SBS 101

SBS 101

Training

SBS 101: Cyber Security for Data Integrity and Quality Risk Management

Overview

SBS 101: Cyber Security for Data Integrity and Quality Risk Management is designed for the QA professional and assists them on the understanding of how information security fits into governance for the QMS and its application within the CSV process for GxP systems using GAMP 5. The course goals are to ensure students have a firm grasp on what cybersecurity is, regulations and standards that govern its activities, the role it plays within an enterprise and their responsibility for managing its activities during the CSV process.

Core Areas

1. What cyber security is and how it benefits QA
2. Roles and responsibilities of cyber security
3. Cyber security functions for data integrity
4. Cyber security operations and infrastructure monitoring
5. User, functional configuration specifications and cyber security
6. Overseeing qualification testing by cyber security
7. Risk acceptance and evaluation
8. Incident response and CAPA

The course is broken down into 6 modules: (2 modules per day)

Module 1: Introduction to Cybersecurity
Module 2: Information Security Standards and Regulations
Module 3: Securing the Architecture
Module 4: GAMP 5 Information Security Requirements
Module 5: QMS Governance and the ISMS
Module 6: Incorporating Information Security to the CSV Process

Scheduled Classes