Effective Technology Transfer

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

New for 2019

19-20 Nov 2019

& 21-22 Apr 2020 , 1-2 Oct 2020

GBP 1,499 1,299 *
EUR 2,099 1,819 *
USD 2,338 2,026 *
* When you book before 4 Oct

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. This event 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.

Benefits of attending:

  • Understand that technology transfer (TT) is part of the product lifecycle, 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
  • Gain understanding of 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

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 one

Regulatory guidance and business drivers for TT

ICH Q10

Exercise one

  • What makes a successful TT?

Industry guidance for sending and receiving units (SU and RU)

Knowledge

  • What do SU and RU need?

Exercise two

  • Knowledge

Science and risk-based approaches – part one

Science and risk-based approaches – part two

Equipment and utilities

Exercise three

  • Equipment at SU and RU

Quality risk management

Discussion session

Programme day two

Project management steps for TT – part one

Exercise four

  • Case study: Fishbone for TT

Project management steps for TT – part two

Exercise five

  • Case study: Organising TT

Validation and qualification

Exercise six

  • SU and RU

Analytical method transfer – part one

Analytical method transfer – part two

Enabling successful TT – ‘softer’ issues

Discussion session

Feedback

Presenter

Bruce Davis

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

19-20 Nov 2019
19-20 Nov 2019 Rembrandt Hotel, London GBP 1,499.00
EUR 2,099.00
USD 2,338.00
+ VAT @ 20.00%
GBP 1,299.00
EUR 1,819.00
USD 2,026.00
Until 4 Oct*
Enrol now
21-22 Apr 2020
21-22 Apr 2020 Venue not yet confirmed
+ VAT @ 20.00%
Enrol now
1-2 Oct 2020
1-2 Oct 2020 Venue not yet confirmed
+ VAT @ 20.00%
Enrol now

* 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
  • Genethics Regulatory Services Ltd
  • Norgine Limited
  • Norgine Ltd
  • Torbay Pharmaceuticals
  • Zambon SpA

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

Good all round course covering all aspects of Tech Transfer.

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