cGMP Cybersecurity Professional (CCGMP™) Certification by Tonex
The Certified cGMP Cybersecurity Professional (CCGMP™) certification is designed to equip professionals with the necessary skills to implement and manage cybersecurity measures in compliance with cGMP regulations. The program focuses on the integration of cybersecurity practices into the manufacturing process to protect against cyber threats, maintain product quality, and ensure patient and consumer safety.
Objectives:
- To understand the intersection of cGMP regulations and cybersecurity in the manufacturing sector.
- To develop expertise in assessing and mitigating cybersecurity risks in cGMP environments.
- To implement cybersecurity controls that comply with cGMP standards and enhance product integrity.
- To prepare for and respond to cybersecurity incidents in a cGMP-regulated setting.
Target Audience:
- Cybersecurity professionals in the pharmaceutical, biotechnology, and food manufacturing sectors.
- Quality assurance and compliance officers in cGMP-regulated industries.
- IT and security managers responsible for maintaining cGMP compliance.
- Operational technology (OT) security professionals in manufacturing environments.
Exam and Knowledge Domains
Exam Domains:
- Principles of cGMP and Cybersecurity Integration
- Risk Management and Cyber Threats in cGMP Environments
- Cybersecurity Best Practices for cGMP Compliance
- Incident Response and Recovery in cGMP Settings
- Regulatory and Compliance Requirements for cGMP and Cybersecurity
Number of Questions: 90
Type of Questions: Multiple-choice, scenario-based analysis, simulations, and case studies
Passing Grade: 75%
The CCGMP certification would aim to provide a thorough understanding of how to manage cybersecurity in the context of cGMP, emphasizing the protection of manufacturing processes and product quality. The certification process would assess candidates on their ability to integrate cybersecurity practices within cGMP guidelines, ensuring both compliance and the safety of the products manufactured.
Course Outlines:
Module 1: Fundamentals of Cybersecurity in cGMP Environment
- Overview of cGMP Regulations
- Introduction to Cybersecurity in cGMP
- Risk Management Framework in cGMP Cybersecurity
- Importance of Data Integrity in cGMP
- Key Cybersecurity Threats in cGMP Environment
- Best Practices for Secure Data Handling in cGMP Processes
Module 2: Security Policies and Procedures in cGMP
- Developing Security Policies for cGMP Compliance
- Implementing Access Control Measures
- Secure Configuration Management
- Incident Response Planning in cGMP
- Training and Awareness Programs for cGMP Cybersecurity
- Regular Security Audits and Assessments
Module 3: Secure Communication and Network Infrastructure in cGMP
- Securing Network Architecture in cGMP Environment
- Encryption Technologies for Data Protection
- Secure Remote Access Solutions
- Implementing Intrusion Detection and Prevention Systems
- Ensuring Secure Wireless Communication
- Redundancy and Disaster Recovery Planning
Module 4: Authentication and Authorization Mechanisms in cGMP
- Understanding Authentication Methods in cGMP
- Role-based Access Control (RBAC) Implementation
- Multi-factor Authentication (MFA) for Enhanced Security
- Identity Management Solutions for cGMP Systems
- Secure User Provisioning and Deprovisioning
- Continuous Monitoring of User Activities
Module 5: Data Protection and Privacy in cGMP
- Ensuring Data Confidentiality in cGMP Processes
- Secure Data Storage and Transmission
- Implementing Data Loss Prevention (DLP) Measures
- Privacy Enhancing Technologies (PETs) for cGMP
- Compliance with GDPR and Other Data Protection Regulations
- Secure Data Destruction Practices
Module 6: Emerging Technologies and Future Trends in cGMP Cybersecurity
- Blockchain Applications in cGMP Environment
- Internet of Things (IoT) Security in cGMP Processes
- Artificial Intelligence and Machine Learning for Threat Detection
- Quantum Computing and Its Implications for cGMP Cybersecurity
- Biometric Authentication in cGMP Systems
- Predictive Analytics for Proactive Cyber Defense in cGMP