Summary
This three-day course will give you a thorough understanding of the Notified Body application process as well as a comprehensive regulatory update. You will understand the responsibilities and expectations of Notified Bodies and get the necessary tools to achieve a good submission.
Learning Objectives
- Gain a comprehensive overview of the NB application process
- Understand where the NB responsibility starts and ends
- Design and development activities necessary for a successful NBO
- Why EN ISO13485:2016 will help achieve a good submission
- Understanding risks, requirements, and standards in the context of generating evidence of conformity
- Using the GSPR checklist as a means to manage your design and development file
Key Topics
- Notified Body (NB) application & review process
- Regulatory requirements (EU MDR)
- EN ISO13485:2016
- General Safety and Performance Requirements (GSPR)
- CE marking
Who should attend?
This course is suitable for all those involved in:
- Regulatory Affairs
- Quality Control/ Assurance/ Engineering
- Product Development/ Engineering/ Technology Transfer
- Process Development
- Research & Development
Past participants
- Global Head External Quality, Biogen
- QA Manager, F. Hoffmann-La Roche
- Senior Manager GLP/GMP, Merz Pharmaceuticals
- Senior Technical Regulatory Affairs Manager, Idorsia Pharmaceuticals
- Senior Technical Steward Devices, Novartis
- Manager, External Manufacturing Management, Ferring
- R&D Engineer, Cook Medical
- Principle Scientist Lead Combination Products, Lonza
- Process Engineer, Novo Nordisk
- Quality Manager, Boston Scientific
- Global DRA Project Leader, Idorsia Pharmaceuticals
- Design Team Manager, Owen Mumford
- Development Engineer, Leo Pharma
- Regulatory Affairs Manager, Novavax
- Head of Regulatory Affairs, Vectura
Our online training experience includes
- Our client zone – a single source for all training materials as well as pre and post-training communication
- Live interactive format via the Zoom platform
- Direct interaction with the trainer
- Q&As, case studies, polls
- Revisit recorded sessions for 7 days
- Training in digital format
- Digital and LinkedIn certificates
Trainers
Drug-Device Combination Products: Notified Body Opinion Process
Download the full training agenda to reveal complete session details, training takeaways, case studies, daily schedule, special features and full trainer bio.
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