Course Description
Formerly REGL.X407 - "Value-Added Quality Audits"
In today's dynamic business environment, effective quality audits are essential for achieving sustainable compliance while contributing to corporate objectives. This hands-on course introduces participants to the skills and knowledge required to conduct effective internal audits, while building a strong foundation in core auditing principles and techniques - including planning, executing, analyzing, and communicating audit results in terms that are meaningful to key stakeholders and top management.
Participants will also gain insights into the psychology of auditing, practice questioning techniques to uncover root causes, and learn how to present audit findings in a manner that drives corrective action and fosters management engagement. By the end of the course, participants will be prepared to elevate their organization's quality audit program to a more strategic and impactful level.
Learning Outcomes
At the conclusion of the course, you should be able to
- Explain how audits can help an organization achieve its strategic business objectives
- Provide a brief overview of the audit process
- Understand the psychology of audits
- Learn different ways of using questioning techniques to make the audits "value added"
- Understand, communicate and present non-conformances to 21 CFR 820 in a simulated audit setting
- Understand the MDSAP audit model
- Identify resources available to conduct audits to the FDA QMSR regulation
Topics Include
- Anatomy of the Audit Process
- Attributes of a Good Auditor
- Auditor Strategies
- The Communication Process
*This course may be applied to a certificate only if you are currently declared in a program.
Additional Information
AI* - This course will review AI tools and techniques for auditors to leverage throughout the audit process from planning to report writing.
Professional Credit
UCSC EXTENSION Approved by the California Board of Registered Nursing, Provider Number 13114, for 15 contact hours
Prerequisites / Skills Needed
Prerequisites:
- MEDD.X407: Quality Management Systems for Medical Devices: ISO 13485 and FDA QMSR
- Live-Online Attend via Zoom at scheduled times.
| Date | Start Time | End Time | Meeting Type | Location |
|---|---|---|---|---|
| Thu, 07-09-2026 | 6:00pm | 9:00pm | Live-Online | REMOTE |
| Thu, 07-16-2026 | 6:00pm | 9:00pm | Live-Online | REMOTE |
| Thu, 07-23-2026 | 6:00pm | 9:00pm | Live-Online | REMOTE |
| Thu, 07-30-2026 | 6:00pm | 9:00pm | Live-Online | REMOTE |
| Thu, 08-06-2026 | 6:00pm | 9:00pm | Live-Online | REMOTE |
This class is offered in an online synchronous format. Students are expected to log into this course via Canvas at the start time of scheduled meetings and participate via Zoom, for the duration of each scheduled class meeting.
To see all meeting dates, click "Full Schedule" below.
You will be granted access in Canvas to your course site and course materials approximately 24 hours prior to the published start date of the course.
|| Prerequisites:
Prerequisites / Skills Needed
This course applies to these programs: