How to Make Sure Your Foreign Vendor is FDA Compliant and Stays That Way

Date: December 3, 2024
Duration: 60 Minutes
Time: 12 PM EST

In a 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, and lack of vendor oversight. With increasing globalization of operations, vendors for all aspects of development are involved at all geographic locations. Most discussions for foreign vendor qualification are limited to manufacturing operations while clinical trials, centralized labs, and animal testing facilities have an almost equal probability of being located at a foreign site. It works both ways; sponsors using bad vendors suffer the financial, regulatory and legal consequences, while for vendors with bad history, it is hard to find new business. Hence, just like the sponsor, vendors also need to assure that the client is suitable and will not cause major issues later.

Why should you attend:
This webinar, presenting by a leading quality assurance industry expert will discuss FDA expectations from vendor qualification. Practical issues with foreign vendors will be discussed with specific case studies with vendors from common regions of the world with many vendors. The seminar will highlight key regulatory requirements, dos and don’ts, common areas of concern, and trouble-shooting practices for FDA regulated industry using case studies and examples from the presenter’s vast experience helping companies big and small find vendors world-wide. Similarly the vendor perspective in finding the appropriate client will be discussed. The webinar will provide precise and complete list of measures and checklists to be implemented by FDA-regulated companies to bullet-proof their vendor selection, management and supervision. This seminar will provide sponsor companies with the necessary tools to make an informed decision when qualifying a vendor’s compliance. Conversely, the session will provide vendors with proven techniques to win sponsor business and exceed regulatory and performance expectations.

Areas Covered in the Session:

The top five vendor qualification and vendor mistakes – how parties can avoid them
Key components for the vendor selection process
Factors governing successful vendor-client relationship
Best practices for vendor interactions and the selection process
When to do an on-site audit and when to avoid it
Auditing for GMP, GCP and GLP compliance
Rules for information FDA about selected vendors
Key documentation requirements

Who will benefit:

Regulatory affairs personnel
Quality assurance personnel
Clinical Project Managers
Clinical Trial Professionals
Vice presidents, Directors and Managers
People interested in investing in the FDA-regulated industry

Speaker: Mukesh Kumar

PhD, RAC | CEO, FDAMap

For more info, fill the box below. We will contact you within 24 hrs.

Webinar Fee

Single Registration

$199

Group Registration (5 Persons)

$699

Group Registration (10 Persons)

$1199

Prices are in US Dollars.
The registration fee includes: The live webinar & all related course materials.

Terms & Conditions to register for the Webinar

Your Registration for the workshop is subject to following terms and conditions. If you need any clarification before registering for this webinar please email us at info@fdamap.com

Payment

We accept credit card, debit card, and PayPal.

Cancellations & Substitutions:

Written cancellations through fax or email (from the person who has registered for this conference) received at least 5 business days prior to the start date of the event will receive a refund — less a $30 administration fee. No cancellations will be accepted — nor refunds issued — within 5 business days before the start date of the event. You may however, choose to substitute the webinar for which you are registered with some other webinar in the future.

On request by email or fax (before the seminar) a credit for the amount paid minus administration fees ($30) will be transferred to any future FDA Map event and a credit note will be issued. No-shows will be charged the full amount.

Webinar material will be uploaded on the website 24 hours before the scheduled date of the webinar. In case it is not available on the website due to some technical issues, we will email the material a few hours before the start of the webinar.

In the event FDA Map cancels the webinar, FDA Map will issue a full refund to all the registrants for that webinar. Some topics and speakers may be subject to change without notice.