GMP for Biological and Biotechnology Drug Substances
August 2 – 5, 2021
NSF will be delivering the ‘GMP for Biological and Biotechnology Products’ course to you over four half-day sessions between 2-5 August via our established virtual classroom. The course is presented by the course leader, John Johnson, and will be delivered from 8.30 am to 12.45 over four consecutive days to allow delegates to easily join the sessions, whether you are dialing from European or Asia-Pacific time zones.
The course will include access to pre-course information and recorded sessions, with most of the course presented live to allow for:
- Immediate Q&A with the course tutor
- Interactivity with whiteboards, polls, stamp and other interactive functionality
- Discussion, assessment and evaluation of risks concerned with cGMP as applied to biological and biotech products, their facilities, utilities and equipment
- Discussion on auditing biological and biotech production processes and associated facilities
- Focus on the requirements of EudraLex Vol IV Annex 2 and U.S. FDA GMP inspection guidelines
- Focus on the role of the quality unit, the EU Qualified Person and key operational staff
A specific recorded session introducing the particular GMP requirements of advanced therapy medical products (ATMPs)
From NSF’s research and case studies, we will also present the hot topics for the regulators, the impact of biosimilars and the key steps in outsourcing key steps of the bioprocess.
Full details will be sent to you by email following registration. NB: the email will also confirm timings for the instructor-led virtual classroom.
Course tutors: John Johnson and Emma Ewins