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Course Fee $2,199 USD. For multiple students special prices are available. Email training@silverbulletsecurity.com for more details

Read the review by the ISPE Singpore on this training class by David Bartlett 

Core Topics

Overview

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

     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 cyber security 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.

  • What cyber security is and how it benefits QA
  • Roles and responsibilities of cyber security
  • Cyber security functions for data integrity
  • Cyber security operations and infrastructure monitoring
  • User, functional configuration specifications and cyber security
  • Overseeing qualification testing by cyber security
  • Risk acceptance and evaluation
  • Incident response and CAPA

Managed Security services 

MSS is a combination of training, engineering and monitoring services for managing risk

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

  • 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

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