| Revision |
GCP03 |
Obligations of Investigators in Conducting Medical Device Trials
|
QA/GMP Trainer |
Medical Device Catalog;
Clinical: Medical Device Library |
2.1 |
Updated references |
Course |
05/07/2026 |
| Minor Update |
PHDV93 |
Combination Products: cGMP Requirements
|
QA/GMP Trainer |
Pharmaceutical GMPs Library;
Pharmaceutical Catalog;
Medical Device GMPs Library;
Medical Device Catalog |
2.2 |
Updated multiple references throughout course to comply with FDA Harmonization with ISO13485. Updated questions to match. |
Course |
05/13/2026 |
| Revision |
EHS117 |
DOT Hazardous Materials Training -- Carrier Requirements (Rail)
|
EHS Manager |
Pharmaceutical Catalog;
Medical Device Catalog;
HealthCare Catalog;
EHS for Life Science - Basics Library |
1.0 |
Updated to remove dead or expired weblinks used for reporting resources. |
Course |
05/13/2026 |
| Minor Update |
MAPD05 |
Special Needs Plans: Model of Care
|
Corporate Compliance |
Medicare Part D Library;
Medicare Advantage Library;
HealthCare Catalog |
2.3 |
Updated to align the requirements to the 2026 NCQA scoring guidelines. |
Course |
05/18/2026 |
| Minor Update |
BIMO02 |
BIMO: General Inspection Assignment Process
|
Clinical Quality Manager |
Pharmaceutical Catalog;
Medical Device Catalog;
FDA BIMO Course Library |
2.5 |
Added 3 new guidance document references, and added statement on inspectors using multi resources. |
Course |
05/22/2026 |
| Revision |
DATA05 |
Data Integrity for Clinical Research Staff
|
QA/GMP Trainer;
QA Auditor |
Pharmaceutical Catalog;
Medical Device Catalog;
HealthCare Catalog;
Data Integrity Library |
1.3 |
Updated guidance document references. |
Course |
05/22/2026 |
| Minor Update |
PHDV94 |
Japanese Medical Device and Pharmaceutical Regulations
|
QA/GMP Trainer |
Pharmaceutical Catalog;
Medical Device Catalog;
Global Regulatory Library |
4.1 |
Updated to include latest Amendment of PMD Act - 14 May 2025. |
Course |
05/22/2026 |
| Minor Update |
DATA03 |
Data Integrity: The Role of Quality Assurance for Data Integrity
|
QA/GMP Trainer;
QA Auditor |
Pharmaceutical Catalog;
Medical Device Catalog;
HealthCare Catalog;
Data Integrity Library |
1.5 |
Updated to include changes to list new ISO 13485 references and notations against each equivalent FDA regulation. |
Course |
05/22/2026 |
