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Webinars >>Vendor Validation
FDA Compliant Warehouse and Distribution Practices

A warehouse can simply be defined as a planned space usually a large commercial building for handling and storage of goods. Distribution on the other hand is the process of making the goods available for consumption by business users and final consumers. Both warehousing and distribution practices are critical components of the supply chain management. Any non-compliance or disruption in either can immediate and long-term adverse impacts on the bottom-line or even existence of a company. Hence, maintaining safe and GMP compliant warehouse and distribution facilities and practices are critical for all manufacturers. While there are a few general guidelines from the FDA regarding supply chain management, FDA’s expectations from receipt, warehousing, and distribution practices are widely misunderstood by manufacturers leading to frequent findings of non-compliance in these aspects during FDA audits. 
​Why you should attend?

This webinar will focus on all current regulations and FDA Guidance Documents related to supply chain management starting from acceptable practices for receipt of materials, control of intermediates, finished product storage and handling, release of materials, short-term and long-term storage, shipping practices, and recall management. Challenges and opportunities for FDA-compliance verification of warehousing and distribution will be discussed with examples from real world scenarios. Best practices for the control of flow and maintenance of goods will be discussed. This webinar will provide warehouse operators and third-party service providers alike, a measure to evaluate current practices for compliance with Good Storage/Warehouse Practices (GSP) and Good Distribution Practices (GDP) for drug and biotechnology products.
Areas Covered in the Session:
  • Principles for Material Control in GMP Facilities
  • Basic expectations from GSP and GDP
  • Responsibility for Traceability and accountability
  • Supply Chain Flow Charts
  • Vendor validation for shipping and distribution
  • Product recall management
  • ​
Who will benefit:
  • Personnel working in packaging, labeling, storage, and distribution
  • Quality Control and Assurance
  • Manufacturing and Packaging
  • Managers, CEOs & Directors
  • Warehouse Managers
Date: September 30, 2022
​Duration: ​60 Minutes
​
Time: 12 PM EST
Register Online

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

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For additional information on the workshop agenda and logistics, please call 410-501-5777 or email: info@fdamap.com

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