New FDA Requirements for Healthcare

 

Are you ready for improved recall processes and the required data management for post-market surveillance and adverse event reporting? Join us for an overview of the regulations and their impact on product data for patient safety.

The discussion will include:

  • Overview of Food and Drug Administration Safety and Innovation Act (FDASIA) and its resulting explanation of Unique Device Identifiers (UDI) and incorporation into Proposed Meaningful Use
  • Overview of Drug Supply Chain Security Act (DSCSA)
  • Live Q & A session

 

About the Presenters:

Jean Sargent 105x145Jean Sargent is the Vice President of Healthcare Strategy and Implementation at USDM Life Sciences. She has over 36 years of experience in central service/materials and supply chain management. Jean has been actively involved with education over the last fifteen years as a speaker, educator, and writer/editor. Jean actively participates in many activities related to the healthcare supply chain to improve upon use of industry standards such as UDI to improve patient safety.

 

 

Chris Chandler 105x145Chris Chandler is the Vice President of Healthcare Services and Solutions. She focuses on helping healthcare providers, hospitals and pharmacies develop supply chain solutions for medical devices and pharmaceuticals that meet regulatory compliance requirements. Chris and her team specialize in Unique Device Identification (UDI) and Drug Supply Chain Security Act (DSCSA) regulations. Chris ensures not only that our clients comply with government regulations, but are able to ensure quality products and reduce operational costs.

 

 

 

Register Now

Testimonials

  • Clintrak - Jeffrey D. Coffin
    I have had the great pleasure to work with Bob for 5 years in his position of VP of Quality at Fisher Packaging Services while I acted as Director of Quality services at a sister…
See all Testimonials