A tailored course, built for your situation
Mastering ISO 22301 for RA Managers in Life Sciences
Build a compounding compliance practice with documented, reusable continuity frameworks.
$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
RA Manager in life sciences with ownership over business continuity compliance and cross-site implementation consistency.
Who this is not for
Individuals without direct responsibility for compliance frameworks or operational continuity programs.
What you walk away with
- Deploy ISO 22301-aligned business continuity plans with 80% less rework on subsequent rollouts
- Maintain a living library of approved test scripts and recovery procedures
- Turn audit evidence packages into repeatable templates for multi-site use
- Establish standardized reporting that compiles faster and reflects deeper control maturity
- Create version-controlled framework assets that survive personnel changes
The 12 modules (with all 144 chapters)
Module 1. Scoping ISO 22301 for Regulated Life Sciences Environments
Define organizational boundaries, critical processes, and compliance linkages specific to pharmaceutical and medical device operations.
12 chapters in this module
- Defining scope under ISO 22301 Clause 4
- Mapping critical product lines to recovery priorities
- Aligning with PIC/S and WHO GMP expectations
- Integrating with existing RA documentation frameworks
- Identifying cross-border dependencies
- Documenting regulatory overlap with DORA and DPDPA
- Establishing internal ownership thresholds
- Linking to facility master plans
- Integrating with change control systems
- Defining roles in Business Impact Analysis
- Setting review cycles for scope updates
- Creating scope sign-off templates
Module 2. Conducting Resilience Assessments in GxP Contexts
Apply risk-based methodologies to prioritize continuity efforts across labs, manufacturing, and data integrity workflows.
12 chapters in this module
- Designing BIA questionnaires for lab environments
- Scoring downtime impact on batch release
- Incorporating data backup validation results
- Assessing cold chain dependencies
- Rating supplier recovery obligations
- Classifying regulatory reporting deadlines
- Weighting patient safety impacts
- Documenting rationale for MTD determinations
- Validating BIA data with QA leads
- Linking findings to CAPA systems
- Archiving assessment versions
- Generating executive summaries
Module 3. Designing Compliant Response Structures
Establish crisis management teams with clear authority paths that satisfy both internal governance and inspector expectations.
12 chapters in this module
- Defining crisis roles under ISO 22301 Clause 8
- Mapping to RA organizational hierarchy
- Integrating with EHS emergency response
- Aligning communication protocols with regulatory affairs
- Documenting escalation matrices
- Designating inspector-facing spokespersons
- Incorporating remote site participation
- Setting decision thresholds
- Linking to incident management SOPs
- Establishing alternates and succession
- Validating structure with tabletop leads
- Publishing team rosters
Module 4. Developing Recovery Procedures for Lab and Manufacturing Sites
Create step-by-step recovery guides that maintain data integrity, environmental control, and regulatory compliance during outages.
12 chapters in this module
- Recovery sequence for stability chambers
- Cold room requalification workflows
- LIMS downtime procedures
- Chromatography system restart protocols
- Document recovery from electronic archives
- Re-establishing environmental monitoring
- Batch record reconstruction methods
- Analytical balance recalibration
- Reagent inventory verification
- Facility decontamination coordination
- Vendor equipment recovery timelines
- Recovery completion checklists
Module 5. Implementing Documented Business Continuity Plans
Assemble complete, version-controlled continuity plans that satisfy internal audits and global inspectorates.
12 chapters in this module
- Structuring the master BCP document
- Incorporating site-specific annexes
- Linking to deviation management systems
- Version control for multi-site use
- Approval workflows for plan updates
- Storage in compliance document management
- Access controls for external auditors
- Indexing by product line and facility
- Integrating with disaster recovery plans
- Creating plan summary briefings
- Testing frequency alignment
- Documenting plan maintenance triggers
Module 6. Validating Continuity Through Realistic Testing
Design and execute tests that generate credible evidence for regulators while minimizing operational disruption.
12 chapters in this module
- Selecting test type by process criticality
- Designing GMP-compliant tabletops
- Scheduling tests around batch cycles
- Involving QA and regulatory affairs
- Creating test observation forms
- Generating inspector-ready evidence
- Documenting findings in audit logs
- Linking results to CAPA systems
- Reporting uptime and recovery metrics
- Incorporating third-party findings
- Archiving test results by site
- Scheduling retests
Module 7. Aligning with Integrated Management Systems
Connect ISO 22301 outcomes to ISO 9001, ISO 14001, and ISO 45001 frameworks already active in life sciences.
