Webinars >>Clinical Trial
Managing Supplies in Your Clinical Trial: FDA Compliant Supply Chain Management
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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:
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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
Date: April 15, 2020
​Duration: 60 Minutes
​Time: 12PM EST

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