Foundations
ISOE School
ISOE School
Curriculum
Foundations
Reading a CFR citation
Resources
Regulatory landscape orientation
Resources
Risk and controls vocabulary
Resources
Courses
Blood Center Operations
Donor recruitment and screening
Resources
Collection and testing
Resources
Component processing and labeling
Resources
Storage, distribution, and hemovigilance
Resources
BECS in the pipeline
Resources
Quality System Essentials
The AABB quality system at a glance
Resources: The AABB quality system at a glance
Deviations and nonconformances
Resources: Deviations and nonconformances
CAPA: root cause to effectiveness check
Resources: CAPA — root cause to effectiveness check
Change control for regulated systems
Resources: Change control for regulated systems
Document control and records
Resources: Document control and records
Quality risk management
Resources
Internal audits and management review
Resources: Internal audits and management review
Directing the Quality Analyst
What your QA produces, and who owns it
Resources: What your QA produces, and who owns it
Reviewing deviation and CAPA write-ups
Resources: Reviewing deviation and CAPA write-ups
Escalation: what has to reach you, and how fast
Resources: Escalation criteria
Reviewing a validation package: the decision trail
Resources: Reviewing a validation package
Reviewing a vendor risk assessment: the decision trail
Resources: Reviewing a vendor risk assessment
Coaching your QA and reporting upward
Resources: Coaching your QA and reporting upward
Computerized System Validation & BECS
GAMP 5 and the V-Model
Resources
IQ, OQ, PQ, and the Traceability Matrix
Resources
BECS as a Regulated Device
Resources
QMSR, ISO 13485, and the Vendor
Resources
Part 11 for Validated Systems
Resources
Staying Validated: Changes, Patches, and Periodic Review
Resources
BECS Interfaces and Data Integrity
Resources
Data Integrity & Records
ALCOA and Data Integrity
Resources
Audit Trails and E-Signatures in Practice
Resources
Predicate Rules and Hybrid Systems
Resources
Legacy Systems and Part 11 Gaps
Resources
Retention Across Record Types
Resources
Multi-Site Governance and Donor Identification
Resources
FDA & AABB in Practice
FDA Inspection Authority and Outcomes
Resources
Warning Letters and Recalls
Resources
Filing a Biological Product Deviation Report
Resources
The AABB Assessment Process
Resources
Designing an Internal Audit Program
Resources
Mock Inspections and Presenting IT/BECS Evidence
Resources
GRC Frameworks & Risk Management
Risk Management Frameworks Side by Side
Resources
Categorize and Select Controls
Resources
Implement and Assess Controls
Resources
Authorize and Monitor
Resources
POA&Ms and CAPAs
Resources
Healthcare Security & Privacy
Information Governance in a Covered Entity
Resources
The HIPAA Privacy Rule
Resources
Security Rule Safeguards and Part 11
Resources
Breach Notification and Dual Reporting
Resources
Investigating a Healthcare Data Incident
Resources
Vendor & Third-Party Risk Management
Supplier Qualification and Risk Tiering
Resources
Reading a SOC 2 Report
Resources
Reading an ISO 27001 Certificate
Resources
Business Associate Agreements
Resources
Vendor Change Notifications and Your Own Change Control
Resources
ITSM for Regulated Blood Services
ITIL-to-QSE Crosswalk: Change and Problem
Resources
ITIL-to-QSE Crosswalk: CMDB and Continual Improvement
Resources
ITIL-to-GRC Crosswalk
Resources
Building an Inspection-Ready Service Catalog and CMDB
Resources
Translating ITSM and Risk Metrics for Executives
Resources
Presenting IT Service and Risk Performance
Resources
Foundations
Shared building blocks. Each one is taught once and linked wherever a course needs it.