12 chapters in this module
- Mapping shared clauses across standards
- Consolidating internal audit schedules
- Unifying corrective action tracking
- Integrating risk registers
- Combining management review meetings
- Streamlining document control
- Cross-referencing training records
- Harmonizing KPI reporting
- Joint certification planning
- Leveraging integrated audits
- Sharing audit findings
- Maintaining standard-specific annexes
Module 8. Maintaining Continuity Across Organizational Change
Ensure resilience knowledge persists through leadership shifts, site transfers, and system migrations.
12 chapters in this module
- Knowledge transfer protocols
- Onboarding checklists for new RA staff
- Documenting unwritten practices
- Creating video walkthroughs
- Storing rationale in version notes
- Integrating with training matrices
- Linking to HR change processes
- Updating plans after M&A
- Revalidating after ERP changes
- Preserving institutional memory
- Archiving deprecated versions
- Setting retention periods
Module 9. Reporting and Demonstrating Maturity to Leadership
Generate concise, evidence-backed reports that show progression toward higher resilience maturity.
12 chapters in this module
- Designing resilience dashboards
- Tracking test frequency vs schedule
- Measuring recovery time performance
- Benchmarking against industry standards
- Highlighting compliance readiness
- Reporting on audit findings closure
- Demonstrating cross-functional engagement
- Quantifying risk reduction trends
- Communicating improvement milestones
- Aligning with enterprise risk reports
- Presenting to senior operations
- Using maturity models
Module 10. Optimizing for Multi-Site and Global Deployment
Scale continuity frameworks across geographies while respecting local regulatory and operational differences.
12 chapters in this module
- Standardizing core elements globally
- Allowing for site-specific annexes
- Managing language and translation
- Aligning with regional regulatory bodies
- Coordinating cross-border testing
- Managing timezone challenges
- Leveraging centralized expertise
- Supporting remote facilities
- Sharing best practices
- Harmonizing reporting metrics
- Handling local inspector preferences
- Maintaining master templates
Module 11. Integrating with Supply Chain Resilience
Extend business continuity to vendors and logistics partners critical to product continuity.
12 chapters in this module
- Assessing supplier recovery capabilities
- Reviewing vendor BCPs
- Setting contractual recovery expectations
- Mapping logistics dependencies
- Validating cold chain resilience
- Monitoring supplier test results
- Linking to procurement processes
- Managing single-source risks
- Establishing alternate sourcing paths
- Incorporating force majeure clauses
- Auditing critical vendors
- Reporting supply chain risks
Module 12. Sustaining Long-Term Resilience Through Continuous Improvement
Embed lessons from incidents, audits, and changes into permanent framework upgrades.
12 chapters in this module
- Capturing post-incident learnings
- Updating plans after real events
- Integrating audit findings
- Tracking improvement actions
- Reviewing plans after regulatory updates
- Reassessing BIA after product changes
- Updating for new facility validation
- Incorporating lessons from tests
- Benchmarking against evolving standards
- Adopting emerging best practices
- Engaging with industry forums
- Planning for next certification cycle
How this maps to your situation
- When launching a new GMP site
- During preparation for regulatory inspection
- Following organizational restructuring
- Before monsoon or disaster-prone seasons
Before vs. after
Before
Each continuity project starts from scratch, with inconsistent documentation and limited reuse across sites.
After
Every delivery builds on a living library of proven frameworks, reducing effort and increasing maturity with each cycle.
What's included with your purchase
- 12 modules with 12 chapters each (144 chapters total)
- 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 active projects.
If nothing changes
Without a compounding approach, each new site or audit requires rebuilding foundational work, leading to inconsistent outcomes and missed opportunities for leadership recognition.
How this compares to the alternatives
Unlike generic ISO 22301 training, this course is tailored to RA Managers in life sciences, with real-world examples from GxP environments, regulatory alignment, and tools for creating compounding assets.
Frequently asked
Who is this course for?
RA Managers and compliance professionals in life sciences responsible for business continuity and operational resilience.
How is the course structured?
12 modules, each containing 12 chapters (144 chapters total).
Does this course cover regional regulations?
Yes, it includes alignment with DPDPA the current cycle, RBI Master Directions, and SEBI CSCRF where relevant to continuity planning.
$199 one-time. Approximately 3 hours per module, designed to be completed alongside active projects..
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