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2-Day Seminar: Effective Technology Transfer (London, United Kingdom – May 21-22, 2019) – ResearchAndMarkets.com

May 3, 2019 Off By BusinessWire

DUBLIN–(BUSINESS WIRE)–The “Effective
Technology Transfer” conference has been added to ResearchAndMarkets.com’s
offering.

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

Personnel from the pharmaceutical and biopharmaceutical industry with
the following background:

  • 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 quali cation specialists
  • Risk management specialists
  • Operation managers

Agenda

Day 1

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

Day 2

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

For more information about this conference visit https://www.researchandmarkets.com/r/jrlok4

Contacts

ResearchAndMarkets.com
Laura Wood, Senior Press Manager
[email protected]
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
Related
Topics: Pharmaceutical
Manufacturing