (1 Hour)
    4. Practical Application # 3 –Vendor Qualification 483 Response (1 Hour)
    5. Closing Comments (15 Minutes)
    6. Individual/Open Q&A Session (30 Minutes)

Meet Your Instructor

Jonathan Lewis
Jonathan M. Lewis,
Founding Partner, Reliant FDA Experts™…a Division of Advanced Biomedical Consulting, LLC

Jonathan M. Lewis, founding partner, Reliant FDA Experts™…a Division of Advanced Biomedical Consulting, LLC, has over nineteen years’ experience in the areas of quality control/quality assurance (QA/QC), regulatory affairs, manufacturing, validation, project management, and executive management in both industry and consulting roles. Mr. Lewis has experience in the medical device, diagnostic, biopharmaceutical, pharmaceutical, cosmetic, nutritional supplement, food, and animal food industries.

Prior to founding Reliant FDA Experts™, Mr. Lewis worked for KMI/PAREXEL, a regulatory compliance and validation consulting firm, in increasing roles of responsibility from an entry-level validation engineer to the associate director of consulting. He has worked at RPScherer (Cardinal Health), a contract and proprietary solid oral dose pharmaceutical manufacturing facility, as the QC/validation manager. In addition, he has worked at Telectronics Pacing Systems, a medical device manufacturer, as a sterility assurance laboratory technician.

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