The how-to' of technology transfer across the product lifecycle
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 in 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
Programme day one
Regulatory guidance and business drivers for TT
- What makes a successful TT?
Industry guidance for sending and receiving units (SU and RU)
- What do SU and RU need?
Science and risk-based approaches - part one
Science and risk-based approaches - part two
Equipment and utilities
- Equipment at SU and RU
Quality risk management
Programme day two
Project management steps for TT - part one
- Case study: Fishbone for TT
Project management steps for TT - part two
- Case study: Organising TT
Validation and qualification
- SU and RU
Analytical method transfer - part one
Analytical method transfer - part two
Enabling successful TT - softer' issues
For more information about this conference visit https://www.researchandmarkets.com/r/j7h5fu