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
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
Related
Topics: Pharmaceutical
Manufacturing