Claude Code Training for Pharma & Life Sciences — GxP, Part 11, CSA
Kriv AI · Cybersecurity & IT
Certification per AWS Marketplace.
Evidence tier Source Confirmed · 4 captures on record
What the publisher says
As described on AWS Marketplace.
Pharma and life-sciences engineering teams are being asked to ship AI-assisted code into clinical, manufacturing, pharmacovigilance, and regulatory-submission systems — all directly under FDA, EMA, MHRA, and PMDA scrutiny. Until now, no pharma-specialized Claude Code training existed on AWS Marketplace.
The regulatory surface has expanded sharply: FDA Computer Software Assurance (CSA, Sept 2022) moved industry from CSV to risk-based CSA; FDA PCCP for SaMD (Dec 2024); 2025 draft guidance on AI/ML in drug development; ICH E6(R3) GCP finalized 2025; EU Annex 11 / 15 + GAMP 5 Second Edition set the bar. FDA BIMO, MHRA, EMA, PMDA inspections keep ALCOA+ + Part 11 at the top of every Form 483 and Warning Letter — which makes Copilot / Codeium rollouts almost universally blocked in QA + CSV review.
Show the rest of the publisher’s description (5 more lines)
Every AI coding training on AWS Marketplace today is industry-agnostic — none cover Part 11 code patterns, ALCOA+ review, CSA risk-based test generation, GAMP 5 categorization, CDISC SDTM/ADaM mapping, MedDRA/WHODrug coding, EDC integration (Medidata, Veeva Vault, Oracle Clinical One), or SaMD/PCCP patterns. Deloitte + Accenture Life Sciences run $75K–$250K+ bundled with advisory; ISPE GAMP + Veeva/Medidata certs cover platforms or compliance but not Claude Code. Kriv's E1 (healthcare), N18 (banking/FS), and N19 (insurance) prove the template; N20 completes the regulated-vertical family. N9 (Part 11 Compliance) + N12 (Clinical Trial Analytics + Part 11 Audit Trail) anchor Kriv's Part 11 credibility.
5-day curriculum. Day 1 — Foundations + secure setup: Claude on Bedrock in customer VPC; Opus 4.6 (validation-critical + MRM/traceability) / Sonnet 4.6 (1M context) / Haiku 4.5; IDE integrations; policy mapped to Part 11 + GxP SDLC + EU Annex 11 + SOC 2; validated vs non-validated isolation; CloudTrail logging. Day 2 — Core patterns: monorepo prompts; RAG for regulated reference data (SOPs, protocols, MedDRA, WHODrug, validation artifacts); multi-file refactors; Claude-authored tests; PR review with PHI/GxP tagging + ALCOA+ alignment. Day 3 — Pharma workflows: Part 11 code (audit trail via S3 Object Lock + CloudTrail; e-signature via Cognito + KMS; §11.300 controls); CDISC SDTM/ADaM/CDASH mapping; MedDRA + WHODrug coding microservice; Bedrock AE/SAE narrative drafting with mandatory human review; signal detection (EB05/PRR); protocol-deviation detection; enrollment-forecasting ML on SageMaker; EDC integration (Medidata, Veeva Vault, Oracle Clinical One); eCTD prep code; CSA risk-based test generation; IQ/OQ/PQ automation; validation evidence from code; MES/LIMS/CAPA; SaMD/PCCP patterns; GAMP 5 Cat 3/4/5. Day 4 — Security + compliance: §11.10 + §11.10(e) + §11.200; ALCOA+; CSA transition; EU Annex 11; ICH E6(R3); ICH Q9 QRM; HIPAA + GDPR Article 9; OWASP Top 10; SBOM for SaMD. Day 5 — Production rollout + ROI: phased rollout; productivity dashboard; Governance Committee charter aligned with Customer Quality; validation evidence automation; FDA BIMO readiness; capstone (IQ/OQ/PQ from existing codebase); 30-day office hours.
Hands-on labs (anonymized synthetic data): secure Bedrock + CSA audit logging; CDISC SDTM extractor; Bedrock AE narrative drafting with human-review gating; MedDRA/WHODrug coding microservice; protocol-deviation ML; EDC scaffolds; CSA risk-based test generator; IQ/OQ/PQ automation; SBOM for SaMD; capstone validation evidence package.
