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Building a Vendor Qualification Program for FDA Regulated Industries

This webinar will teach attendees best practices for building a sustainable vendor qualification program for FDA regulated industries. It will discuss common pitfalls to avoid when qualifying vendors.

$999.00
Introducing
Purchase using Webinar All-Access Pass
One User Unlimited access to all recorded webinars for 6 Months

Recorded Version Only

(PPT + Recorded Streaming Link)

$249.00
1x Person - Unlimited viewing for 6 Months (For multiple locations contact Customer Care)
rec Recorded Link and Ref. material will be available in My Account Section

Download File Only

(PPT + Recorded Training File)

$349.00
Downloadable file is for usage in one location only.
(For multiple locations contact Customer Care)
Downloadable link along with the materials will be emailed within 2 business days
Customer Care

Fax: +1-650-362-2367

Email: customercare@fdatrainingalert.com

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Why Should You Attend:

If you are looking for the answer to the following questions, you will certainly benefit from attending this webinar 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 the 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.

Areas Covered in the Webinar:
  • Structure for a sustainable vendor qualification program
  • How change control and other quality programs feed into the vendor qualification program
  • Audit forms/checklists and other vendor qualification program documents
  • How to determine the best potential vendor
  • What a potential vendor needs to supply before qualification
  • How to initially identify vendors that meet your requirements prior to qualification
  • On-site and off-site verifications
  • Monitoring and re-qualification of vendors
  • How to estimate costs and time associated with vendor qualification
  • Responses to customer and regulatory audit observations associated with vendor qualification
  • 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
Instructor Profile:
Jonathan M Lewis Jonathan M Lewis

Principal, Advanced Biomedical Consulting LLC

Jonathan M. Lewis, has over 22 years’ experience in the areas of quality control/quality assurance (QA/QC), manufacturing, regulatory affairs, validation, and project management in both industry and consulting roles. Mr. Lewis has experience in the medical device, diagnostic, biopharmaceutical, pharmaceutical, cosmetic, nutritional supplement, food, and animal feed industries.

Prior to founding Reliant FDA Experts (Reliant) (ABC), LLC, Jonathan worked for KMI/PAREXEL, a regulatory compliance and validation consulting firm, in increasing roles of responsibility from an entry-level Validation Engineer to an 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, in the Sterility Assurance Laboratory.

Topic Background:

While being conscious of the products and services purchased is good practice for consumers and most businesses, it is a regulatory requirement for FDA regulated industries. For these organizations, the decisions where to purchase components, raw materials, manufacturing and testing equipment, and even consulting services, need to be well informed and documented through a vendor qualification program. The results of making poor purchasing decisions can lead to situations that impact product quality, regulatory compliance, company profits, and even the reputation of the company.

Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. FDATrainingAlert would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

If you have any concern about the content of the webinar and not satisfied please contact us at below email or by call mentioning your feedback for resolution of the matter.

We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email customercare@fdatrainingalert.com call +1-888-771-6965 (Toll Free).

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