Understanding the Drug Supply Chain Security Act (DSCSA)

Instructor: Eleonora Babayants
Product ID: 706499
Training Level: Intermediate to Advanced
  • Duration: 60 Min
As the Drug Supply Chain Security Act (DSCSA) key requirements continue to take effect, FDA has begun its enforcement. Any company involved in the sale or purchase of prescription drugs has to comply with this act. This webinar will describe the key requirements of this act, reporting requirements, and how to comply with this act.
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Why Should You Attend:

The DSCSA establishes product tracing, licensure, reporting, and other requirements for certain trading partners in the drug supply chain. Any company involved in the sale or purchase of prescription drugs has to comply with Drug Supply Chain Security Act (DSCSA).

FDA intends that this new guidance will assist pharmaceutical industry in understanding the verification systems requirements and provide recommendations on what those systems should include.

Learn the key requirements of this act, reporting licensure, and how to comply with this act. Gain the right tactics to avoid problems with DSCSA implementation.

As the DSCSA key requirements continue to take effect, FDA has begun its enforcement. Any company involved in the sale or purchase of prescription drugs has to comply with this act. The DSCSA outlines steps to build an electronic, interoperable system to identify and trace certain prescription drugs as they are distributed in the United States.

According to this act, FDA established national licensure standards for wholesale distributors and third-party logistics providers, and requires these entities report licensure and other information to FDA annually.

Areas Covered in the Webinar:

  • Key requirements of the DSCSA
  • Strategies to comply with DSCSA
  • Reporting licensure under this act
  • How to handle suspect and illegitimate products
  • Authorized trading partners
  • How to exchange product tracing information
  • How FDA is enforcing DSCSA

Who Will Benefit:

  • Quality Assurance
  • Regulatory Affairs Personnel
  • Compliance Personnel
  • Medical Affairs
  • Supply Chain Managers

From the Pharmaceuticals Industry

Free Materials:

  • Presentation
Instructor Profile:
Eleonora Babayants

Eleonora Babayants
Founder and President, Galaxy Consulting

Galaxy Consulting Founder and President Eleonora Babayants has many years of GxP/GMP hands-on experience in regulated industries. She worked with quality assurance and compliance officers to develop and execute compliance strategies and programs. She participated in the implementation of compliance requirements.

Her many years’ experience includes regulatory compliance, internal and external auditing, change management, documentation and records management, document control, electronic document management systems, information governance, IT systems management and validation.

Eleonora’s past work includes development and implementation of regulatory compliance policies, processes, and procedures, leading implementation and administration of document control and document management systems in full compliance with regulatory requirements, designing and implementing electronic documents workflows, leading enterprise content management initiatives, enabling enterprise search, improving systems information architecture, creating and implementing users’ training programs.

Eleonora ensured document management systems compliance with regulatory requirements. She collaborated with users to develop positive and productive approaches to regulatory compliance, coordinated, prepared, and participated in internal and external audits including FDA audits.

Eleonora’s experience spans multiple industries including biomedical, pharmaceutical, and medical devices companies.

Follow us :
Raw Material Requirements (Health Canada/USP/EP) in a cGMP Environment - Issues and Solutions
Change Control Best Practices - Avoiding Unintended Consequences of Changes

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