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

When:

May 16, 2019 10:30 amMay 16, 2019 2:00 pm

Where:

The Alexandria at Torrey Pines
10996 Torreyana Road
San Diego, CA 92121

Registration Closed

Join Biocom and ELPRO at our half-day workshop filled with discussion based sessions geared toward temperature control supply chain and QA life science practioners.

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.

This workshop will be themed Considerations for Clinical GDP Operations. 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.

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, 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.


Who should attend:
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.
  • Supply Chain, Logistics
  • Quality Control/Quality Assurance
  • Clinical Supply
  • Packaging Engineering
  • Cold Chain
  • Commercial operations or warehousing
  • Regulatory Affairs
Also, biopharma partners:
  • CROs
  • CMOs
  • Freight forwarders, 3PLs, specialty couriers
  • Packaging suppliers
**Mark your calendar for September 10th, 2019 for the full-day Leading Minds Seminar, lunch and evening reception. Save the date and register HERE.

About ELPRO (for Biocom website)
ELPRO has been a partner to biopharma companies for three decades developing compliant data monitoring systems for facilities and products in-transit. ELPRO’s data loggers and software protect your biotech assets from lab to supply chain: growing and adapting as your products move through trials and into market. ECOLOG Monitoring Solutions for Rooms and Equipment allows great flexibility to access your facility remotely via internet browser to see temperature, CO2, RH, Pressure differential or any 4-20mA signal. LIBERO PDF multi-alarm data loggers monitor shipments to control a wide-range of biotech applications (-200C…+200C) including clinical trial kits, ultra-low shipments and APIs. Ask us about new developments in real-time monitoring and wireless monitoring. ELPRO’s US headquarters is in Marietta, Ohio since 2003 with a full technical support staff; and offices in San Diego and San Francisco.
www.elpro.com

Price of Admission

Biocom Member (Industry)

Today’s Price: 20

Important Dates

Amount

Registration before

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Registration cost

20

Refund before 2019-05-13

0

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Non-Member (Industry Only)

Today’s Price: 40

Important Dates

Amount

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Registration cost

40

Refund before 2019-04-10

40

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  • About ELPRO
    ELPRO, headquartered in Switzerland, has been a global partner to biopharma companies for three decades developing com­pliant data monitoring systems for facilities and products in-transit. ELPRO’s data loggers and software protect biotech assets from laboratories to supply chain: growing and adap­ting as products move through trials and into market. ECOLOG Monitoring Solutions for Rooms and Equipment allows great flexibility to access your facility remotely via internet browser to see temperature, CO2 RH, Pressure differential or any 4-20mA signal. LIBERO PDF multi-alarm data loggers monitor shipments to control a wide-range of biotech applications (-200°C…+200°C) including clinical trial kits, ultra-low shipments and APIs. Ask us about new developments in real-time monitoring and wireless moni­toring. ELPRO’s USA main office is in Marietta, Ohio since 2003 with a full technical support staff; and offices in San Diego and San Francisco.  www.elpro.com
    User-added image
  • Testimonials
    “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
     
  • Event Compliance
    By Registering for this event, you acknowledge and grant permission for Leading Minds Seminar organizers to utilize your image in promotional communications related to this event. Organizers will also use the information on the registration form to send marketing updates or other information that may be of interest to you. We respect your privacy and you may opt-out at any time. 

Registration Closed