25 Aug 2018
Southern California’s Life Science community is a leader in novel drug discovery, genomics research and extensive clinical trial research. With a long history of innovation and trail already ablaze with next generation therapeutics, diagnostics and biologics, 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 challenging, even more so when distributing high-value 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.
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.
• Personalized medicines home delivery challenges in packaging design and compliant temperature monitoring
• Strategic logistics collaborations in clinical supply chains and commercial bulk supply; including examining importance of CMO, CRO Quality Agreements and transparent communications
• How to use stability data in the cold chain and understanding what regulatory compliant approaches are for ‘allowable excursions’ and shipping to label claim
• Controlled Room Temperature (CRT) shipping: Bringing all partners (internal and external), warehouses, and shipping systems into compliance for a cost-effective supply chain
About Leading Minds Seminars
Leading Minds Seminars bring together serious-minded practitioners to solve very real, very challenging operational hurdles in the pharmaceutical cold chain. Learning from your peers in other pharma companies, ensures you’re on track, implementing the right, most cost-effective best practices.
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.
Collaborative and community-based learning at its best.
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:
• Freight forwarders, 3PLs, specialty couriers
10996 Torreyana Road San
Diego, CA 92121
***Please note: This event is only open to industry members of Biocom and 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, please contact Angela Wieszchowski at angelaw[at]biocom.org.
- ELPRO Leading Minds Network Members (Industry): $0 (Use special discount code “ELPRO”)
- Biocom Members (Industry): $0
- Biocom Non-Members (Industry): $250
(Refund before Friday, September 07, 2018; Refunds will no longer be accepted after Wednesday, September 05, 2018)
For any exhibition enquires, please contact Angela Wieszchowski at Biocom: email@example.com
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. https://www.biocom.org/s/
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