Requirements of GMP Production
M12
Course Goals
Requirements for GMP-production of vaccines or other drug substances regarding technical, analytical and regulatory aspects.
Timeline
Application Deadline:
18 July 2021
Course Dates:
08-09 November 2021 (2days)
Organiser
Fraunhofer IME,
Aachen Germany
Nr of Participants: max 15
Contact
Holger Spiegel holger.spiegel@ime.fraunhofer.de
Course content
Day1:
• Introduction into GMP
• GMP-Infrastructure: Planning, Construction, and Approval
• Regulatory aspects of vaccine development in the context of GMP production requirements
• Practical session: CMC sections of IMPD, IND, CTG
Day2:
• Analytical Method development (Case study)
• A CMOs perspective on GMP process translation
• GMP facility tour
Learning Outcomes
Deeper insight into the requirements for GMP-production of vaccines or other drug substances.
Who should apply
Scientists involved or interested in vaccine R&D and manufacturing projects.
Minimal requirements
Self-assessment of “GMP-status” provided in application form.
Accommodation
Accommodation will be provided. Travel Costs are not included.
Comments
* Due to COVID19 related delays call and training modules' schedule may be subject to change.
Weblink
NA