Implementing Compliant Systems in the Cloud

Description:

In this course, you will learn how to implement compliance systems in a cloud environment to meet FDA and European regulatory requirements. We will outline from a technical perspective the cloud and the different service models available. The different deployment models and their considerations for implementation in a GMP environment. The compliance challenges related to security, data integrity, visibility and control and the risk mitigation strategies to reduce or eliminate risk associated to security, data integrity and control.

Curriculum for this course:
Introduction
Overview 1 min 21 secs
Learning objectives 2 mins 12 secs
Who should take this course? 1 min 34 secs
Course modules 1 min 36 secs
Module 1: Technical Overview of the Cloud
What is the cloud? 1 min 23 secs
Three service models 1 min 49 secs
Four deployment models 1 min 23 secs
Application criticality 2 mins 10 secs
Module 2: Challenges and Risk Factors
Challenges and risk factors associated with cloud systems 1 min 20 secs
Data and security 1 min 39 secs
Trust and reliability 2 mins 10 secs
Security risk 1 min 34 secs
Mitigation of risk 2 mins 14 secs
Module 3: Risk Mitigation Strategies for Cloud Based Systems
Risk mitigation 1 min 41 secs
Cloud components 1 min 21 secs
Cloud control 1 min 52 secs
Cloud policies for life science companies 2 mins 12 secs
Cloud policies for service providers 2 mins 10 secs
Supplier / vendor assessment 2 mins 02 secs
Service level agreements 2 mins 21 secs
Availability and performance 3 mins 01 sec
Change management 2 mins 31 secs
Quality of service 1 min 34 secs
Security 2 mins 10 secs
Business continuity 2 mins 01 secs
Personnel qualification 1 min 39 secs
Testing 1 min 49 secs
Incident reporting & management 1 min 30 secs
Documentation and information ownership 1 min 21 secs
Performance monitoring 1 min 32 secs
Alerts & escalation 1 min 32 secs
Module 4: Applying a Risk Based Validation Approach for Systems in the Cloud
Risk Based Approach 2 mins 01 sec
Avoid Duplication 2 min 10 secs
Supplier Assessment 1 min 30 secs
GxP Impact Assessment 1 min 39 secs
21 CFR Part 11 Assessment 1 min 18 secs
Risk Assessment 1 min 30 secs
Validation Plan 2 mins 51 secs
User Requirement Specification 1 min 49 secs
Installation Qualification 2 mins 14 secs
Operational Qualification 2 mins 01 secs
Performance Qualification 1 min 30 secs
Validation Summary Report 2 mins 10 secs
Conclusion 1 min 41 secs
Conclusion
Final Assessment
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