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SEC9449 Mastering CIS Controls for Quality Assurance Leaders in Biopharma Compliance

$199.00
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A tailored course, built for your situation

Mastering CIS Controls for Quality Assurance Leaders in Biopharma Compliance

Build repeatable, auditable security practices that stand up to regulatory scrutiny without escalation

$199 one-time
24-hour access provisioning 30-day money-back guarantee Hand-built implementation playbook
12 modules. 12 chapters per module. 144 chapters total.
12 modules, each with 12 chapters (144 chapters total), text-based, plus downloadable templates and a hand-built implementation playbook delivered alongside course access.

Who this is for

Senior Quality Assurance Specialist in biopharmaceutical manufacturing with compliance and audit experience, working across regulated production environments and seeking to expand influence into security control ownership

Who this is not for

Entry-level auditors, IT generalists without compliance exposure, or professionals outside regulated life sciences environments

What you walk away with

  • Own the approval of CIS Controls implementation plans without escalation
  • Document defensible rationale for control exceptions in audit-facing materials
  • Map technical configurations to regulatory expectations across GxP and cybersecurity frameworks
  • Pre-clear vendor tooling selections within established security baselines
  • Produce reusable control implementation playbooks that survive team changes

The 12 modules (with all 144 chapters)

Module 1. CIS Controls Overview in Regulated Environments
Understand how CIS Controls align with GxP, ISO 13485, and data integrity expectations in biopharma. Learn where security and quality compliance converge.
12 chapters in this module
  1. What CIS Controls are
  2. Regulatory drivers for adoption
  3. Overlap with GxP data integrity
  4. Security in sterile manufacturing
  5. Audit expectations by control
  6. Control ownership models
  7. Mapping to internal policies
  8. Documentation standards
  9. Review cycles and cadence
  10. Change control integration
  11. Vendor alignment requirements
  12. Escalation thresholds
Module 2. Control 1: Inventory and Device Management
Implement rigorous asset tracking for production systems with automated validation workflows and audit-ready records.
12 chapters in this module
  1. Asset tagging in clean rooms
  2. Automated discovery tools
  3. Validation of inventory data
  4. Decommissioning workflows
  5. Audit trail requirements
  6. Integration with SAP EHS
  7. Device classification schema
  8. Ownership assignment
  9. Mobile device inclusion
  10. Network segmentation rules
  11. Exception logging
  12. Quarterly review process
Module 3. Control 2: Software Inventory and Management
Establish approved software lists and patch compliance for GxP systems, including deviation handling.
12 chapters in this module
  1. Approved software master list
  2. Whitelisting GxP applications
  3. Patch compliance timelines
  4. Validation of updates
  5. Deviation documentation
  6. Change control linkage
  7. Vendor software review
  8. End-of-life tracking
  9. User privilege rules
  10. Remote access controls
  11. Audit trail retention
  12. Review frequency standards
Module 4. Control 3: Secure Configurations for Hardware and Software
Define and enforce secure baselines for production systems with zero drift.
12 chapters in this module
  1. Baseline configuration templates
  2. GxP system hardening
  3. Configuration drift detection
  4. Automated compliance checks
  5. Remediation workflows
  6. Validation of fixes
  7. Change freeze periods
  8. Documentation standards
  9. Review by QA team
  10. Integration with Jira
  11. Exception handling
  12. Audit readiness checks
Module 5. Control 4: Continuous Vulnerability Management
Run vulnerability scans in production environments without disrupting operations.
12 chapters in this module
  1. Scan scheduling around batches
  2. Asset exclusion rules
  3. Criticality scoring
  4. Remediation SLAs
  5. Change control linkage
  6. Validation requirements
  7. Vendor patch coordination
  8. False positive handling
  9. Reporting to QA leads
  10. Integration with ServiceNow
  11. Escalation paths
  12. Quarterly audit prep
Module 6. Control 5: Controlled Use of Administrative Privileges
Manage admin access in regulated systems with time-bound approvals and logging.
12 chapters in this module
  1. Admin access policy
  2. Time-bound approvals
  3. Just-in-time access
  4. Logging requirements
  5. Review frequency
  6. Segregation of duties
  7. Break-glass procedures
  8. Emergency access logs
  9. Integration with SAP
  10. Audit trail retention
  11. Exception documentation
  12. Quarterly access review
Module 7. Control 6: Maintenance, Monitoring, and Analysis of Logs
Ensure log integrity and retention for audit and investigation purposes.
12 chapters in this module
  1. Log retention policy
  2. Centralized logging
  3. Immutable storage
  4. Access controls
  5. Log review frequency
  6. Incident correlation
  7. Integration with SIEM
  8. GxP system coverage
  9. Audit trail validation
  10. Retention by regulation
  11. Chain of custody
  12. Pre-audit checks
Module 8. Control 7: Email and Web Browser Protections
Secure corporate endpoints used in compliance-critical roles.
12 chapters in this module
  1. Browser hardening
  2. Email filtering rules
  3. Phishing simulation
  4. User training frequency
  5. Link scanning
  6. Attachment controls
  7. Domain-based filtering
  8. Quarantine procedures
  9. Reporting mechanisms
  10. Incident follow-up
  11. Audit trail capture
  12. Policy exception handling
Module 9. Control 8: Malware Defenses
Deploy endpoint protection in production environments without interference.
12 chapters in this module
  1. Antivirus selection
  2. Whitelisting exceptions
  3. Signature update frequency
  4. Real-time scanning
  5. Quarantine workflows
  6. False positive handling
  7. Validation requirements
  8. Integration with AD
  9. Incident reporting
  10. Monthly review
  11. Patch compatibility
  12. Audit readiness
Module 10. Control 9: Limitation and Control of Network Ports
Enforce network segmentation in manufacturing zones with documented exceptions.
12 chapters in this module
  1. Port usage inventory
  2. Firewall rule standards
  3. Segmentation policies
  4. Exception approval process
  5. Documentation requirements
  6. Review frequency
  7. Integration with network teams
  8. Change control linkage
  9. Audit trail capture
  10. Drift detection
  11. Remediation SLAs
  12. Pre-audit validation
Module 11. Control 10: Data Recovery and Backup
Ensure GxP data is recoverable with validated backup processes.
12 chapters in this module
  1. Backup frequency
  2. Validation of restores
  3. Retention periods
  4. Offsite storage
  5. Encryption standards
  6. Access controls
  7. Test frequency
  8. Incident recovery
  9. Documentation
  10. Change control
  11. Audit trail
  12. Pre-audit checks
Module 12. Control Implementation Playbook Integration
Assemble a living, reusable playbook for ongoing CIS Controls execution and audit readiness.
12 chapters in this module
  1. Playbook structure
  2. Template integration
  3. Ownership assignment
  4. Version control
  5. Change management
  6. Training integration
  7. Audit preparation
  8. Stakeholder review
  9. Continuous improvement
  10. Cross-functional alignment
  11. Success metrics
  12. Leadership reporting

