COURSE DESCRIPTION
The Medical Device Single Audit Program (MDSAP) allows medical device manufacturers to meet regulatory and quality system requirements in multiple markets through a single audit. Current MDSAP members include Australia, Brazil, Canada, Japan, and the United States, and others are expected to join as the program matures.
MDSAP has been required by Health Canada since January 1, 2019, which is motivating more manufacturers to adopt the program.This two-day training course provides management system practitioners with the knowledge and skills required to implement an ISO 13485:2016 Quality Management System (QMS) which meets the regulatory requirements of different medical device markets: Australia, Brazil, Canada, Japan and the United States. Moreover, this course will prepare you to host a MDSAP audit and allow you to determine if your own internal QMS processes are consistent with the requirements of the MDSAP audit mode for the jurisdictions where your products are marketed.
Objectives
This course will help you:
- Improve auditing skills focused on regulatory auditing
- Improve competence for MDSAP internal auditors and the support needed to host a MDSAP audit
- Assess your own audit models and suggest improvement·
- Be prepared to support an efficient MDSAP audit by your selected Auditing Organization
What will participants learn?
- What is the Medical Device Single Audit Program (MDSAP) and why was it developed
- What regulatory authorities participate in the MDSAP program
- The fundamentals behind the MDSAP audit model and companion guidance
The structure and scope of the MDSAP audit program, audit processes and their interrelationships
- The differences between MDSAP and other QMS audits, enhancing your existing auditing skills and be prepared to support an efficient MDSAP audit
- To identify MDSAP documentation and use correct jurisdictional terminology including reporting and nonconformity grading
Who should attend?
Quality Assurance and Regulatory Affairs professionals within medical device organizations currently active in participating territories and organizations expanding their market reach to jurisdictions participating in MDSAP.
What is included?
- Training course materials with workshop
- Training certificate (successfully passed examination / attendance)