Leading Minds Seminar - San Diego September 2019
Leading Minds Seminar - San Diego September 2019

Leading Minds Seminar - San Diego September 2019

Seminars

10 Sep 2019

September 10 | San Diego, CA USA

Temperature Controlled Distribution of Biologics

ELPRO is delighted to announce the second Leading Minds Seminar co-hosted with Biocom for September 10th 2019 in San Diego.

Southern California’s Life Science community is a leader in novel drug discovery, genomics research and extensive clinical trial research. But, what level of consideration and investment is being allocated to the protection of in-process, clinical, active ingredient and finished good during distribution?

The distribution environment is a whole new ball game, and often not fully considered. These oversights can lead to costly mistakes during the transport and storage of high-value, or irreplaceable, temperature-sensitive products. To preserve the safety and efficacy of these products through each stage of the distribution process, they must be adequately and compliantly protected against thermal and physical stress.

Register today

*Please enter the code "ELPROGuest" when registering.

The Seminar

This one-day seminar will discuss the many challenges facing Life Science organizations when distributing temperature sensitive products including types of stability testing; storing and shipping challenges of ultra-low temperature products, selecting the solution that is right for your product and its distribution environment; temperature data monitoring and management; quality agreements with partners; using multi-modal transport; clinical trial site quality control; and of course – how to best meet regulatory requirements with the resources you have.

Program

Speakers include:

  • Denise Valentino, Director, Global Trade Compliance & Logistics, Neurocrine
  • Kevin Hickman, Senior Manager, Supply Chain Distribution, Gilead Sciences, Inc.
  • Bob Seevers, Senior Advisor, Pearl Pathways & Member, USP <1079> Packaging and Distribution Committee
  • Heather Lane, Senior Supply Chain Specialist, HeronTx
  • Laurie Rockwell, Global Account Manager, ELPRO

Topics include:

  • Knowing the ins/outs of import/export: Follow the rules while saving cost
  • Preparing for commercialization: What data will you put in the BLA?
  • GDP regulations updates across the globe
  • Biopharma and partners: Deeper dive into specific SOPs and contingencies
  • Qualification of shippers or thermal protection systems
  • Using temperature data for quality control and compliance
  • Quality and compliance GxP requirements for facilities

Download Agenda

“This was a highly informative event and I enjoyed meeting other colleagues and experts in my field. I also liked being able to find a few new vendors and discussing some issues with the shipping companies’ experts.”
Brendon Dalsted (Bionano Genomics)

“Interactive format & excellent discussions with peers. A must attend event.”
Frank Toussaint (Biolog Europe)

Unique FUELS Format

Leading Minds Seminars are unique in format and intent: we call it FUELS. Experience sharing and problem solving are at the core of our seminars. Our Seminar programs programs are 65% discussion based. Step in, sit down, benchmark with other practitioners. Fusion of Useful Experiences in Logistics and Storage Collaborative and community-based learning at its best.

Attendees

All Life Science, Biologics, Pharma, and Medical Device practitioners who are faced with the challenges of preserving the safety and efficacy of their organization’s temperature-sensitive products are welcome to attend.

Job titles most likely to benefit in attending are:

  • Supply Chain, Logistics
  • Packaging Engineering
  • Cold Chain
  • Commercial operations or warehousing
  • Quality Control/Quality Assurance
  • Clinical Supply
  • Regulatory Affairs

Also, manufacturer’s partners:

  • CROs
  • CMOs
  • Freight forwarders
  • 3PLs, specialty couriers

Venue

THE ALEXANDRIA
10996 Torreyana Road
San Diego, CA 92121

*Please note, there are no bedroom accommodations at the Alexandria.

Registration Information

This event is only open to industry members of Biocom and the Leading Minds Network, unless sponsoring or exhibiting at the event. This event is closed to any service provider company (member or non-member). A service provider is a company that does not directly work with a substance that needs approval by the FDA and/or does business-to-business sales. They provide a service to the biotechnology and pharmaceutical industry and includes, but is not limited to, law firms, banks, laboratory equipment suppliers, consulting firms, or IT services. Biocom has the right to cancel and refund your registration, should the system allow you to register by mistake. If you are unsure about your status, or to inquire about sponsorship, please contact Angela Wieszchowski.

Register here

*Please enter the code "ELPROGuest" when registering.

Seminar hosted by

 

 

For over 30 years, ELPRO is widely recognized as the global knowledge leader in innovative, Swiss engineered environmental monitoring solutions and data loggers for pharma, healthcare and life science. ELPRO partners with clients to develop solutions that integrate ELPROs high-quality measurement components into their business processes. Clients include biotechs, diagnostic manufacturers, and the top 20 pharma companies. As the inventor of the LIBERO PDF Logger, ELPRO solutions have the lowest total cost of ownership and assist pharmaceutical and healthcare companies around the world preserve and manage stability budgets and simplify their cold chain by reducing manual work, resulting in quicker release times.

 

 

 

Biocom is the largest, most experienced leader and advocate for California’s life science sector. We work on behalf of more than 1000 members to drive public policy, build an enviable network of industry leaders, create access to capital, introduce cutting-edge STEM education programs, and create robust value-driven purchasing programs.

 

 

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