Major Update |
PS5-100379 |
Line Breaking (US)
|
General Industry and Manufacturing; General Industry and Manufacturing |
Safety Catalog |
N/A |
Full SME Review, Test, Job Aid. |
Course |
09/05/2025 |
Revision |
LAV19 |
Confidentiality, Intellectual Property Protection, and Information Security
|
Corporate Compliance |
Pharmaceutical Catalog; Medical Device Catalog; HR Compliance & Risk Management Library; HealthCare Catalog; Ethics & Corporate Responsibility Library |
2.2 |
Course branding change only. |
Course |
09/04/2025 |
Revision |
LAV21 |
Harassment in the Workplace
|
All Industries |
Pharmaceutical Catalog; Medical Device Catalog; HR Compliance & Risk Management Library; Ethics & Corporate Responsibility Library; Emerging Business - Pharmaceutical Library; Emerging Business - Medical Device Library |
2.0 |
Course branding change only. |
Course |
09/04/2025 |
Revision |
LAV22 |
Harassment Avoidance Training for California
|
Corporate Compliance |
Pharmaceutical Catalog; Medical Device Catalog; HR Compliance & Risk Management Library; HealthCare Catalog; Ethics & Corporate Responsibility Library |
3.1 |
Course branding change only. |
Course |
09/04/2025 |
Revision |
LAV23 |
Sexual Harassment Awareness for New York Employees and Supervisors
|
HR Compliance & Risk Management; Corporate Compliance |
Pharmaceutical Catalog; Medical Device Catalog; HR Compliance & Risk Management Library; HealthCare Catalog; Ethics & Corporate Responsibility Library |
2.0 |
Course branding change only. |
Course |
09/04/2025 |
Revision |
LAV24 |
Sexual Harassment Awareness for California Employees
|
Corporate Compliance |
Pharmaceutical Catalog; Medical Device Catalog; HR Compliance & Risk Management Library; HealthCare Catalog; Ethics & Corporate Responsibility Library |
1.3 |
Course branding change only. |
Course |
09/04/2025 |
Revision |
LAV25 |
Sexual Harassment Awareness for Employees and Supervisors (All States except California)
|
HR Compliance & Risk Management |
Pharmaceutical Catalog; Medical Device Catalog; HR Compliance & Risk Management Library; HealthCare Catalog; Ethics & Corporate Responsibility Library |
1.0 |
Course branding change only. |
Course |
09/04/2025 |
Revision |
MDR01 |
EU Medical Device Regulation (MDR)
|
QA Auditor |
Pharmaceutical Catalog; Medical Device GMPs Library; Medical Device Catalog; Global Regulatory Library |
2.3 |
Course branding change only. |
Course |
09/04/2025 |
Revision |
MDR02 |
EU In Vitro Diagnostic Regulations (IVDR)
|
QA Auditor |
Pharmaceutical Catalog; Medical Device GMPs Library; Medical Device Catalog; Global Regulatory Library |
2.3 |
Course branding change only. |
Course |
09/04/2025 |
Revision |
MDR03 |
CE Certification for Medical Devices
|
QA Auditor |
Pharmaceutical Catalog; Medical Device GMPs Library; Medical Device Catalog; Global Regulatory Library |
3.2 |
Course branding change only. |
Course |
09/04/2025 |
Revision |
MDSAP_Australia |
Australia Therapeutic Goods Administration (TGA) MDSAP Specific
|
QA/GMP Trainer |
Medical Device Catalog; MDSAP Library |
3.0 |
Course branding change only. |
Course |
09/04/2025 |
Revision |
MDSAP_Brazil |
Brazil Agencia Nacional de Vigilancia Sanitaria (ANVISA) MDSAP Country-Specific Tasks
|
QA/GMP Trainer |
Medical Device Catalog; MDSAP Library |
1.2 |
Course branding change only. |
Course |
09/04/2025 |
Revision |
MDSAP_Canada |
Health Canada - MDSAP Country-Specific Tasks
|
QA/GMP Trainer |
Medical Device Catalog; MDSAP Library |
1.2 |
Course branding change only. |
Course |
09/04/2025 |
Revision |
MDSAP_Japan |
Japan Ministry of Health, Labour and Welfare (MHLW) MDSAP Country-Specific Tasks
|
QA/GMP Trainer |
Medical Device Catalog; MDSAP Library |
1.2 |
Course branding change only. |
Course |
09/04/2025 |
Revision |
MDSAP_US |
United States Food and Drug Administration (FDA) MDSAP Country-Specific Tasks
|
QA/GMP Trainer |
Medical Device Catalog; MDSAP Library |
1.1 |
Course branding change only. |
Course |
09/04/2025 |
Revision |
MDSAP00 |
Overview of the Medical Device Single Audit Program (MDSAP) Chapter Structure
|
|
Medical Device Catalog; MDSAP Library |
1.1 |
Course branding change only. |
Course |
09/04/2025 |
Revision |
MDSAP01 |
MDSAP Chapter 1 Process Management
|
|
Medical Device Catalog; MDSAP Library |
1.1 |
Course branding change only. |
Course |
09/04/2025 |
Revision |
MDSAP02 |
