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Safety Audits and Inspections
概要
The module takes an average of 3.75 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).
“This course provided a systematic view on Health Authority inspections which highlights FDA, EMA/MHRA inspections and how a company manages inspections!”
-Previous Participant
特集トピック
- Introduction to safety audits and inspections
- FDA inspections
- EMA and MHRA inspections
- Health Canada inspections
- Inspection findings
- Responding to an inspection
- Managing audits and inspections: Best practices for companies
参加対象
This module is designed for professionals involved in:
- Drug safety and pharmacovigilance
- Clinical research
- Biostistics
- Bioinfomatics
- Regulatory affairs
- Quality assurance
- Compliance
- Medical affairs
- Marketing
- Health and economic outcomes research
学習目的
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 Prevention Action (or CAPA) Plan
- Differentiate European Medicines Agency (EMA) and Medicines and Healthcare products Regulatory Agency (MHRA) inspections, the legal basis for European inspections, the new European guidelines on pharmacovigilance inspections, the MHRA’s risk-based approach, and possible sanctions
- Recognize Health Canada safety inspections and after-inspection activities
- 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