How this maps to your situation

  • New security control rollout
  • Pre-audit preparation
  • Vendor tool selection
  • Cross-functional compliance alignment

Before vs. after

Before
Security control decisions require senior review and cross-functional alignment delays implementation
After
You own the sign-off on CIS Controls implementation plans and drive audit-ready outcomes independently

What's included with your purchase

  • 12 modules with 12 chapters each (144 chapters)
  • Downloadable templates and worked examples for every module
  • Hand-built implementation playbook delivered alongside course access
  • 30-day money-back guarantee

Delivery and format

  • Course and learning environment access provisioned within 24 hours of purchase
  • Hand-built implementation playbook delivered alongside course access

Format: Text-based modules and chapters in the Art of Service learning environment, plus downloadable templates and worked examples for every chapter, plus the hand-built implementation playbook delivered alongside course access.

Time investment: Approximately 3 hours per module, designed to be completed alongside regular work cycles.

How this compares to the alternatives

Unlike generic cybersecurity courses, this program is tailored to biopharma QA professionals with GxP and regulatory audit experience, focusing on actionable control ownership rather than theoretical frameworks.

Frequently asked

How is the course structured?
12 modules, each containing 12 chapters (144 chapters total).
Is this relevant if I’m not in IT?
Yes. The course is designed for QA and compliance professionals who need to own security controls in regulated environments.
Can I apply this to ISO 27001 or SOC 2?
Yes. CIS Controls map directly to both frameworks, and the templates support cross-standard implementation.
$199 one-time. Approximately 3 hours per module, designed to be completed alongside regular work cycles..

Within 24 hours your account in the learning environment is provisioned and the tailored implementation playbook is delivered alongside it.

30-day money-back guarantee· 144 chapters· Hand-built playbook included· Account access within 24 hours
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