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Inspection and Audit Readiness Training for Medical Device Manufacturers

There is an art to effectively managing an inspection. Leveraging decades of experience from our technical experts, this experiential-based workshop is designed to show teams how to effectively prepare for external audits and inspections. Hands-on exercises, best-practice tips, “do’s and don’ts,” real-time role-play, practice, and constructive feedback prepare team members for the logistics of an audit or inspection, and instruct them on auditee behavior, site preparation activities, front room / back room set up, and documentation prep. Participants will also gain an understanding of auditor / investigator techniques so your team is prepared and, most importantly, has the confidence to effectively navigate the challenges that FDA and Notified Body audits / inspections present.

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High Level Overview of This Training Class

SkillsLab Class ?

Class Content

In-Depth

Class Duration

3 Days

Teaching Format

Live, Instructor-Led

Delivery Options

Private Team Training Only*

Certification of Completion

Yes

Continuing Education Units (CEU)

2.4

* This class is only offered privately to groups of six or more. We can conduct this class virtually or at your facility. 

Upcoming Classes

Upcoming Inspection and Audit Readiness for Medical Devices Training Courses

SkillsLab

SkillsLab

There are no public training classes scheduled right now but this class can be delivered privately to 6 or more people at any time. Ask us for details!

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

What We Cover in This FDA Inspection and Notified Body Audit Readiness Class

This course will help to prepare your firm for FDA inspections and Notified Body audits. Using an interactive, hands-on approach, you will practice applying new knowledge and skills to the process end-to-end.

Course Overview
SkillsLab Class

Overview of Inspections and Notified Body Audits

  • Understanding the process approach
  • Audit / inspection process overview
  • FDA QSIT approach to inspections
  • Evaluate your strategy

Prepare for the Inspection

  • How to manage inspections using a front-room and back-room methodology
  • Plan the logistics
  • Preparing for the inspection: Policies, procedures
  • Assembling and evaluating your introductory packet of key documents
  • Logistics of the front-room / back-room approach
  • Roles and responsibilities
  • Go-ahead and go-behind teams
  • Tips for conducting the plant tour
  • Select, vet, and prepare your teams
  • Complete the inspection prep checklist
  • Plan the inspection route
  • Preparing for Notified Body audits

Managing the Inspection

  • Receiving the investigator
  • Organizational overview presentation
  • Daily walk-through
  • Conduct a pre-inspection walk-through
  • The interviews: Scenarios for discussion
  • Role play: QSIT-based interviews
  • Effective interview communications
  • Inspection conclusion: The exit interview and 483s

Follow Up and Conclude the Inspection

  • Finalizing the inspection process: Requesting EIRs, closing CAPAs, management discussion, warning letter items
  • Responding to a Form 483 or warning letter

Preparing for a Mock Inspection

  • Facility walk-through
  • Checklist completion
  • Front-room / back-room test
  • Material preparation status
Workshop!Dry Run of the Process
What You Will Learn

What You Will Learn

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

Use an FDA preparedness checklist to ready your site for inspection

Establish and practice inspection management techniques

Identify and describe your gaps and know how to address them during the inspection

Anticipate an investigator’s next steps and respond in ways that facilitate the process

Communicate effectively with the investigator – and with your inspection team – by avoiding common communication pitfalls and applying best practices

Respond to observations or findings appropriately

Who Should Attend

Who Should Attend

  • Management
  • Internal auditors
  • QA personnel
  • QC personnel
  • Front room/back room staff
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