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Two Day Pharmaceutical Effective Technology Transfer Course: Focus on ICH, FDA, EU, WHO and PIC/S Guidelines (London, United Kingdom - May 21-22, 2019)

DUBLIN, May 21, 2019 /PRNewswire/ -- The "Effective Technology Transfer" conference has been added to ResearchAndMarkets.com's offering.

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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.

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 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/nq6k5z

Research and Markets also offers Custom Research services providing focused, comprehensive and tailored research.

Media Contact:

Research and Markets
Laura Wood, Senior Manager
press@researchandmarkets.com

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