A tailored course, built for your situation
Mastering SOC 2 for Senior Program Leaders in Regulated Life Sciences
Deep implementation fluency to extend influence across compliance, QA, and development teams
$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.
Fragmented compliance execution across development, QA, and IT slows audit readiness and inflates program risk
Who this is for
Senior program managers in life sciences or regulated manufacturing who lead cross-functional initiatives and need to align compliance, quality, and technical teams around SOC 2 audit readiness
Who this is not for
Entry-level auditors, standalone IT security staff, or consultants without life sciences context
What you walk away with
- Precise control mappings for SOC 2 Trust Services Criteria in R&D and manufacturing environments
- Re-usable artifact templates for evidence collection across development cycles
- Stakeholder alignment playbook for QA, IT, and external auditors
- Faster audit cycle initiation through pre-built SoA drafts
- Cross-functional influence by owning the compliance integration layer
The 12 modules (with all 144 chapters)
Module 1. SOC 2 in Life Sciences Context
Ground SOC 2 applicability in drug development, lab data integrity, and GxP-aligned systems with real-world audit triggers and boundary-setting logic.
12 chapters in this module
- Regulatory overlap between GxP and SOC 2
- When SOC 2 applies in hybrid environments
- Mapping data flows in R&D systems
- Control scope for external vendor partners
- Audit trigger recognition
- Boundary definition for lab-instrument networks
- Documentation expectations by tier
- Internal vs external audit cycles
- GxP-SOC 2 control harmonization
- Change management implications
- Data residency in global trials
- Audit readiness triage framework
Module 2. Control Framework Integration
Integrate SOC 2 with existing quality and compliance frameworks across Lonza-style operations without duplication or control sprawl.
12 chapters in this module
- SOC 2 and ISO 9001 alignment
- Cross-walking ISO 13485 controls
- Mapping to internal QA checklists
- Avoiding redundant evidence collection
- Single source of truth for policies
- Control ownership matrix design
- Version control for control updates
- Audit trail integration
- Change impact on control validity
- Automated control testing paths
- Documentation lifecycle rules
- Exception handling workflows
Module 3. Control Mapping Methodology
Apply a repeatable method to map SOC 2 TSC criteria to actual systems, processes, and roles in complex development environments.
12 chapters in this module
- Criteria to system mapping
- Data access control tracing
- Logical access review frequency
- Authentication logging standards
- Backup validation frequency
- Incident response integration
- Vendor management touchpoints
- Physical access to lab systems
- Change approval workflows
- Segregation of duties in LIMS
- Audit log retention duration
- Control testing cadence design
Module 4. Evidence Generation Workflow
Build a predictable, low-effort evidence pipeline that survives auditor scrutiny and scales across programs.
12 chapters in this module
- Automated report scheduling
- Pre-audit evidence checklist
- Screenshots with context
- Timestamped access reviews
- Policy attestation cycles
- Training completion tracking
- Penetration test integration
- Vulnerability scan retention
- Backup recovery proof
- Disaster recovery test logs
- Incident response documentation
- Exception approval trails
Module 5. Stakeholder Alignment Strategy
Drive consensus across QA, IT, labs, and external partners using proven alignment frameworks tailored to regulated science environments.
12 chapters in this module
- Compliance communication cadence
- Cross-functional RACI setup
- Audit prep meeting structure
- Escalation path design
- Dispute resolution protocols
- Vendor evidence coordination
- QA sign-off sequencing
- IT security liaison role
- Regulatory affairs liaison
- External auditor Q&A prep
- Internal audit sync points
- Executive summary timing
Module 6. SoA Development Process
Develop a Statement of Applicability that’s accurate, defensible, and built to survive auditor follow-ups.
12 chapters in this module
- Scope boundary justification
- Control inclusion rationale
- Exclusion documentation standard
- Implementation depth scoring
- Control maturity assessment
- Evidence reference indexing
- Third-party assurance integration
- Attestation level definitions
- Risk rating methodology
- Control gap disclosure format
- Remediation timeline integration
- Version control for SoA
Module 7. Audit Engagement Execution
Lead preparation, evidence delivery, and follow-up cycles with confidence and minimal team disruption.