MDSAP Chapter 2 Process: Device Marketing Authorization and Facility Registration
|
|
Medical Device Catalog; MDSAP Library |
1.1 |
Course branding change only. |
Course |
09/04/2025 |
Revision |
MDSAP03 |
MDSAP Chapter 3 Process: Measurement, Analysis, and Improvement
|
|
Medical Device Catalog; MDSAP Library |
1.2 |
Course branding change only. |
Course |
09/04/2025 |
Revision |
MDSAP04 |
MDSAP Chapter 4 Process: Medical Device Adverse Events and Advisory Notices
|
|
Medical Device Catalog; MDSAP Library |
1.1 |
Course branding change only. |
Course |
09/04/2025 |
Revision |
MDSAP05 |
MDSAP Chapter 5 Process: Design and Development
|
|
Medical Device Catalog; MDSAP Library |
1.1 |
Course branding change only. |
Course |
09/04/2025 |
Revision |
MDSAP06_01 |
MDSAP Chapter 6 Process - Production and Service Controls - Part 1
|
Pharmaceutical |
Medical Device Catalog; MDSAP Library |
1.1 |
Course branding change only. |
Course |
09/04/2025 |
Revision |
MDSAP06_02 |
MDSAP Chapter 6 Process - Production and Service Controls - Part 2
|
QA/GMP Trainer |
Medical Device Catalog; MDSAP Library |
1.1 |
Course branding change only. |
Course |
09/04/2025 |
Revision |
MDSAP07 |
MDSAP Chapter 7: Process: Purchasing
|
Pharmaceutical |
Medical Device Catalog; MDSAP Library |
1.1 |
Course branding change only. |
Course |
09/04/2025 |
Revision |
MDSM02 |
Reporting Adverse Events for Medical Devices
|
Medical Device |
Medical Device Catalog; Medical Device - Sales & Marketing Library |
3.2 |
Course branding change only. |
Course |
09/04/2025 |
Revision |
MDSM03 |
Massachusetts Pharmaceutical and Medical Device Manufacturer Conduct Regulation (Mass. Code) and Similar State-Level Requirements
|
Corporate Compliance |
Medical Device Catalog; Medical Device - Sales & Marketing Library |
3.2 |
Course branding change only. |
Course |
09/04/2025 |
Revision |
MDSM04 |
MedTech Europe Code of Ethical Business Practice
|
Medical Device |
Medical Device Catalog; Medical Device - Sales & Marketing Library |
4.1 |
Course branding change only. |
Course |
09/04/2025 |
Revision |
MDSM07 |
National Patient Safety Goals: HCIR Credentialing
|
Sales Operations |
Medical Device Catalog; Medical Device - Sales & Marketing Library |
3.0 |
Course branding change only. |
Course |
09/04/2025 |
Revision |
PCV01_A |
Drug Safety and Pharmacovigilance: Assessing
|
Pharmaceutical; Medical Device |
Pharmacovigilance Library |
1.0 |
Course branding change only. |
Course |
09/04/2025 |
Revision |
PCV01_B |
Drug Safety and Pharmacovigilance: Reporting
|
Pharmaceutical; Medical Device |
Pharmacovigilance Library |
1.0 |
Course branding change only. |
Course |
09/04/2025 |
Revision |
PCV02_A |
Pharmacovigilance: Global Requirements - Regulations and Guidances
|
Pharmaceutical; Medical Device |
Pharmacovigilance Library |
1.0 |
Course branding change only. |
Course |
09/04/2025 |
Revision |
PCV02_B |
Pharmacovigilance: Global Requirements - Systems
|
Pharmaceutical; Medical Device |
Pharmacovigilance Library |
1.0 |
Course branding change only. |
Course |
09/04/2025 |
Revision |
PCV03_A |
Pharmacovigilance Audit and Inspection: Preparation
|
Pharmaceutical; Medical Device |
Pharmacovigilance Library |
1.0 |
Course branding change only. |
Course |
09/04/2025 |
Revision |
PCV03_B |
Pharmacovigilance Audit and Inspection: Dos and Don'ts
|
Pharmaceutical; Medical Device |
Pharmacovigilance Library |
1.0 |
Course branding change only. |
Course |
09/04/2025 |
Revision |
PCV04_A |
Assessing Data: Pharmacovigilance Signaling
|
Pharmaceutical; Medical Device |
Pharmacovigilance Library |
1.0 |
Course branding change only. |
Course |
09/04/2025 |
Revision |
PCV04_B |
Assessing Data: Data Mining and Risk Management
|
Pharmaceutical; Medical Device |
Pharmacovigilance Library |
1.0 |
Course branding change only. |
Course |
09/04/2025 |
Revision |
PCV05_A |
Device Safety and Vigilance: Assessing
|
Pharmaceutical; Medical Device |
Pharmacovigilance Library |
1.0 |
Course branding change only. |
Course |
09/04/2025 |
Revision |
PCV05_B |
Device Safety and Vigilance: Reporting
|
Pharmaceutical; Medical Device |
Pharmacovigilance Library |
1.0 |
Course branding change only. |
Course |
09/04/2025 |
Major Update |
PS5-103169 |
Lead Poisoning
|
General Industry and Manufacturing; General Industry and Manufacturing; Construction |
Safety Catalog |
|
Global SME Review
All Slides Updated
Test
Job Aid |
Course |
09/03/2025 |