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.
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
