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Privacy, Security, HIPAA & 21 CFR Part 11 for Bioinformatics | Compliance-by-Design

NTHRYS >> Services >> Academic Services >> Training Programs >> Bioinformatics Training >> Clinical & Translational Bioinformatics / Precision Medicine >> Privacy, Security, HIPAA & 21 CFR Part 11 for Bioinformatics | Compliance-by-Design

Privacy, Security, HIPAA & 21 CFR Part 11 for Bioinformatics — Hands-on

Build compliance-by-design pipelines for clinical and translational bioinformatics. This hands-on module covers HIPAA/HITECH and 21 CFR Part 11 essentials, global privacy context (GDPR/India DPDP — overview) , de-identification and consent, technical/administrative controls, computer system validation, documentation, and day-to-day compliance operations for audit readiness.

Privacy, Security, HIPAA & 21 CFR Part 11 for Bioinformatics
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Session 1
Fee: Rs 22520
Regulatory Landscape & Data Protection
  • HIPAA/HITECH essentials
  • PHI & identifiers covered entities & BAAs minimum necessary
  • 21 CFR Part 11 scope
  • e-records & e-signatures validation expectations audit trails/time stamps
  • Global privacy (overview)
  • GDPR principles India DPDP Act DPIA/TRA basics
Session 2
Fee: Rs 26720
Controls, Security Architecture & Validation
  • Access & identity
  • RBAC/ABAC MFA/SSO least privilege
  • Crypo & logging
  • TLS/at-rest encryption KMS & key rotation tamper-evident logs
  • CSV & GxP validation
  • VMP & risk-based approach IQ/OQ/PQ change control
Session 3
Fee: Rs 30920
Clinical Data Governance & Safe Analytics
  • De-identification & consent
  • Safe Harbor vs Expert limited datasets & DUAs consent management
  • Secure environments
  • segmented VPC/VNET data egress controls workspace hardening
  • Monitoring & incidents
  • SIEM & alerts IR playbooks breach notification
Session 4
Fee: Rs 36520
SOPs, Evidence & Audit Readiness
  • Documentation & training
  • policies/SOPs/WIs role-based training competency records
  • Vendors & contracts
  • BAAs & DPAs right to audit SLAs & SLOs
  • Audits & CAPA
  • checklists & evidence findings → CAPA continuous improvement


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