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Effective Technology Transfer

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

Customised in-house training course

The content, presenters and format of this course are customised to your requirements.

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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.

Customise

Customise & book

This course can be customised to meet your requirements, and delivered to your colleagues at your location or online. For more information, call us on +44 (0)20 7749 4730, email us at inhouse@management-forum.co.uk or contact us below:

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Continuing professional development

This course qualifies for 12 hours for your CPD records.
More about CPD

Training options

Public course dates

We can deliver and customise this course for any number of attendees, at your location or online. But if you have fewer colleagues, this course is running publically on:

  • 11-12 Jan 2022
  • 6-7 Apr 2022
  • 4-5 Jul 2022
  • 11-12 Oct 2022

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You may also be interested in

Previous customers include...

  • Amgen
  • Arecor Ltd
  • Aristo Pharma GmbH
  • Avectas Ltd
  • Bayer Consumer Care AG
  • Boehringer Ingelheim Pharma Co.KG
  • Celonic AG
  • Cheplapharm Arzneimittel GmbH
  • Chiesi Farmaceutici S.p.a.
  • Fujifilm Diosynth Biotechnologies
  • Genethics Regulatory Services Ltd
  • Grifols S.A.
  • Ichnos Sciences
  • Norgine Limited
  • Norgine Ltd
  • Oslo universitetssykehus
  • Sekisui Diagnostics
  • SpeeDx Pty Ltd
  • Torbay Pharmaceuticals
  • Zambon SpA

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

Grace Jung , Senior Scientist, Design Transfer, Speedx Pty Ltd , Oct 21

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

Good all round course covering all aspects of Tech Transfer.

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