A tailored course, built for your situation
Mastering ISO 22301 for Manufacturing Leaders in Regulated Environments
Build resilient operations with documented, auditable continuity planning 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.
Operational resilience now demands documented, repeatable frameworks, not reactive fixes.
The situation this course is for
Too many continuity plans fail under audit or real disruption because they lack integration with existing quality systems and continuity accountability is siloed. Practitioners lack structured methods to scale their frameworks beyond a single site or function.
Who this is for
Manufacturing and operations leaders in FDA-regulated, GxP-aligned environments who own or influence business continuity, disaster recovery, and operational resilience planning.
Who this is not for
This is not for consultants selling generic templates, nor for IT-only DR planners without manufacturing exposure.
What you walk away with
- Produce an auditable, site-specific ISO 22301 Statement of Applicability aligned with cGMP
- Lead cross-functional BIA workshops that engage quality, supply chain, and facilities teams
- Design incident response structures that integrate with existing deviation and CAPA systems
- Document and validate recovery procedures for critical manufacturing processes
- Position yourself as the continuity reference across multiple business units
The 12 modules (with all 144 chapters)
Module 1. Foundations of ISO 22301 in Regulated Manufacturing
Understand how ISO 22301 integrates with existing quality systems in GxP environments. Learn key terminology, scope boundaries, and how to position continuity as a compliance imperative.
12 chapters in this module
- What ISO 22301 solves in manufacturing
- Core principles for GxP-regulated ops
- Mapping to FDA 21 CFR Part 211
- Continuity vs disaster recovery vs crisis management
- Roles in a site-level implementation
- Executive sponsorship drivers
- Linking to change control systems
- Integration with QMS frameworks
- Documentation hierarchy for audits
- Common missteps in pharma environments
- Assessing organizational readiness
- First 30-day action plan
Module 2. Business Impact Analysis for Manufacturing Processes
Learn how to conduct a manufacturing-specific BIA that identifies critical processes, recovery priorities, and interdependencies across facilities and supply chain.
12 chapters in this module
- Defining criticality in batch production
- Identifying single points of failure
- Engaging production supervisors in BIA
- Quantifying downtime cost per hour
- Mapping dependencies on utilities
- Assessing raw material availability risks
- Documenting regulatory exposure
- Time thresholds: MTD vs RTO vs RPO
- Handling legacy equipment dependencies
- BIA for multi-site coordination
- Validating findings with operations leads
- Output: Prioritized process register
Module 3. Risk Assessment and Threat Modeling
Apply risk frameworks to identify threats to continuity, from utility failure to cyber incidents, and prioritize mitigation based on likelihood and impact.
12 chapters in this module
- Threat categories in manufacturing
- Using ISO 22301 Annex A context
- Linking to existing FMEA data
- Cyber-physical system vulnerabilities
- Facility-specific risk registers
- Assessing supply chain threats
- Human factors in disruption
- Regulatory inspection as disruption
- Scoring risk severity consistently
- Mitigation hierarchy: avoid reduce transfer accept
- Documenting risk treatment plans
- Audit trail for risk decisions
Module 4. Developing the Business Continuity Policy
Create an enforceable policy that defines roles, escalation paths, and governance structures aligned with corporate standards.
12 chapters in this module
- Policy vs procedure vs work instruction
- Stakeholder alignment checklist
- Defining decision rights during crisis
- Integrating with corporate crisis framework
- Setting review and update cadence
- Approval workflows for multi-site ops
- Document control integration
- Policy communication plan
- Training requirements by role
- Linking to employee safety plans
- Exception handling process
- Sample policy document
Module 5. Incident Response Structure Design
Build a response structure that activates quickly, clarifies roles, and interfaces with existing emergency management systems.
12 chapters in this module
- War room activation protocols
- Defining crisis leadership roles
- Shift handover during extended outages
- Communication trees for plant staff
- Integration with fire safety teams
- External agency coordination
- Internal comms during disruption
- Timeline logging and documentation
- Decision tracking and approvals
- Response structure scalability
- Post-event review process
- Roster management system
Module 6. Recovery Strategy for Critical Manufacturing Lines
Develop strategies to recover production faster, including alternate sourcing, equipment swaps, and batch prioritization.
