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QA/RA Consulting, Auditing & Training

AI Foundations for Managers and Process Owners in Life Science Organizations

This practical course provides managers and process owners with a foundation for understanding and supporting responsible AI use in pharmaceutical and medical device organizations. Participants learn how to evaluate AI opportunities and risks, apply appropriate oversight, and assess whether AI applications are fit for purpose within regulated quality system and product life cycle processes. Through discussions, case examples, and exercises, attendees gain the knowledge needed to make informed decisions about AI without becoming technical specialists.

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Brief Overview of This Course on AI Foundations for Managers and Process Owners

SkillsLab Class ?

Class Content

In-Depth

Class Duration

2 Half-Days*

Teaching Format

Live, Instructor-Led

Delivery Options

Virtual or In Person**

Certification of Completion

Yes

Continuing Education Units (CEUs)

0.8

* SkillsLab classes delivered in-person (private or public) are full-day sessions delivered over 1 day.

** Interested in private training for your team, virtually or in-person at your facility? See more details or ask us about it!

Upcoming Classes

Upcoming AI Foundations for Managers and Process Owners

SkillsLab $1300

SkillsLab $1300

Course Code	Location	Class Begins	Class Ends	Daily Schedule	Course Delivery	Class Agenda	Registration
AFF	VIRTUAL DELIVERY (Eastern time - PM)	26 Oct 2026	27 Oct 2026	1:00PM - 5:00PM Eastern US Time	Virtual		REGISTER

GROUP DISCOUNT

Save up to

25%

Register 3 people, 4th attends free!

Free

*This offer cannot be combined with any other promotional offer(s).

Course Overview

Here's What We Cover in This Class on AI Foundations For Managers and Process Owners

This course provides a practical introduction to artificial intelligence for managers and process owners in life science organizations. Participants learn how AI is being used across quality system and product life cycle processes, how to evaluate potential opportunities and risks, and how to determine when additional controls or oversight may be needed.

Emphasis is placed on responsible AI use, risk-based decision making, and fit-for-purpose evaluation. Through examples and exercises, participants apply a practical framework for assessing AI use cases in regulated pharmaceutical and medical device environments.

Course Overview

SkillsLab Class

AI Essentials for Life Science Organizations

AI 101: What it is and how it operates
Key themes in the current AI landscape: societal, technical, frameworks and standards, regulatory
The opportunities, potential harms, and risks of AI use in life science organizations

Exercise! Describe Responsible AI in a Life Science Context

AI Use Cases in Life Science Organizations

Overview of AI capabilities
Examples of AI use cases in pharmaceutical and medical device life-cycle processes

Exercise! Assess the Opportunities, Potential Harms, and Risks for Example Use Cases

The Manager's Role in Responsible AI Use

Using AI responsibly in a regulated industry: the roles of the organization and the individual employee
The manager and process owner's role in supporting responsible AI

Exercise! Assess Your Current Readiness

Elements of Fit-for-Purpose AI in Life Cycle Processes

Using a risk-based approach
The core elements of fit-for-purpose AI
The questions managers need to ask about each element
Signals that indicate an AI tool is not or is no longer fit for purpose

Exercise! Evaluate a Proposed AI Use in a Process

What You Will Learn

At the conclusion of this training class, you will be able to

SkillsLab

Explain what responsible AI use looks like in a life science organization context.

Describe the role of the manager or process owner in supporting responsible AI use in the life science organization context.

Assess the opportunities, potential harms, and risks of AI use cases in pharmaceutical and medical device organization life-cycle processes.

Recognize when human oversight is needed, what the oversight should include, and how AI-supported decisions should remain accountable, documented, and controlled.

Apply a reusable set of fit-for-purpose elements to evaluate proposed AI uses.

Who Should Attend

for managers, supervisors, and process owners in pharmaceutical, biotechnology, and medical device organizations who may sponsor, oversee, approve, or use AI-enabled processes. It is intended for business and quality professionals who need to make informed decisions about AI use but are not AI technical specialists.

Managers and supervisors
Process owners and business process leaders
Quality and regulatory professionals
Manufacturing, operations, and engineering personnel
Research and development professionals
Project and program managers
Directors and functional leaders responsible for organizational processes and performance
Individuals involved in evaluating, approving, governing, or implementing AI-enabled processes and tools