Training of internal auditors in relation to country specific requirements within the MDSAP program
The specific national requirements of the participating jurisdictions will be addressed with examples sampled over the subsystems
MDSAP is an auditing approach integrating the applicable requirements of the participating jurisdictions into an audit under ISO 13485. ISO 13485 requires compliance to applicable regulatory requirements of the target markets and the MDSAP defines the framework of the applicable requirements that must be covered by the manufacturers’ quality systems for the MDSAP jurisdictions.
Course objective and outcome
The course discusses the MDSAP audit approach that is focused on the logical links and flow of information. Further, we will discuss the logic of the audit to follow according to the MDSAP Companion chapters throughout the different subsystems. The specific national requirements of the participating jurisdictions (Ord.169, 21CFR820, RDC 16/2013, SOR 98-282, TGA MDR 2002) will be addresses and compared using examples sampled over the subsystems.
Attendees of the course will
Understand the MDSAP policies and audit approach
Know where to locate information
Discuss and interpret MDSAP subjects related to ISO 13485 requirements
Discuss evidence expected for fulfilling some of the specific requirements of participating jurisdictions
The Medical Device Single Audit Program, policies, coverage
MDSAP Audit approach
Prepare for hosting a MDSAP audit
Overview of MDSAP Companion Chapters and links within Subsystems
Auditing management system subsystems
Auditing coverage of specific requirements of MDSAP jurisdictions and comparison of Ord.169, 21CFR820, RDC 16/2013, SOR 98-282, TGA MDR 2002 with referenced ISO 13485 clauses.
Who should attend
Quality system and Regulatory professionals with audit experience (trained internal auditors / experience to be exposed to FDA inspections or Notified Body Audits)
Michael Maier, Senior Partner, Medidee Services SA