This course will provide attendees with a concise but comprehensive overview of all relevant regulatory, technical and quality elements necessary to assure successful design, implementation and documentation of the required CMC analytical and stability studies for biotechnology products, including biosimilar products. Key deliverables from each phase of development will be illustrated. Current ‘hot-button’ CMC analytical and stability issues will be presented, and strategies for preventing (or remediating) gaps will be presented.
Attendees will be given a USB drive containing a complete set of all regulatory documents and industry white papers currently applicable to biotechnology product analytical CMC requirements that covers the entire product development lifecycle.
This training course is intended for the professional who is involved with stability testing for biotechnology products, directly or indirectly. Professionals from Pharmaceutical, Biotechnology, Drug Delivery and Medical Device companies should attend, such as, but not limited to:
"Nadine has an open, friendly approach and encourages participation and discussion. The content was aligned with my needs, coupled with a positive review from a colleagues who had previously attended."
Principal Pharmaceutical Scientist, Medicines and Healthcare products Regulatory Agency
"There was a good amount of detailed information about many topics in this course. I particularly enjoyed biosimilars, reference standard and Forced Degradation Study."
Quality Control Manager, Rentschler Biotechnologie GmbH
"Nadine was a great speaker; very clear and interesting, setting the whole picture of the biotech world."
Quality Assessor, Croatian Medicines Agency
Nadine was really clear; it is evident that she really knows the object of this course. By using examples, she made everything really easy to understand.
I think that for a 2 day programme, it was really clearly presented and contained a lot of information.
An excellent course which answered a lot of questions and concerns