Risk-Based Approach to Software Quality Validation
In the years since the FDA published Pharmaceutical cGMPs for the 21st Century – A Risk Based Approach many organizations have adopted the vision of implementing practical, risk-based software validation methods. However, often the next step – implementing the vision – is a very big one. The objective of this free webinar is to get you started!
In this session, you will begin by reviewing the standard terminology of software validation and risk management. Then, to provide a solid foundation, you will learn the fundamentals, as well as the principles from recognized standards, such as GAMP and PIC/S.
Once you have a risk management framework, we'll move on to practical approaches for identifying, evaluating and classifying the quality risks associated with software. Then we'll review many useable examples of how and where to apply the risk classification to both improve the quality of your software and reduce the amount of unnecessary validation work while maintaining compliance with regulator's expectations.
We'll also show you how to apply risk management concepts to SOPs, such as system security, incident management, and user training.
And finally, we'll conclude the webinar with examples of FDA Warning Letters regarding risk management, so you have examples of 'what not to do'.
Risk Based Validation Webinar Topics
- Risk identification and assessment
- Application of risk concepts to validation deliverables, testing, and documentation
- Application of risk concepts within the software quality procedures (SOPs) used throughout a system's life cycle
- Standard approaches to risk from GAMP and PIC/S
- Most frequently inspected systems and software quality topics. (indicator of FDA perspective on risk)
- Review of FDA Warning Letters regarding application of risk concepts in software validation
- Fundamental software validation and risk management terminology
- Key US and international regulatory guidelines regarding risk based approaches to quality assurance and validation