2-Day Course on Effective Technology Transfer (London, United Kingdom - April 21-22, 2020) - ResearchAndMarkets.com

DUBLIN--()--The "Effective Technology Transfer" conference has been added to ResearchAndMarkets.com's offering.

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.

The 'how-to' of technology transfer across the product lifecycle

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.

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 in 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

Agenda

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

For more information about this conference visit https://www.researchandmarkets.com/r/vqtd7t

Contacts

ResearchAndMarkets.com
Laura Wood, Senior Press Manager
press@researchandmarkets.com
For E.S.T Office Hours Call 1-917-300-0470
For U.S./CAN Toll Free Call 1-800-526-8630
For GMT Office Hours Call +353-1-416-8900

Contacts

ResearchAndMarkets.com
Laura Wood, Senior Press Manager
press@researchandmarkets.com
For E.S.T Office Hours Call 1-917-300-0470
For U.S./CAN Toll Free Call 1-800-526-8630
For GMT Office Hours Call +353-1-416-8900