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The purpose of this webinar is to discuss licensing and registrations for prescription drug distribution. This webinar will provide education for companies to distribute medicinal products within the U.S. at the federal and state-level. The webinar does not include DEA Controlled Substances (e.g., CI – V).


Due to the extremely complex spider-web regulatory environment one should attend this training to learn how to lower company risk by avoiding product adulteration, avoiding disciplinary action, enforcing product efficacy and quality management systems via federal and state statutory regulations. This’ll provide a very broad understanding of the rules and regulations for distributing medical products to the market. From a sales prospective, products that conform to the statutory framework ensure products are safe and effective for all of us, our families and the Companies bottom-line.


The key learning objectives are:

  • Federal (e.g., FDA) and state licensing and registration requirements
  • Closed-loop distribution model
  • Last mile delivery
  • Federal FDA Drug Quality and Security Act (DQSA) and Title II of DQSA, the Drug Supply Chain Security Act (DSCSA) - Recordkeeping (e.g., FDA Product Tracing (e.g., T3)
  • Quality Management Systems (QMS)
  • How to budget
  • Facility layout and structure
  • Site inspections/audits
  • Registered Agent and Secretary of State Foreign Qualification registrations
  • Product registrations (US and PR)
  • Fingerprints, background checks, etc. 


Types of state licenses and accreditations:

  • Wholesale Distributor
  • Rx Broker
  • Third-Party Logistics Provider (3PL)
  • OTC Distribution
  • Veterinarian
  • Reverse Distributor 
  • Medical Gas
  • VAWD  
  • Medical Devices
  • Bonds
  • CDR (Certified Designated Representative) requirements
  • Freight Forwarder (Export)
  • Private Label Distribution (“PLD”) (will be discussed in detail next webinar)
     


  • Life Science professionals.
  • Supply-Chain Managers.
  • Compliance Officers.
  • Regulatory Affairs.
  • Distribution Operations.
  • ManagersPharmacists etc.


MedEden, LLC is presenting the webinar.

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