12 chapters in this module
- Identifying critical product families
- Defining recovery location options
- Alternate equipment validation
- Batch prioritization logic
- Raw material substitution protocols
- Cleaning and sterilization recovery
- Utility rerouting plans
- Cross-training operator teams
- Spare parts availability tracking
- Vendor dependency mapping
- Recovery time benchmarks
- Strategy validation process
Module 7. Creating the Business Continuity Plan Document
Assemble a complete, auditable plan document that meets ISO 22301 requirements and supports real crisis response.
12 chapters in this module
- Plan structure per ISO 22301
- Document version control
- Site-specific annexes
- Emergency contact lists
- Facility diagrams and evacuation routes
- Backup data storage locations
- Regulatory reporting triggers
- Integration with Deviation SOPs
- CAPA linkage during recovery
- Plan distribution and access
- Confidentiality handling
- Annual update workflow
Module 8. Exercising and Testing the Framework
Design and lead tests that validate plan effectiveness and demonstrate compliance to auditors.
12 chapters in this module
- Types of tests: table top vs full scale
- Scheduling across production cycles
- Engaging QA in test design
- Simulating GMP deviations during test
- Measuring test success metrics
- Documenting findings and gaps
- Corrective action tracking
- Test frequency per regulatory risk
- Involving external partners
- After-action review template
- Improvement backlog management
- Audit evidence package
Module 9. Training and Awareness Programs
Implement training that ensures staff at all levels understand their roles in continuity and response.
12 chapters in this module
- Role-based training modules
- Onboarding new hires into BCP
- Refresher training frequency
- Drill participation tracking
- Evaluating training effectiveness
- Microlearning for shift workers
- Supervisor-led discussion guides
- Multilingual delivery options
- Documentation of completion
- Competency assessment
- Awareness campaigns
- Engagement metrics
Module 10. Maintenance and Continuous Improvement
Establish a rhythm for keeping the plan current and improving resilience over time.
12 chapters in this module
- Change management integration
- Trigger points for plan updates
- Lessons from actual incidents
- Audit finding remediation
- Benchmarking against peer sites
- KPIs for continuity maturity
- Management review meetings
- Resource allocation for upkeep
- Updating BIA annually
- Plan version history
- Technology refresh cycles
- Improvement roadmap
Module 11. Audit and Certification Readiness
Prepare for internal and external audits with complete documentation and demonstrated compliance.
12 chapters in this module
- Internal audit checklist
- Gathering evidence for Clause 8
- Preparing for third-party certification
- Common audit findings
- Responding to non-conformities
- Document retention requirements
- Evidence of training completion
- Test result documentation
- Management review minutes
- Statement of Applicability format
- Gap analysis before formal audit
- Mock audit facilitation
Module 12. Scaling Across Sites and Functions
Extend your framework beyond a single facility to create enterprise-wide resilience with consistency and efficiency.
12 chapters in this module
- Central vs local governance
- Standardizing templates across sites
- Regional adaptations for compliance
- Knowledge sharing between facilities
- Centralized training delivery
- Cross-site audit coordination
- Enterprise reporting structure
- Budgeting for multi-site rollout
- Change control for global updates
- Leveraging center of excellence
- Measuring program-wide maturity
- Roadmap for enterprise adoption
How this maps to your situation
- New site facing ISO 22301 audit
- Post-incident review revealing gaps
- Expansion into new region with regulatory complexity
- Central team standardizing BCP across divisions
Before vs. after
Before
Continuity planning is reactive, fragmented across teams, and lacks auditable structure.
After
You lead a documented, tested, and scalable ISO 22301 framework used across manufacturing units.
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 fit around shift schedules and operational demands.
If nothing changes
Without structured continuity planning, organizations risk extended downtime, regulatory citations, and loss of stakeholder trust during disruptions.
How this compares to the alternatives
Unlike generic ISO 22301 training, this course is built specifically for manufacturing leaders in regulated environments, with templates and examples drawn from FDA-inspected facilities and aligned with cGMP and quality system expectations.
Frequently asked
Is this course relevant for non-IT aspects of business continuity?
Yes. This course focuses on manufacturing operations, supply chain, facilities, and regulatory compliance , not just IT disaster recovery.
How is the course structured?
12 modules, each containing 12 chapters (144 chapters total).
Will I receive templates I can use at my site?
Yes. Every module includes downloadable, customizable templates used in real FDA-regulated environments.
$199 one-time. Approximately 3 hours per module, designed to fit around shift schedules and operational demands..
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