Course curriculum

  • 1

    Introduction

    • What is Compliance?

    • ALCOA+

    • ALCOA + for Data Integrity
  • 2

    Pharma Compliance

    • GAMP 5 Concept

    • GAMP in Pharma Quality System

    • Implementing GAMP 5

    • 21 CFR Part 11

    • Implementing 21 CFR Part 11

    • GAMP 5 V Model Vs 21 CFR Part 11
  • 3

    Quality Standards

    • All About Quality

    • ISO 9001:2015 Quality management systems

    • ISO/IEC 27001
  • 4

    Infrastructure Security

    • Intrusion Detection System (IDS)

    • Roambee's Approach Towards Intrusion Detection

    • Penetration Testing

    • Steps of Penetration Testing Method

    • Vulnerability Assessment

    • Roambee's Vulnerability Assessment & Penetration Testing Report - Q4 2020

    • Roambee's Vulnerability Assessment & Penetration Testing Report - Q1 2021
  • 5

    Data Privacy

    • General Data Protection Regulation (GDPR)

    • GDPR and customer contracts

    • Data Privacy clauses in Roambee's Customer Agreement

    • Data Privacy for Employees
  • 6

    OWASP - Open Web Application Security Project

    • What is OWASP?

    • Injection

    • Broken Authentication

    • Sensitive Data Exposure

    • XML External Entities (XXE)

    • Broken Access Control

    • Security Misconfigurations

    • Cross-Site Scripting (XSS)

    • Insecure Deserialization

    • Using Components with Known Vulnerabilities

    • Insufficient Logging and Monitoring
  • 7

    Device Certifications

    • NIST Cybersecurity Framework V1.1

    • ATEX Certification