Managing Supplies in Your Clinical Trial: FDA Compliant Supply Chain Management

Date: December 16, 2024
Duration: 60 Minutes
Time: 12 PM EST

Clinical trials occasionally deal with avoidable delays due to supply chain issues. Common issues are managing expiration of the investigational drugs at sites, assuring adequate handling, maintaining accountability, shipping delays, demand management and supply interruptions. The issues get further complicated for adaptive trials, multi-site multi-country trials, products with short shelf-lives, and products in limited supplies. Supply chain issues not only delay the trials but also add to the cost and logistical challenges. Almost all supply chain issues are predictable and can be addressed with planning and training.
 

Areas Covered in the Session:

  • Three areas of supply chain control
  • Nine step checklist for supply management
  • Best practices for moving, replacing, updating and securing supply chain
  • Common issues raised during FDA audits
  • Quality agreements with your suppliers
  • What does FDA expect from a sponsor regarding supply chain control
  • Managing supplies at local, regional, and foreign sites
Why should you attend:
This webinar, presented by a leading expert on clinical trials, will discuss best practices for managing the clinical trial supply chain issues using examples and case studies. Three key areas of concerns and nine major issues related to supply chain will be discussed. Common questions such as the best way to prepare the site team, documentation review, SOPs needed, off-the shelf and custom software for supply management, best way to manage supply flow, electronic and paper systems, and many more will be discussed. The seminar will discuss critical areas to focus resources, important things to verify, best practices to maintain adequate investigational material supply, audits of supply chain, and many other practical insights. The webinar will provide precise and complete checklist of measures to help you evaluate your trial practices. The presenter will use case studies from his vast experience to highlight common errors and potential solutions.
 

Who will benefit:

  • Clinical Project managers
  • Manufacturing and supply chain operations
  • Regulatory affairs personnel
  • Quality assurance personnel
  • Vice presidents, Directors and Managers
  • People interested in investing in the FDA-regulated industry

Speaker: Mukesh Kumar

​PhD, RAC | CEO, FDAMap

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Webinar Fee

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

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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.

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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.

For any information on the training agenda and logistics, please call +1 410-501-5777 or email: info@fdamap.com