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Effective Technology Transfer Training Course: face to face & live webinar

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

1-2 Oct 2020

& 20-21 Apr 2021 , 5-6 Oct 2021

Book now

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 - day 1

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)

Exercise 2: Knowledge


Science and risk-based approaches

Equipment and utilities

Exercise 3: Equipment at SU and RU


Quality risk management

Programme - day 2

Project management steps for TT

Exercise 4 - Case Study - Fishbone for TT


Exercise 5: Case Study - Organising TT


Exercise 6: SU And RU


Analytical method transfer

Enabling successful TT – ‘softer’ issues

Presenter

Bruce Davis (More...)

Bruce Davis, Senior Consultant, Engineering, QbD and Qualification, Bruce Davis Global Consulting. Bruce is a professional engineer with 20 years’international experience of projects for drug substance and drug product manufacturing facilities. When he was with AstraZeneca, he led major changes to qualification processes globally as well as leading Quality by Design (QbD)cross-functional workshops for newproducts. He is ISPE’s former Chairman and Secretary to ASTM E55.03. For ISPE, he led the QbD case study, now published.

Book now

  attend Face to face attend Live webinar
1-2 Oct 2020, Cavendish Hotel, London
1-2 Oct 2020 Cavendish Hotel, London GBP 1,299.00
EUR 1,819.00
USD 2,026.00
Until 20 Aug*
Enrol now
to attend
Face to face
GBP 1,099.00
EUR 1,579.00
USD 1,786.00
Until 20 Aug*
Enrol now
to attend
Live webinar
20-21 Apr 2021, Venue not yet confirmed
20-21 Apr 2021 Venue not yet confirmed GBP 1,299.00
EUR 1,819.00
USD 2,026.00
Until 9 Mar 21*
Enrol now
to attend
Face to face
GBP 1,099.00
EUR 1,579.00
USD 1,786.00
Until 9 Mar 21*
Enrol now
to attend
Live webinar
5-6 Oct 2021, Venue not yet confirmed
5-6 Oct 2021 Venue not yet confirmed GBP 1,299.00
EUR 1,819.00
USD 2,026.00
Until 24 Aug 21*
Enrol now
to attend
Face to face
GBP 1,099.00
EUR 1,579.00
USD 1,786.00
Until 24 Aug 21*
Enrol now
to attend
Live webinar

Learn more about our different training formats.

* Note the early booking discount cannot be combined with any other offers or promotional code

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Previous customers include...

  • Avectas Ltd
  • Bayer Consumer Care AG
  • Boehringer Ingelheim Pharma Co.KG
  • Cheplapharm Arzneimittel GmbH
  • Chiesi Farmaceutici S.p.a.
  • Genethics Regulatory Services Ltd
  • Ichnos Sciences
  • Norgine Limited
  • Norgine Ltd
  • Sekisui Diagnostics
  • Torbay Pharmaceuticals
  • Zambon SpA

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

Ulrike Ratz, CMC Manager, Cheplapharm Arzneimittel GmbH, Nov 19

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, May 19

Good all round course covering all aspects of Tech Transfer.

Frances Morrissey, Product Specialist - Global Technical Management, Norgine Limited, May 19