Overview

The Safety Audits and Inspections eLearning module introduces the role of audits and inspections in pharmacovigilance. It covers key regulatory authorities, including the FDA, EMA, MHRA, and Health Canada, along with common inspection findings, effective response strategies, and best practices for managing safety audits and inspections.

The module takes an average of 3 hours to complete.

This eLearning module can be purchased individually or as part of the Drug Safety eLearning Program (6 modules) or Drug Safety eLearning Bundle (7 modules).

Featured topics

- Introduction to safety audits and inspections
- FDA inspections
- EMA and MHRA inspections
- Health Canada inspections
- Inspection findings
- Responding to an inspection
- Best practices for managing audits and inspections

Who should attend?

This module is designed for professionals involved in:
- Biostatistics
- Bioinformatics
- Clinical research
- Clinical safety and pharmacovigilance
- Compliance
- Health and economic outcomes research
- Marketing
- Medical affairs
- Quality assurance
- Regulatory affairs

Learning objectives

Upon completion of this module, learners should be able to:
- Identify inspections, possible sanctions, and how a company should respond to an FDA inspection, including the Corrective and Preventive Action (CAPA) Plan
- Differentiate between the inspection processes of the European Medicines Agency (EMA), the Medicines and Healthcare products Regulatory Agency (MHRA), and Health Canada
- Recognize the legal basis for European inspections, the European pharmacovigilance inspection guidelines, the MHRA’s risk-based approach, and the possible sanctions for non-compliance
- List inspection findings common to both FDA and MHRA, and to each agency individually
- Determine best practices for the company’s management of audits and inspections

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Safety Audits and Inspections

Overview

Featured topics

Who should attend?

Learning objectives

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