Leading Minds Workshop – San Diego May 2019
Leading Minds Workshop – San Diego May 2019

Leading Minds Workshop – San Diego May 2019

Seminars

16 May 2019

May 16 | San Diego USA

Establishing Clinical Supply Good Distribution Practices (GDP) for Temperature Sensitive Products

ELPRO and Biocom are delighted to announce the date of the Leading Minds Workshop on May 16th at the Alexandria Hotel in San Diego.

This half-day workshop (10.30am-2.00pm) is a series of discussion-based sessions for temperature control supply chain and QA life science practitioners.

The storage and transport of temperature sensitive materials and products is an ongoing challenge for biotech companies. Regulations underline strict documentation requirements of your operational and validation processes for your facilities, transport lanes and shipping systems.

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

“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

 

The May 16th workshop theme will be Establishing Clinical Supply Good Distribution Practices (GDP) for Temperature Sensitive Products. We will examine the increasing requirements needed for products as the move through the development and into commercial supply. Such as the need for additional lanes or facilities, sourcing the right shipping systems, and qualifying suppliers – all with possible international scope.

REGISTER HERE

 

WORKSHOP TOPICS

Discussion: Protecting the Quality of Clinical Products Moving Through Stages of Development Toward Commercialization or Acquisition

  • How are you monitoring your clinical supply?
  • Balancing limited data with cost-effective packaging choices
  • What would a large pharma firm look for in terms of quality control before acquisition? How GDP directly impacts reliable Phase II clinical results.
  • Regulatory audit common questions or concerns in late stage trials as operations move toward commercialization

Discussion leader: Bob Seevers, Senior Advisor, Pearl Pathways & Member USP <1079> Packaging and Distribution Committee 

 

Discussion: Best Practices Supplier Qualifications and Auditing of CROs and Clinical Sites

  • Strategies and methods for consistent, ongoing monitoring to ensure GDP compliance
  • Developing key operating parameters
  • Questions and parameters for Quality Agreements

Discussion leader: Denise Valentino, Director Logistics & Global Trade Compliance, Neurocrine BioSciences, Inc.

 

Discussion: Growing with Changing Clinical Supply Chains: Last Mile Quality Control

  • Broken points along the clinical supply chain
  • Clinical sites Quality Control: on-site excursions, missing data and failing processes
  • Ideas for improvement in the last clinical miles to ensure on-time trials and patient safety
  • If you have stability data, are you using it?

Discussion leader: Jeroen van Loo, Key Account Manager, ELPRO  

 

Discussion: Establishing Your Best Practices for Packaging Validation According Global Standards

  • How are companies balancing cost, regulations and social responsibility?
  • Comparing regulations in global markets and regional expectations
  • How can vendors help leverage and set up a growing global network?
  • Comparing approaches to re-conditioning and reclamation testing standards?
  • How can manufacturers be certain vendor pre-qualified packaging is meeting ISTA and other industry standards?
  • How do vendors do their validations and run against multiple standards?

Discussion leader: Kevin Hickman, Manager, Supply Chain Distribution, Gilead Sciences, Inc.

REGISTER HERE 

 

Some impressions of 2018

 

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. https://www.biocom.org/s/

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