Building a Vendor Qualification Program for FDA Regulated Industries -
FDA Regulation / Compliance Training Seminar
By: Jonathan M. Lewis, Principal, Advanced Biomedical Consulting (ABC), LLC
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.
This course on vendor qualification program for FDA regulated industries will:
Building a Vendor Qualification Program for FDA Regulated Industries Course Outline:
- 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.
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)
Understanding the Basics of Quality Systems (45 Minutes)
Quality System and Qualification Terminology
The Components of a Sustainable Vendor Qualification Program (30 Minutes)
Vendor Type Classifications
Vendor Information Files
Approved Vendor List
Standard Operating Procedures (SOPs)
Other Programs that Feed the Vendor Qualification Program (1 Hour)
The Question Phase—What a Potential Vendor Needs to Supply (1.5 Hours)
Documentation of Requirements
Understanding and Commitment by Internal Parties
Understanding Phase—How Vendors Meet the Requirements (1.5 Hours)
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
Evaluation Phase—Determining the Best Potential Vendor (1.5 Hours)
Requirements for Entering the Evaluation Phase
Purpose of the Evaluation
Format of the Evaluation
Using Rating Systems
End Result of the Evaluation Phase
Day 1 Closing Comments and Questions (30 Minutes)
DAY TWO (8:30 AM – 1:00 PM)
Welcome and Day 1 Reinforcement (15 Minutes)
Site Audit Phase—On-Site and Off-Site Verifications (1.5 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
Track Phase—Monitor and Requalify (45 Minutes)
Importance of Continuous Monitoring
How to Requalify a Vendor
Vendor Information File
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
Responding to Audit Findings Associated with Vendor Qualification (45 Minutes)
Conclusion/Wrap Up Session (15 Minutes)