Introduction

Parakeet Risk is planning a deep‑dive virtual session on AI‑native Third‑Party Risk Management (TPRM) for pharmaceutical organizations. The session will show how our Intelligent Compliance Agent unifies regulatory tracking, supplier risk visibility, and audit‑ready evidence generation for GMP environments and 21 CFR Part 11 controls. Note: Rx‑360 participation is pending confirmation; final date/time will be announced after we gauge interest.

Explore related resources in the meantime:

• Pharmaceutical Compliance Suite overview: Pharma Compliance and Data Integrity & GMP

• Third‑party risk foundations: TPRM for Industrial Supply Chains

Who should attend

• Compliance Officers and Quality leaders responsible for GMP and 21 CFR Part 11

• Risk Managers overseeing third‑party due diligence and ongoing monitoring

• EHS and Operations leaders aligning supplier risk with production continuity

• IT/CSV teams integrating QMS and evidence trails

Learning objectives

By the end of the session, attendees will be able to:

• Map TPRM requirements in pharma to a unified, AI‑assisted control framework

• Operationalize regulatory change tracking (FDA/EMA) with real‑time alerts and audit trails

• Automate supplier onboarding, certification tracking, and periodic reviews

• Generate, store, and retrieve evidence packages aligned to 21 CFR Part 11

• Use Rosella AI Agent for risk assessments, supplier performance insights, and gap analysis

• Quantify ROI with metrics like audit prep time saved and avoided disruption costs

Session outline (draft)

Live demo: what you’ll see

• Rosella AI Agent turning unstructured supplier and regulatory data into actionable risk scores and tasks

• Continuous Compliance for real‑time FDA/EMA tracking with evidence snapshots

• Supply Chain Resilience for a 360° supplier view: certifications, performance signals, and material traceability

• QMS‑friendly evidence workflows aligned with 21 CFR Part 11

• Optional ISO certification automation paths relevant to suppliers (e.g., ISO 9001/14001)

Demo screenshots (annotated previews)

• Screenshot 1: Supplier risk heatmap with drill‑downs to CAPAs and recent deviations (annotation: risk tiers, trend arrows, open tasks)

• Screenshot 2: Regulatory change log with FDA/EMA entries auto‑parsed by Rosella (annotation: source, impact, required actions)

• Screenshot 3: Certification tracker showing expirations, reminders, and linked SOPs (annotation: timeline, owner, evidence)

• Screenshot 4: Evidence package viewer with electronic signatures and audit trail metadata (annotation: signer, timestamp, version)

Interest form (tell us how to tailor the session)

Submit the following details using the site form on this page:

• Full name and role/title

• Company and primary manufacturing sites/regions

• Email address

• Primary focus (choose any): GMP compliance, Supplier onboarding, Ongoing monitoring, Regulatory change, QMS integration, ROI metrics

• Top 3 questions you want answered

• Preferred session format: 45‑min briefing, 60‑min deep dive, or small‑group workshop

• Time zone and preferred days/times

• Accessibility or language needs

• Optional: request a 1:1 follow‑up

Privacy note: We’ll use your responses only to schedule and customize the session. You may opt out at any time.

Coordination note: Rx‑360 participation is pending. We’ll update this page once confirmed and include any consortium‑specific agenda items.

How Parakeet Risk helps today

• Industrial‑specific AI: Rosella understands pharma‑grade risks like recalls and data integrity, turning them into prioritized workflows

• Spreadsheet synergy: Keep your Excel‑based checklists while adding automation and audit trails

• Unified risk ecosystem: Third‑party monitoring, certification management, and compliance tracking in one place with pre‑built integrations

• Real‑time ROI metrics: Track time saved and disruption avoided to demonstrate value

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