Presented by
Management Forum

Effective Technology Transfer

The ‘how to’ of technology transfer across the product lifecycle

11-12 Jan 2022 + 3 more dates

Enrol now

  • Format: Classroom, Live online
  • CPD: 12 hours for your records
  • Certificate of completion

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

Enrol now

The Effective Technology Transfer course will cover:

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 now

Bruce Davis

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

Book Effective Technology Transfer Classroom/Live online training

11-12 Jan 2022

Classroom
London venue TBC

09:00-17:00 UK (London)
Course code 11395

  • GBP 1,299 1,499
  • EUR 1,819 2,099
  • USD 2,026 2,338

Until 07 Dec

  • 2 days classroom-based training
  • Meet presenters and fellow attendees in person
  • Lunch and refreshments provided
  • Download documentation and certification of completion
  • Fair transfer and cancellation policy

In your basket 

6-7 Apr 2022

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 11600

  • GBP 1,099 1,299
  • EUR 1,579 1,859
  • USD 1,786 2,098

Until 02 Mar

In your basket 

4-5 Jul 2022

Classroom
London venue TBC

09:00-17:00 UK (London)
Course code 11883

  • GBP 1,299 1,499
  • EUR 1,819 2,099
  • USD 2,026 2,338

Until 30 May

  • 2 days classroom-based training
  • Meet presenters and fellow attendees in person
  • Lunch and refreshments provided
  • Download documentation and certification of completion
  • Fair transfer and cancellation policy

In your basket 

11-12 Oct 2022

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 11748

  • GBP 1,099 1,299
  • EUR 1,579 1,859
  • USD 1,786 2,098

Until 06 Sep

In your basket 

Reviews of IPI's Effective Technology Transfer training course


[The speaker] was very friendly, professional and thoughtful. He encouraged all the trainees to participate in the exercises in a very positive & constructive way.

Oct 5 2021

Grace Jung
Senior Scientist, Design Transfer, Speedx Pty Ltd

Nov 19 2019

The course was absolutely great and to get helpful advice from the experienced speaker was fantastic.

Ulrike Ratz
CMC Manager, Cheplapharm Arzneimittel GmbH

May 21 2019

Good all round course covering all aspects of Tech Transfer.

Frances Morrissey
Product Specialist - Global Technical Management, Norgine Limited

May 21 2019

Really worthwhile course that I would recommend to my colleagues. I have several practical tools that will help me in my future technology transfers.

Laura Hearthward
Product Development Manager, Torbay Pharmaceuticals

UK

  • Arecor Ltd
  • Genethics Regulatory Services
  • Norgine Limited
  • Norgine Ltd
  • Sekisui Diagnostics
  • Torbay Pharmaceuticals

Germany

  • Aristo Pharma GmbH
  • Bayer Consumer Care AG
  • Cheplapharm Arzneimittel GmbH

Italy

  • Chiesi Farmaceutici S.p.a.
  • Zambon SpA

Switzerland

  • Celonic AG
  • Ichnos Sciences

Australia

  • Speedx Pty Ltd

Austria

  • Boehringer Ingelheim Pharma Co.KG

Denmark

  • Fujifilm Diosynth Biotechnologies

Ireland

  • Avectas

Netherlands

  • Amgen

Norway

  • Oslo universitetssykehus

Spain

  • Instituto GrifolsS.A

Enrol now

Multiple colleagues?
Talk to one of our training experts to discuss how to:

Run this course conveniently and cost-effectively in-house for your staff and colleagues

Aleksandra BEER
Training expert

+44 (0)20 7749 4749

inhouse@ipi.academy