Process changes made during the manufacture of recombinant proteins can have profound implications. This 2-day course provides valuable insight into the quality, safety, efficacy and regulatory impact of manufacturing changes and how to manage process change to guarantee regulatory compliance and product consistency at all times. It features numerous case studies from industry and practical advice from our experienced professionals on the best ways to satisfy the needs of the regulators and understand how various process changes may impact the success of your products.
Dr. Robert E. Zoubek is an expert in the development, manufacturing, and analytics of biologics, as well as regulatory affairs. Until he joined Europe´s leading Consultancy Company, Granzer Regulatory Consulting & Services, he worked in several different positions at Formycon (Germany) and GlycoForm (UK). As Director of Scientific Affairs, Robert led Formycon´s drug product development and analytical services.
This course is suitable for anyone working in:
Taking place alongside BPI Europe 2019, as a delegate on this course you will also receive access to the conference exhibit areas and evening receptions offering you the opportunity to network with your peers in the industry.
BioProcess International Europe is the leading event for understanding how to accelerate your promising biologics, mAbs, vaccines and novel products towards commercial success. Register your team today and join 900+ bioprocessing scientists and engineers at this year’s meeting, held 2-5 April 2019 in Vienna.
I enjoyed the insight we were given from actual projects and the case-by-case discussions.
There was great interaction during the course as there was a small group and the open discussion was invaluable.
The course was perfect. There was a good balance between the theory of comparability and material exercises.
The practical sessions were very useful and the course content was excellent.