Webinar: GxP, Supply Chain Quality and Auditing your Transport Firm
Sponsored by: World Courier
Focused on:
Date: 12th June
Days old: 4621
Time: 3PM London / 10AM New York
Assuring Effective Clinical Trial Quality through Supplier ‘Best Practice’ and Oversight
Virtually every international regulatory agency now calls for GxP compliance throughout the entire length of the clinical supply chain. Penalties for non-compliance are severe, weighing heavily on the sponsor in the form of risk to public health, regulatory warnings, fines, declined new drug applications, and loss of partnerships and professional reputation.
In this compelling webinar, Dr. Rüdiger Lomb, World Courier’s Global Director for Quality & Technical Compliance, will discuss the realities of ensuring cold chain regulatory compliance from origin to destination − particularly in emerging markets and severe climates − as well as the need to partner with a reliable GxP-compliant logistics supplier to guarantee provision of compliant services and data, to minimise temperature deviations, related product loss and data review by the clinical team.
In her presentation, colleague Sue Lee, World Courier’s Regional Quality Manager (U.K., Ireland, Middle East & Africa) will walk the audience step-by-step through the auditing process for transport companies, providing tips and suggestions for ensuring all compliance criteria are met.
Be sure to register for this invaluable webinar presented by the industry’s leading transport and logistics provider for global clinical trials.
Presented by
Dr. Rüdiger Lomb,
Global Director for Quality & Technical Compliance, World Courier
Dr. Rüdiger Lomb is Global Director, Quality & Technical Compliance for the World Courier group of companies. Since joining World Courier in 2008, Dr. Lomb has brought his considerable technical expertise to bear on shaping and refining the company’s Quality Assurance program. Dr. Lomb was formerly Group Head and Director of the Global Logistics Clinical Supplies Division for Bayer Schering Pharma AG in Germany where he was responsible for the auditing and qualification of depot and transportation service providers. Dr. Lomb is a licensed pharmacist and holds a Ph.D. in pharmaceutical bio-chemistry.
Sue Lee,
Regional Quality Manager (U.K., Ireland, Middle East & Africa), World Courier
Sue has a background in Microbiology and has worked for World Courier for more than 20 years. She is part of a global team working on development of new and innovative systems for packaging, freezer facilities, training programs, and SOPs. She is the Regional Quality Co-ordinator for UK, Eire, Middle East and Africa.
Download Slides
Please login to download the slidesKey Learning Objectives
- Strengthen the clinical supply chain by partnering with legitimate GxP-compliant logistics providers.
- Identify compliant suppliers and analyse the strengths and weaknesses of your transport network.
- Understand the audit process for transport companies and know what to focus on.
- Identify key audit criteria to ensure operational conformity and optimum results.
Audience
- CEO/President/Chairman/Executive Director
- Pharmaceutical Company Personnel including Medical Directors
- Project Managers
- CRAs
- Investigators
- Study Coordinators
- Logistics Managers
- Quality Assurance Managers
- Clinical Research Personnel working for Research Laboratories
- CROs and Biotechnology Firms.