Course "Building a Vendor Qualification Program for FDA Regulated Industries" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

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.

Seminar Fee Includes:

AM-PM Tea/Coffee
Seminar Material
USB with seminar presentation
Hard copy of presentation
Attendance Certificate
$100 Gift Cert for next seminar

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


DAY ONE (8:30 AM – 4:30 PM) DAY TWO (8:30 AM – 1:00 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)

    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 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 the industry and in 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.

Register Now

Online using Credit card

Get the Invitation
Pre-Register yourself and get the official Invite when venue and dates are announced for this seminar.
Call here to register +1-888-717-2436 or email at

Other Registration Option

By order form / PO#

Payment Mode

By Check -
Pay your check to (payee name) “MetricStream Inc” our parent company and Mail the check to:

ComplianceOnline (MetricStream, Inc),
2479 East Bayshore Road Suite 200
Palo Alto, CA 94303

By Wire -

Register / Pay by Wire Transfer

Please contact us to get details of wire transfer option.

Terms & Conditions to Register for the Seminar/Conference/Event

Your registration for the seminar is subject to following terms and conditions. If you need any clarification before registering for this seminar please call us @ +1-888-717-2436 or email us @

Payment is required 2 days before the date of the conference. We accept American Express, Visa and MasterCard. Make checks payable to MetricStream Inc. (our parent company).

Cancellations and substitutions:
Written cancellations through fax or email (from the person who has registered for this conference) received at least 10 calendar days prior to the start date of the event will receive a refund — less a $200 administration fee. No cancellations will be accepted — nor refunds issued — within 10 calendar days before the start date of the event.

On request by email or fax (before the seminar) a credit for the amount paid minus administration fees ($200) will be transferred to any future ComplianceOnline event and a credit note will be issued.

Substitutions may be made at any time. No-shows will be charged the full amount.

We discourage onsite registrations, however if you wish to register onsite, payment to happen through credit card immediately or check to be submitted onsite. Conference material will be given on the spot if it is available after distributing to other attendees. In case it is not available, we will send the material after the conference is over.

In the event ComplianceOnline cancels the seminar, ComplianceOnline is not responsible for any airfare, hotel, other costs or losses incurred by registrants. Some topics and speakers may be subject to change without notice.

Attendance confirmation and documents to carry to the seminar venue:
After we receive the payment from the registered attendee, an electronic event pass will be sent to the email address associated with the registrant 5 working days before the seminar date. Please bring the pass to the venue of the event.

Conference photograph / video:
By registering and attending ComplianceOnline conference, you agree to have your photographs or videos taken at the conference venue and you do not have any objections to ComplianceOnline using these photos and videos for marketing, archiving or any other conference related activities. You agree to release ComplianceOnline from any kind of claims arising out of copyright or privacy violations.

Media Partners


Media Partner Benefits
  • Logo and company data on the event website.
  • Logo on the conference material distributed during the conference.
  • Media partner’s brochure distributed along with conference material.
  • Logo on all the mailings before and after the event.
  • 10% discount to media partner's subscribers.

Media Partner To Do
  • Banner (min 728x90 or 468x60) on the media partner website.
  • Insertion of the event in the event calendar, both printed and/or online.
  • Announcement article of the conference on the magazine and/or website.
  • Dedicated email blast to media partner’s subscribers.
  • Article on the magazine and/or website after the conference.

Local Attractions

This massive, world-famous theme park includes Magic Kingdom Park, Disney - MGM Studios, Epcot, Disney's Animal Kingdom, Downtown Disney, and more.

Opened in October of 1971. One of the most famous theme parks in the world featuring Cinderella's castle with classic rides like Pirates of the Caribbean, Haunted Mansion, Space Mountain, Country Bear Jamboree, Hall of Presidents, etc. Frontierland, Tomorrowland, Liberty Square, Adventureland, and Fantasyland, Great for families with kids 10 and younger.

Theme studios park features Jaws, T2, Twister, Men In Black, etc. and various back lot sets used in the movies. CityWalk is an entertainment venue with many restaurants, night clubs, retails stores and a great party atmosphere. Movie theatre near the entrance. Also Hard Rock Cafe, Jimmy Buffet's Margaritaville, Emiril's, NASCAR Cafe.

Get close to nature with everything from a coral reef and tropical river swim to an aviary and sting ray lagoon at Discovery Cove, a park that's part sanctuary, part adventure.

Have a splashing good time at one of the country's premier water parks, offering rides for all ages.

Featuring open-air shopping, dining and entertainment, with more than 40 specialty retailers, delicious restaurants, and exciting entertainment.

The Living Bible theme park features a re-creation of ancient Jerusalem, craft shops, performances, food stands, and the Temple of the Great King.

We need below information to serve you better

Best Sellers
You Recently Viewed