12 chapters in this module
- Pre-audit briefing packet
- Evidence delivery protocol
- Interview prep for team members
- Auditor question routing
- Real-time issue logging
- Daily audit sync meeting
- Finding classification system
- Response drafting workflow
- Evidence supplementation process
- Management response sign-off
- Post-audit debrief structure
- Lessons-learned capture
Module 8. Cross-Functional Control Ownership
Establish clear, durable ownership models that prevent compliance debt and control drift after audit cycles.
12 chapters in this module
- Control owner onboarding
- Quarterly review scheduling
- Change notification workflow
- Control update approval path
- Documentation versioning
- Retirement of obsolete controls
- Succession planning for owners
- Training for new owners
- Audit readiness reminders
- Automated control health checks
- Escalation to program lead
- Annual control refresh cycle
Module 9. Vendor Compliance Integration
Extend SOC 2 rigor to third parties with scalable review, evidence collection, and monitoring workflows.
12 chapters in this module
- Vendor risk classification
- Pre-contract compliance review
- Third-party audit report intake
- SOC 2 report review checklist
- Control gap negotiation
- Evidence request templates
- On-site assessment triggers
- Contractual compliance clauses
- Oversight meeting cadence
- Non-compliance escalation
- Subcontractor flow-down rules
- Exit audit requirements
Module 10. Continuous Compliance Automation
Design systems that maintain compliance posture between audits using monitoring and alerting patterns proven in life sciences.
12 chapters in this module
- Automated control testing
- Scheduled report generation
- Anomaly detection rules
- Access review automation
- Policy attestation bots
- Vulnerability scan integration
- Logging coverage thresholds
- Control drift alerts
- Dashboard for program leads
- Integration with Jira tickets
- Auto-ticketing for gaps
- Monthly compliance snapshot
Module 11. Remediation Workflow Design
Turn findings into action with structured, time-bound remediation that satisfies auditors and strengthens controls.
12 chapters in this module
- Finding triage matrix
- Root cause classification
- Remediation assignment rule
- Timeline setting method
- Evidence of fix collection
- Internal verification step
- Auditor re-review prep
- Lessons-learned update
- Policy update cycle
- Training refresh trigger
- Control monitoring adjustment
- Status reporting format
Module 12. Compliance Program Scaling
Replicate successful audit outcomes across programs, sites, and development phases with minimal rework.
12 chapters in this module
- Template reuse strategy
- Site onboarding playbook
- New program integration
- Audit cycle synchronization
- Centralized document repository
- Knowledge transfer session design
- Remote site support model
- Consistent terminology guide
- Global policy localization
- Language of evidence standardization
- Cross-site audit prep
- Scaling success metrics
How this maps to your situation
- Preparing for first SOC 2 audit
- Aligning QA, IT, and development teams
- Responding to auditor findings
- Scaling compliance across sites
Before vs. after
Before
Siloed compliance efforts, last-minute evidence scrambles, and misaligned expectations across QA, IT, and development teams.
After
A unified, proactive compliance workflow with reusable artifacts and clear ownership that extends your influence across functions.
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 for integration into real-world program timelines.
If nothing changes
Without a structured approach, SOC 2 readiness remains reactive, fragmented, and resource-intensive , increasing audit risk and limiting your ability to lead broader compliance initiatives.
How this compares to the alternatives
Unlike generic SOC 2 overviews, this course is built specifically for senior program leaders in life sciences , combining regulatory context, audit-proof workflows, and cross-functional alignment strategies you can apply immediately.
Frequently asked
Is this course focused on technical or managerial aspects of SOC 2?
It’s designed for program leaders , blending managerial oversight with just enough technical detail to lead teams confidently through audit cycles.
How is the course structured?
12 modules, each containing 12 chapters (144 chapters total).
Can I apply this to non-SOC 2 frameworks like ISO 27001?
Yes , the control mapping and stakeholder alignment methods transfer directly, though the course is anchored in SOC 2 for specificity.
$199 one-time. Approximately 3 hours per module, designed for integration into real-world program timelines..
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