Effective Technology Transfer
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:
- Understand that technology transfer (TT) is part of the product life cycle, supported by the pharmaceutical quality system
- Know where TT is covered in ICH, FDA, EU, WHO and PIC/S guidelines
- Learn the key steps for successful transfers
- Know how to engage sending and receiving units (SU and RU) for TT
- Understand how product and process understanding enables TT
- Apply tools such as quality risk management and clarify risks involved in TT
- Understand how change should be handled, eg facility and equipment differences between SU and RU; scale-up
- Learn how analytical method transfers are an integral part of TT
- Recognise how TT impacts a wide range of companies from innovative to generic, including development, manufacturing, major corporations and ‘virtual’ companies
- Realise how significant business benefits emerge from successful TT
- Understand TT for pharmaceutical products, including combination products and ATMPs
Upcoming start dates
16 April, 2024
16 July, 2024
- Self-Paced Online
7 October, 2024
Request information - obligation free
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Reviews by course attendees
Average rating 4.8
The explanations of the proposed topics were very acceptable and the relation between the theoretical and practical parts was very outstanding.
It was a very useful training that fulfil my necessities about the Industry standards for the Technology transfers... Bruce is very knowledgeable and he was continuously asking ...
Everything set in the agenda was covered. No issues with presentation, if any help required we were able to privately message Natalia. The speed at which Bruce spoke through the...