Webinars >>Vendor Validation
FDA Compliant Vendor Validation Programs

​The sponsor is ultimately responsible to the FDA for all services provided by a vendor, so it is critical that vendors be appropriately validated for capability and compliance for the contracted tasks. The need for vendor validation is agnostic to whether you have a short-term or long-term projects, exploratory or pivotal tasks, small or large corporate vendors, or local or foreign vendors. Similarly, vendors need to be aware of the FDA requirements and client expectations for allocating appropriate resources and invoicing for services.
 
In this webinar, we would discuss various aspects of vendor operations, common issues often overlooked, simplified solutions and oversight of vendors by sponsors. Lifecycle management and dynamic contracts will be discussed. This webinar will help attendees learn the best ways to create an ongoing vendor qualification and validation program. It will discuss common issues to avoid when it comes to vendor selection and management.
​Why you should attend?

In an FDA-regulated industry, sponsor companies are only as compliant as their vendors. Any violations at the vendor are liabilities for the sponsoring company. The sponsor is held responsible for its poor vendor selection, vendor non-compliance, and lack of vendor oversight. Sponsors using bad vendors suffer the financial, regulatory, and legal consequences. Similarly for the vendors it is equally critical to have transparent relations with the client.
 
You need to attend this webinar, if:
  • You have wasted time on qualifying vendors that you know cannot or will not meet your requirements.
  • Your approach to vendor qualification and vendor audits has led to internal CAPAs, customer audit items, or 483 observations.
  • You are unsure whether an onsite vendor audit is necessary as per the FDA
 
This webinar is designed to help the companies of any FDA regulated products to build or develop a sustainable vendor qualification program.
Areas Covered in the Session:
  • FDA requirements for your Vendor
  • Aspects of Vendor Qualification
  • Vendor Qualifications checklist and forms
  • Best Practices for Vendor-Client Relationship
  • Vendor Audits
  • How to change Vendors
  • Quality Agreements​​
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:
  • QA professionals
  • Contracting professionals
  • Regulatory specialists
  • Legal Departments
  • Compliance Officers
  • Purchasing Managers
  • QC Managers
  • QA Managers
  • Quality and Sales Department Staff
  • Compliance Consultants
  • Senior Management
Date: July 14, 2023​Duration: ​60 Minutes
​Time: 12 PM EST

Speaker: Mukesh Kumar
​PhD, RAC | Brij Strategic Consultations, USA

    For more info, fill the box below. We will contact you within 24 hrs.
For additional information on the workshop agenda and logistics, please call 410-501-5777 or email: info@fdamap.com