I am looking forward to speaking at the GxP Cloud Compliance Summit in Boston in September on Implementing a Lifecycle Risk Management Approach to the Cloud. I’ll be discussing some of my favorite topics:
- Best practices to harness a life cycle risk management approach to protect product quality and patient data
- What does a living risk assessment look like when key parts of your IT infrastructure is maintained by cloud service providers
- How does Q9 R1 impact functional and usage assessments around cloud applications
I am looking forward to meeting and discussing some of the critical questions in our heady embrace of the cloud.
Cloud based GxP systems have shifted in the last few years from “Something I guess we should figure out” to “Well guess we have it now” to “Well that is all I seem to have now.” And where 5 years ago it seemed we were obsessed about the fine details of Open vs Closed systems and what cloud-based applications are, we are now looking at much more mature questions around a risk based strategy that evaluates and ensures appropriate controls around Data Integrity, Privacy, and Security. Through a risk-based approach, we drive activities such as auditing, change control, qualification/validation, and oversight.
I am looking forward to having this discussion with my peers and sharing best practices and experiences. It is only though this type of event that we can grow as a professional.
I hope to see you there.
Investigations of a Dog 