DUBLIN–(BUSINESS WIRE)–The “Effective Technology Transfer Training Course” 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.
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.
Benefits of attending:
Who Should Attend:
This seminar will be of particular interest to all those from the pharmaceutical industry working in:
The following personnel from the pharmaceutical and biopharmaceutical industries will also find it beneficial:
Key Topics Covered:
Regulatory guidance and business drivers for TT
ICH Q10
Exercise 1 – What Makes a Successful TT?
Exercise 2: Knowledge
Exercise 3: Equipment at SU and RU
Exercise 4 – Case Study – Fishbone for TT
Exercise 5: Case Study – Organising TT
Exercise 6: SU And RU
Speakers
Bruce Davis
Associate
NSF Healthsciences
Bruce Davis runs his own training/consultancy company for science and risk based approaches to Engineering and Process Validation (PV), Quality by Design (QbD), Quality Risk Management, GMP for Engineers and other related topics. He has run many training events for companies both in the UK and internationally and is often invited to speak at international conferences.
He is past Chair of ISPE International Board of Directors and led their case study for practical implementation of QbD. He co-chaired the team updating their Technology Transfer (TT) Guide and carries out training for them and other organisations.
He is a professional engineer and has many years’ experience in the pharmaceutical industry and a wide international knowledge, and understanding of current regulatory approaches in the above topics for both US and EU.
He previously worked at AstraZeneca, where he had a number of responsibilities, including managing international engineering, facilitating QbD and leading changes to qualification practices.
He played a leadership role to set up De Montfort University’s MSc distance learning course in QbD.
He is an Associate to NSF Healthsciences, and for them has carried out consultancy and training in the above topic areas, and also for driving down human error.
For more information about this conference visit https://www.researchandmarkets.com/r/cprz1i
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
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