Technology Transfer (TT) is an increasingly important part of the pharmaceutical industry, with companies expanding the use of third parties for both development and manufacture. There are few formal guidelines around this subject, but regulators expect companies to get it right, for both internal and external transfers. Poorly run transfers can be costly and impact product quality, whereas well-run transfers bring business bene ts and assure product quality.
This event will give participants the tools to help guide them through achieving successful transfers. It is applicable to those making transfers from development to commercial, from commercial to commercial, for scale up, analytical methods or for ‘virtual’ companies.
This seminar will be of particular interest to all those from the pharmaceutical industry working in:
Personnel from the pharmaceutical and biopharmaceutical industry with the following background:
Regulatory guidance and business drivers for TT
Industry guidance for Sending and Receiving Units (SU and RU)
Science and risk-based approaches – Part one
Science and risk-based approaches – Part two
Quality risk management
Project management steps for TT – Part one
Project management steps for TT – Part two
Validation and qualification
Analytical method transfer – Part one
Analytical method transfer – Part two
Enabling successful TT – ‘Softer’ issues
Bruce Davis (21-22 May 2019)
Bruce Davis, Senior Consultant, Engineering, QbD and Qualification, Bruce Davis Global Consulting. Bruce is a professional engineer with 20 years’international experience of projects for drug substance and drug product manufacturing facilities. When he was with AstraZeneca, he led major changes to qualification processes globally as well as leading Quality by Design (QbD)cross-functional workshops for newproducts. He is ISPE’s former Chairman and Secretary to ASTM E55.03. For ISPE, he led the QbD case study, now published.