celebrating 25 years OF EXCELLENCE

Welcome to AICCoE

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Introducing the New QACV AI Compliance Center of Excellence – Overview Mr. Robert J. Wherry, MSc, MS, CPIP Vice President, AI Compliance Innovation, QACV Consulting.

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AI COMPLIANCE CENTER OF EXCELLENCE (AI CCoE) SERVICES INCLUDE

Overview of AI in Life Sciences

trainings

Strategic training, help understand the emerging regulatory expectations.
Provide the historical context to explain the “Why?” behind regulatory requirements.
Tactical training with introduction to AI/ML and the appropriate compliance controls specifics for Quality and Compliance experts.

AUDITS

Performed for companies that are using AI/ML vendors.
Targeted specifically for vendors who develop or use AI/ML.

Systems/sops

Align AI/ML development into current best practices.
Avoid a force-fit of AI/ML development into inadequate systems.

SUBMISSIONS

Built for companies that need clear guidance on how to properly position and document AI/ML systems within medical device and pharmaceutical filings.

Expert Consultation & ADVICE

Consultation for companies that require practical, experience-based guidance to implement compliant and scalable AI/ML governance models.

AI Compliance Corner

Case studies
Monthly meetings
Articles
Evaluations