Pharmacovigilance Training Online
Choose from 4 GPvP Online Courses
If you need to ensure that your company is prepared for an inspection by a regulatory body, then The Pharmacovigilance Audit course will help you comply with the principles and guidelines they have set within their legislative requirements. This course will help you conduct a diagnostic overview of pharmacovigilance activities to gain a rapid understanding of the company’s current position, against the best means of practice that correspond with regulations.
The Pharmacovigilance Audit course is perfect for you if are involved in all areas of drug safety, pharmacovigilance, regulatory and quality compliance. The course covers the key components of audits and inspections; including why they are conducted, different types of approaches to audits and how to prepare for inspections.
This course delivers an introduction to the basics of pharmacovigilance & drug safety, including in-depth explanations of audits & inspections, as well as an explanation of how to prepare for a pharmacovigilance inspection. Keeping products on the market without interruption becomes more essential with the reduced pipeline of drugs in development. Successful navigation of drug safety and pharmacovigilance are keys to product longevity, consumer confidence and regulatory compliance. This module will provide you with a strong foundation of knowledge of pharmacovigilance auditing.
1. The Pharmacovigilance Audit
2. Audits & Inspections
|Audits vs Inspections|
|Types of Audits & Inspections|
|Who Can be Audited?|
3. Preparing for a Pharmacovigilance Inspection
|Preparing for a Pharmacovigilance Inspection|
|Overview of the Pharmacovigilance Audit|
|Achieving Best Practices through the Pharmacovigilance Audit|
|Pharmacovigilance Process Model|
4. Audit Items
|Audit Items - Collection|
|Audit Items - Assessment|
|Audit Items - Reporting|
|Audit Items - Analysis|
|Additional Audit Items|
5. Company Sources of Information to be Examined
6. Pharmacovigilance Checklist