Pharmaceutical Compliance Training

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Details FDA requirements under 21 CFR Part 803 for reporting device-related adverse events by manufacturers, importers, and user facilities.

Suggested For:

• Field Based Sales Professionals
• Medical Device Representatives
• Medical Science Liaisons

Covers key patient safety initiatives set by The Joint Commission, focusing on improving communication, medication safety, and reducing healthcare-associated infections.

Suggested For:

• Field Based Sales Professionals
• Medical Device Representatives
• Medical Science Liaisons

Focuses on sterile technique, surgical team roles, and patient safety based on AORN guidelines for perioperative practice.

Suggested For:

• Field Based Sales Professionals
• Medical Device Representatives
• Medical Science Liaisons

Focuses on FDA labeling requirements, including package inserts, boxed warnings, and medication guides. Reviews real-world FDA warning letters and their implications.

Suggested For:

• Compliance Officers
• Field Based Sales Professionals
• Marketing Personnel
• Regulatory Affairs
• Promotional Review Committees
• Medical Device Representatives

Covers the Sunshine Act’s reporting requirements for payments to HCPs (Section 6002) and drug sample disclosures (Section 6004).

Suggested For:

• Compliance Officers
• Compliance Teams
• Field Based Sales Professionals
• Marketing Personnel
• Legal Teams
• Transparency Reporting

This module explains U.S. pharmacovigilance systems, emphasizing adverse event (AE) reporting timelines, serious AE criteria, and FDA’s FAERS database. Participants will learn to identify AEs, handle product complaints, and comply with post-marketing surveillance requirements to avoid regulatory penalties.

Suggested For:

• Compliance Officers
• Compliance Teams
• Field Based Sales Professionals
• Medical Science Liaisons
• Medical Affairs Personnel
• Marketing Personnel
• Regulatory Affairs
• Legal Teams

Explores the PhRMA Code on Interactions with Healthcare Professionals, covering ethical guidelines for gifts, consulting agreements, speaker programs, and CME support.

Suggested For:

• Compliance Officers
• Field Based Sales Professionals
• Medical Affairs Personnel
• Marketing Personnel
• Medical Science Liaisons
• New to Pharma
• Legal Teams

This training covers PDMA rules for drug sample distribution, including practitioner validation, inventory tracking, and FDA reporting for thefts/losses.

Suggested For:

• Compliance Officers
• Compliance Teams
• Field Based Sales Professionals
• Marketing Personnel
• Sample Operations
• Regulatory Affairs
• Legal Teams

Covers principles of radiation protection, regulatory limits, monitoring, and safe handling of radioactive materials in clinical settings.

Suggested For:

• Field Based Sales Professionals
• Medical Device Representatives
• Medical Science Liaisons

Explains the FDA’s Risk Evaluation and Mitigation Strategy (REMS) program, including requirements for high-risk drugs, compliance, and post-market safety monitoring.

Suggested For:

• Compliance Officers
• Field Based Sales Professionals
• Marketing Personnel
• Legal Teams
• Regulatory Affairs

This training outlines compliant speaker program practices under the Anti-Kickback Statute and PhRMA Code. Topics include speaker selection, fair market value payments, venue/meal restrictions, and avoiding off-label discussions. Case studies covered illustrate enforcement risks.

Suggested For:

• Compliance Officers
• Compliance Teams
• Field Based Sales Professionals
• Marketing Personnel
• Legal Teams
• Transparency Reporting

Covers the Stark Law’s prohibitions on physician self-referrals for designated health services, exceptions, and penalties for non-compliance.

Suggested For:

• Compliance Officers
• Compliance Teams
• Legal Teams