Program overview
| Track | Audience | Format | Duration | Outcomes |
|---|---|---|---|---|
| Leadership: AI Strategy for Directors & VPs | Execs, Directors, VPs, Product/IT leaders | Live workshops + playbooks | 2 half‑days (or 1 full‑day) | Portfolio of AI bets, governance model, KPI framework, risk & compliance guardrails |
| Staff: Practical AI for Daily Work | Scientists, analysts, medical affairs, operations, QA/RA | Hands‑on labs + templates | 3 × 2‑hour sessions | Role‑specific workflows, prompt & RAG patterns, measurable time‑savings |
Modules
- AI landscape & capability map for regulated industries
- Identifying high‑ROI use cases across R&D, PV, QA/RA, Med Affairs
- Build vs buy: fine‑tuning vs RAG vs agents
- Risk, privacy, IP & data residency considerations
- Operating model: center of excellence, guardrails, and change management
- Measurement: OKRs, value tracking, and experiment design
Deliverables
- Portfolio canvas of AI initiatives (12‑month roadmap)
- Lightweight governance & review process templates
- Vendor evaluation checklist (security/compliance)
- KPI & value dashboard examples
Modules
- Prompt fundamentals & task decomposition
- RAG 101: retrieving from SOPs, STPs, protocols, and knowledge bases
- Document QA & summarization with citations
- Data wrangling & analysis assists (CSV/Excel → insights)
- Drafting responses: med info letters, CAPA narratives, protocol outlines
- Safety: PHI handling, redaction, and approval flows
Toolkits & Templates
- Role‑based prompt libraries (R&D, QA/RA, PV, Med Affairs)
- RAG project starter (ingestion + eval harness)
- Compliance‑aware sharing & review checklist
- Productivity tracking sheet (before/after)
Privacy & PHI
HIPAA/GDPR guardrails, data minimization, redaction, and audit trails.
GxP Context
SOP alignment, change control, validation evidence for critical workflows.
Security
SSO, role‑based access, content filters, and logging patterns.
Expected outcomes
10–30% time saved
On common tasks like document prep, evidence gathering, and analysis.
Risk‑aware adoption
Teams learn safe usage patterns with clear escalation/approval flows.
Reusable assets
Prompt libraries, RAG starter, and measurement templates included.