**Three tiers**. Executive Briefing — half-day $8K (up to 15 execs). Engineering Fundamentals — 2-day $15K (up to 20 engineers; Days 1–2 + labs). Full Enablement — 5-day $25K (Days 1–5 + capstone + 30-day office hours). Optional Per-Team Deep-Dive $10K (1-day for one squad of up to 10 — clinical ops/EDC; PV/Argus/ArisGlobal; manufacturing IT/MES/LIMS/CAPA; eCTD; SaMD/PCCP; diagnostic device). Pharma-Premium variant $10K/$18K/$30K per deal where GxP scope is heavier (private-offer quote). Training engagements are EDP-eligible — fees ($8K–$30K) count toward your AWS Enterprise Discount Program commitment (up to 25%). Contact info@kriv.ai to structure a Marketplace private offer against your EDP or PPA.
**Important disclosures.** Kriv is a member of the Anthropic Claude Partner Network (approved April 9, 2026) — partner, not an Anthropic-authorized reseller. Claude + API procured directly by Customer. No Anthropic / AWS / FDA / EMA / MHRA / PMDA / ISPE / regulator certifications (Kriv issues completion certificates only); not CLE-/CPE-/CE-accredited. Kriv is NOT a CRO or 21 CFR-regulated entity; no clinical trials, GMP, or pharmacovigilance. No “21 CFR Part 11 certification” exists. No legal/regulatory/clinical/GxP advice; no regulator representation or submissions. No guarantee of productivity, Form 483/WL avoidance, or inspection outcomes. Bedrock/Claude AE/SAE narratives, validation artifacts, and regulatory drafts are DRAFT only — QA/PV/RA human review required before filing. Anthropic API + Bedrock + travel costs separate.
Highlights
Highlighted by the publisher on AWS Marketplace.
First pharma / life-sciences Claude Code training on AWS Marketplace — 21 CFR Part 11 + ALCOA+ + FDA CSA (Sept 2022) + FDA PCCP for SaMD (Dec 2024) + ICH E6(R3) + EU Annex 11 + GAMP 5 Second Edition aligned. Claude on Amazon Bedrock in customer-controlled VPC with data residency, no training on customer inputs, and environment isolation for validated vs non-validated + GxP-data vs non-GxP-data. Every prompt-to-code interaction logged via AWS CloudTrail.
Veeva Vault / Medidata Rave / Oracle Clinical One integration patterns + CDISC SDTM / ADaM / CDASH + MedDRA / WHODrug coding microservices + GAMP 5 Category 3/4/5 + SaMD / PCCP code patterns + MES / LIMS / CAPA for manufacturing IT. Hands-on labs: CDISC SDTM extractor, Bedrock AE narrative drafting with mandatory human review, CSA risk-based test generator, IQ/OQ/PQ automation, SBOM for SaMD. Capstone: generate validation evidence package from an existing codebase.
AWS Select + Databricks + Anthropic Claude Partner Network member (April 9, 2026; partner, not an Anthropic-authorized reseller). Three tiers $8K/$15K/$25K + $10K Per-Team Deep-Dive; Pharma-Premium $10K/$18K/$30K per deal for heavier GxP scope (Pallavi discretion + Abhinav sign-off; private-offer quote). Built for large pharma, mid-pharma, emerging biotech, CROs, CMO/CDMOs, medical device (including SaMD), diagnostics. Completes the E1 / N18 / N19 / N20 regulated-vertical training family.
Agent build and provenance
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Compliance
- FedRAMPConfirmedNot listed90%, registry-checkedNo FedRAMP Marketplace entry matched this vendor's domain, checked 2026-08-27registry recordas observed 2026-08-27
Confirmed means matched to a public authoritative registry. Claimed means the vendor or its listing states it, not yet cross-checked. A framework not shown was not found in any source we hold, which is not evidence against it. Not listed means a scoped registry check found no match for this vendor's domain: a No is a scoped registry check, not a compliance judgment. Confidence bands: 95% domain-verified, 90% registry-checked, 80% self-attested, 70% weak signal. Self-attested items marked “vendor's site” are gathered from the vendor's own website and are not verified by us.
Vendor
External enrichment · as of 2026-08-29
Sources
Publisher resources
3 linksLinked repositories
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