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

This course is part of our GxP training (Good x Practice) course collection, which features a variety of topic areas to ensure you comply with the most recent quality guidelines. For more information on the latest EU GMP regulations, see our GMP training course covering the Annex 1.

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

Enrol or reserve

This course will cover:

Day 1
Day 2

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

Enrol or reserve

Bruce Davis
Bruce Davis Ltd

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.

More details

NEW higher discounts for multiple bookings - bring your colleagues to make your training budget go further:

30% off the 2nd delegate*
40% off the 3rd delegate*
50% off the 4th delegate*

Please contact us for pricing if you are interested in booking 5 or more delegates

16-17 July 2024

Live online

09:00-16:30 UK (London) (UTC+01)
10:00-17:30 Paris (UTC+02)
04:00-11:30 New York (UTC-04)
Course code 13618

GBP 1,299
EUR 1,869
USD 2,129

2 days live online training
Browser-based, no download usually required
See presenters and interact with fellow attendees
Download documentation and certification of completion
Fair transfer and cancellation policy

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Not ready to book yet?

for 7 days, no obligation

7-8 October 2024

Classroom
Rembrandt Hotel
London

09:00-17:00 UK (London)
Course code 13931
Optional £240/€312/$360 per night

GBP 1,299 1,499
EUR 1,869 2,149
USD 2,137 2,449

Until 02 Sep

2 days classroom-based training
Optional accommodation - 2 nights including breakfast, checking in the day before the course
Meet presenters and fellow attendees in person
Lunch and refreshments provided
Download documentation and certification of completion
Fair transfer and cancellation policy

View basket

Not ready to book yet?

for 7 days, no obligation

* Early booking discounts may not be combined with other discounts or offers. As such, the discounts for 2nd/3rd/4th delegates are based on the full price; and apply only when booking multiple delegates on the same date.