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["sf_event_description"]=>
array(1) {
[0]=>
string(1584) "
9/10 & 9/11/2026
This comprehensive course equips internal auditors to assess conformity to ISO 13485:2016 within the new FDA Quality Management System Regulation (QMSR) framework, effective February 2, 2026, which incorporates ISO 13485:2016 and ISO 9000:2015 Clause 3 by reference.
Because internal audits are a mandatory requirement under ISO 13485, the course provides a complete foundation in planning, preparing, conducting, and evaluating internal audits in accordance with ISO 19011:2018. You’ll learn the specific audit requirements of ISO 13485, understand the characteristics of effective medical device audits, and gain confidence responding to different audit situations through practical industry examples and applied exercises.
Beyond ISO alignment, the QMSR retains several FDA‑specific provisions. You’ll learn how to extend audit criteria to verify compliance with UDI (21 CFR 830), Medical Device Reporting (803), Corrections & Removals (806), and Device Tracking (821)—critical elements auditors must now evaluate. The training also clarifies how to audit the Medical Device File (MDF) and how to map legacy structures like DMR, DHF, and DHR into the new terminology and expectations.
Recognizing the realities of the North American market, the course further addresses Canada’s CMDR requirements and essential MDSAP auditing expectations, including licensing, bilingual labeling, PMS, and the role of Auditing Organizations. This ensures your internal audit program is prepared for both U.S. and Canadian regulatory oversight."
}
["sf_event_start_date"]=>
array(1) {
[0]=>
string(18) "September 10, 2026"
}
["sf_event_start_time"]=>
array(1) {
[0]=>
string(13) "08:00:00.000Z"
}
["sf_event_end_date"]=>
array(1) {
[0]=>
string(18) "September 10, 2026"
}
["sf_event_end_time"]=>
array(1) {
[0]=>
string(13) "16:30:00.000Z"
}
["sf_sync_id"]=>
array(1) {
[0]=>
string(5) "92089"
}
["_sf_sync_id"]=>
array(1) {
[0]=>
string(19) "field_620bbf9ab741e"
}
["sf_salesforce_id"]=>
array(1) {
[0]=>
string(18) "701UY00000qchMAYAY"
}
["sf_event_maximum_attendees"]=>
array(1) {
[0]=>
string(1) "0"
}
["sf_event_status"]=>
array(1) {
[0]=>
string(9) "Cancelled"
}
["sf_event_location"]=>
array(1) {
[0]=>
string(9) "Weiss-Aug"
}
}