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Effective Technology Transfer Training Course
The ‘how to’ of technology transfer across the product lifecycle
Details
Course overview
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
Who should attend
This seminar will be of particular interest to all those from the pharmaceutical industry working in:
- Development
- Manufacturing
- Engineering
- Quality
The following personnel from the pharmaceutical and biopharmaceutical industries will also find it beneficial:
- Pharmacists
- Scientists
- Engineers
- Quality assurance professionals
- Quality control managers
- Late-stage product and process development engineers, scientists, pharmacists
- Technology scale-up and transfer managers
- Validation and qualification specialists
- Risk management specialists
- Operation managers
Programme
Regulatory guidance and business drivers for TT
ICH Q10
Exercise 1 - What Makes a Successful TT?
Industry guidance for sending and receiving units (SU and RU)
Knowledge
- What do SU and RU need?
Exercise 2: Knowledge
Science and risk-based approaches - part one
Science and risk-based approaches - part two
Equipment and utilities
Exercise 3: Equipment at SU and RU
Quality risk management
Project management steps for TT - part one
Exercise 4 - Case Study - Fishbone for TT
Project management steps for TT - part two
Exercise 5: Case Study - Organising TT
Validation and qualification
Exercise 6: SU And RU
Analytical method transfer - part one
Analytical method transfer - part two
Enabling successful TT – ‘softer’ issues
Presenter
Bruce Davis (More...)
Bruce Davis runs his own training/consultancy company for science and risk based approaches to Engineering and Process Validation (PV), Quality by Design (QbD), Technology Transfer (TT), Quality Risk Management and other related topics. He has run many training events for companies both in the UK and internationally. He is past Chair of ISPE International Board of Directors. He led, co-lead or contributed to a number of their guidances for PV, QbD & TT and most recently has co-written one chapter on TT for ATMPs (i.e personalised medicines) . He is a professional engineer with many years’ experience in the pharmaceutical industry and a wide international knowledge. He previously worked at AstraZeneca, where his responsibilities included managing international engineering and leading changes to qualification practices. He is an established trainer and likes to engage with participants, to try to ensure the training experience is related to their particular requirements, and to bring in the importance of science and risk based thinking.
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11-12 Jan 2022 Face-to-face, (venue not yet confirmed) |
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11-12 Jan 2022 Face-to-face (venue not yet confirmed) |
GBP 1,499 1,299 EUR 2,099 1,819 USD 2,338 2,026 Until 7 Dec* |
Enrol now
to attend Face-to-face (venue not yet confirmed) |
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6-7 Apr 2022 Live webinar |
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6-7 Apr 2022 Live webinar |
GBP 1,299 1,099 EUR 1,859 1,579 USD 2,098 1,786 Until 2 Mar 22* |
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to attend Live webinar |
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4-5 Jul 2022 Face-to-face, (venue not yet confirmed) |
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4-5 Jul 2022 Face-to-face (venue not yet confirmed) |
GBP 1,499 1,299 EUR 2,099 1,819 USD 2,338 2,026 Until 30 May 22* |
Enrol now
to attend Face-to-face (venue not yet confirmed) |
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11-12 Oct 2022 Live webinar |
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11-12 Oct 2022 Live webinar |
GBP 1,299 1,099 EUR 1,859 1,579 USD 2,098 1,786 Until 6 Sep 22* |
Enrol now
to attend Live webinar |
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* Note the early booking discount cannot be combined with any other offers or promotional code