Technology transfer (TT) includes knowledge transfer and the application of science and risk-based principles including ICH Q8, Q9, Q10, Q11, to support the business requirements from both Sending and Receiving units for drug substance, drug product and analytical procedures.
Technology transfer occurs in many circumstances involving for example active pharmaceutical ingredients (APIs), finished dosage forms and analytical methods. TTs may occur between development and manufacturing sites or to contract manufacturing organizations (CMOs).
This course identifies criteria for successful technology transfer and provides examples and tools for industry and regulators to use when conducting and evaluating technology transfer activities.
Understand technology transfer planning and success criteria including
This course is intended to be useful to anyone involved in technology transfer whether in relation to commercial transfer between manufacturing sites or transfer to manufacturing from development or within development but will be particularly relevant to professionals with technology transfer responsibilities, including regulatory compliance associates, process development scientists, facilities engineers, validation and quality assurance specialists, manufacturing managers, and regulators
Bruce Davis, Principal, Global Consulting is a professional engineer, and has many years' experience in the pharmaceutical industry and a wide international knowledge, and operates a consultancy in QbD, Engineering, Process Validation and reducing Human Error. He is an Associate to NSF-DBA, the training & consultancy Company. He previously worked at AstraZeneca, where he had a number of responsibilities, including managing international engineering, and this extended to provision of sterile facilities. Davis has been a member of ISPE since 1991, and is a member of the United Kingdom Affiliate. He has held the position of Chair of ISPE International Board of Directors and has been active in supporting ISPE, including leading the team writing the original Sterile Baseline® Guide and its current update. He also led ISPE's case study for practical implementation of Quality by Design (QbD) and is currently co-chairing the team updating ISPE's Technology Transfer Guide. Davis also facilitated the change to qualification to enable science and risk based principles to be adopted. Previous experience includes the position of past secretary to ASTM E55.03 Committee on General Pharmaceutical Standards and leading the team that set up a distance-learning course, for a UK university, involving some 40 webinars.
Maurice Parlane is Principal of New Wayz Consulting Ltd in New Zealand and a Director of CBE Pty Ltd in Australia. He is a professional engineer with 30 years' experience within the biopharmaceutical industry, including 20 years as an industry consultant providing support to manufacturing and compliance management; validation and operational excellence projects in Australasia and the Asia Pacific region. Prior to this, he held senior engineering and manufacturing roles within the Glaxo group of companies. He has a Bachelor of Manufacturing Technology (Hons) as well as mechanical and electrical engineering qualifications. Maurice is past president and current director of the ISPE Australasian Affiliate. He is the co-lead of ISPE's Asia Pacific Regulatory and Quality Harmonization committee and a member of the PV and Guidance Document committees. He is an ISPE PV Instructor and was named ISPE Member of the year in 2016.
Members may immediately apply the course learning objectives by accessing the electronic version of the ISPE Good Practice Guide: Technology Transfer (Third Edition)
Trainers will refer to the Guide during this course, using relevant excerpts. If you wish to buy a printed edition of the guide, which will be shipped and distributed on day 1 of the course, please indicate when registering.
Member US$ 150 / Non-member US$ 460
|Price in SGD per delegate||Members||Non-members|
|Early Bird *||S$1,095||S$1,395|
|Group Rate **||S$1,095||S$1,395|
If you have any questions or need assistance with your registration, please contact Kristina Autenrieth at email@example.com.