Speaker: Somashekara Koushik Ayalasomayajula, Quality and Regulatory Affairs Director
Date: January 31st 2024, Online
Duration: 4 hours | 7:00 – 11:00 AM (EST), 1:00 – 5:00 PM (CET)
About the Speaker: Somashekara Koushik Ayalasomayajula is a polymer engineer with 5+ years of experience within the medical device industry in product development and quality & regulatory affairs. Koushik supports our courses related to quality and regulatory affairs, deploying QMS according to ISO 13485, ISO 27001, MDR/ IVDR, integrating MDSAP, GMP requirements and in the preparation of technical documentation of medical devices for global regulatory submissions. Koushik is an ASQ-certified Medical Device Auditor (ASQ-CMDA) and holder of RAC Devices from RAPS.
Training Objectives:
- Creating awareness by understanding the principles and approach of the MDSAP program
- Explain the structure and scope of the Medical Device Single Audit Program (MDSAP)
- Understand the main requirements of the MDSAP audit processes and their interrelationships
- Understand the legal framework for medical devices in MDSAP jurisdictions
Training Content:
- MDSAP History and Introduction
- MDSAP statement of cooperation
- MDSAP members
- Regulatory Authority Council (RAC)
- Regulatory landscape in MDSAP territories and outcomes
- Benefits of MDSAP
- Overview of the regulatory landscape in MDSAP territories
- MDSAP structure and scope
- MDSAP Audit cycle
- MDSAP process interactions
- MDSAP audit approach
- MDSAP post-audit activities
- Generalities
- Non-conformity grading
- 5-day rule
- Preparatory steps for successful MDSAP certification
Training Format:
- Presentation with interactive discussions
- Exercises during the training
- End of training assessment (participants will receive a training certificate)
Prerequisite:
Attendees are expected to have a solid background in the requirements of ISO 13485:2016.
Who Should Attend:
- Quality Assurance and Regulatory Affairs professionals within medical device organizations currently active in participating territories and/ or organizations expanding their market reach to jurisdictions participating in MDSAP
- Middle Management, Regulatory professionals, or anyone interested in conducting and participating in quality and regulatory audits.
Price:
EUR 620 including course material and certificate