Auditing Software Vendors
Auditing a software vendor can seem like an expensive, time-consuming, and unnecessary undertaking. However, when performed within the framework of risk-based validation approach, vendor audits can provide significant payback! This webinar shows you a practical approach.
In this free webinar, you will receive an overview of standard audit terminology, roles, methods, and processes.
Then, we'll discuss when and how to audit software vendors, so that you make efficient use of your time and resources. For example, did you know that in some instances, a phone interview can be a better approach than a visit to the vendor's site?
This webinar will address best practices, such as who to put on the audit team, how to notify the auditee of your intention to audit, and how to handle 'sticky' situations during the audit.
We'll also review FDA Warning Letters regarding software vendors, so you are aware of pitfalls to avoid when trying to maintain regulatory compliance.
And finally, we'll discuss what to do with the vendor audit results. For example, we'll show you how and when to leverage favorable audit results to reduce your testing and validation efforts.
Vendor Audit Webinar Topics:
- Fundamental audit terminology, roles and practices
- Key US and international regulatory guidelines regarding vendor audits
- Vendor audit timing and methods
- Common software vendor audit questions
- Standard practices during an audit
- Using vendor audit results in a risk based validation approach
- FDA Warning Letters regarding software vendors