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 benefits and assure product quality.
Attending this highly practical course 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.
The programme covers pharmaceutical products, including ATMPs and combination products, but does not include medical devices.
Benefits of attending:
This seminar will be of particular interest to all those from the pharmaceutical industry working in:
The following personnel from the pharmaceutical and biopharmaceutical industries will also find it beneficial:
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
Equipment and utilities
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, 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.
|21-22 Apr 2020|
|21-22 Apr 2020||Rembrandt Hotel, London||GBP 1,499.00
+ VAT @ 20.00%
Until 13 Mar*
|1-2 Oct 2020|
|1-2 Oct 2020||Cavendish Hotel, London||GBP 1,499.00
+ VAT @ 20.00%
* Note the early booking discount cannot be combined with any other offers or promotional code