Objective and outcome
This course is broken down into a combination of knowledge and skills. You will increase your knowledge of the guidelines for conducting MDSAP Regulatory audits and the skills needed within your organization to know you are prepared and ready to host the audit.
 
Content
On completion, successful delegates should gain the displayed knowledge and skills:
 
Knowledge to:

• Demonstrate awareness of MDSAP fundamentals
• Explain the structure and scope of the MDSAP audit program
• MDSAP audit processes and their interrelationships
• MDSAP and organizational regulatory compliance
• MDSAP reporting and nonconformity grading
• Explain the differences between MDSAP and other QMS audits
• MDSAP and auditing in the medical device industry
• ISO 13485 and ISO 14971
• Identify MDSAP documentation

  Skills to:

• Prepare for successfully hosting a MDSAP audit:
• MDSAP 7 auditing process requirements
• Plan audit scopes
• Analyze data sources required during process audits
• Analyze control interactions
• Use correct jurisdictional terminology

Who should attend
This course is designed for anyone from the medical device industry with responsibility for one or more elements of an organization’s quality management system, including staff and top management in regulatory compliance, QA/QC, and internal auditing.
 
Trainer
Somashekara Koushik Ayalasomayajula, Senior Associate, Medidee Services SA

"It was a very knowledgeable trainer with a lot of input and proposal how to prepare for MDSAP audits"

"That the instructor was able to inform what is important and what is less important. And the examples given from other companies"

"Very informative slides, especially the first day"

"The instructor was very good and had a great knowledge of the subject. He also was good at answering questions from the participants"

"The teacher was very skilled"

"Good introduction to the overall MDSAP"

"Highly skilled and professional walk through the requirements and setup"

Participants, Fall 2021