Inspection Readiness and Management Badge
Why Inspection Readiness? How many findings could have been prevented by effective inspection management? Time and time again, we find ourselves reacting instead of proactively planning so that we navigate an inspection with confidence. Now is the time change your mindset from dreading inspections, to seeing them as an opportunity to improve your products, processes and systems.
Who Should Enroll? The Inspection Readiness and Management Badge is designed for those who will conduct internal audits, external audits, and prepare for inspections conducted by global regulatory authorities.
What Will I Learn? Below, you will find each class listed with the Learning Objectives, Expert Instructors, and total course time needed to complete the program. You will gain advanced insights on engaging with regulators, establishing key roles and responsibilities, how to prepare your team, and even how to ensure you have critical inspection rooms logistically set-up for success.
Digital Badge? Once you successfully complete the on-demand program, you will be awarded a Certificate of Completion and a Digital Badge that you can share on LinkedIn!
Meet Your Expert Instructors!
The Curriculum:
Inspection Readiness Badge: 5 Classes. 17 Videos. ~6.7 hours [0.67 CEU]
INSP01: Inspection Readiness - Regulator's Authority and What to Expect
Instructors: Blaine Spangler (Baxter), David Elder (Greenleaf Health, former FDA)
Learning Objectives:
1. Obtain insight on how inspections are executed and the different types of inspections
2. Gain an understanding of the regulator’s authority during an inspection
INSP02: Inspection Readiness - Know Your Current State
Instructor: Blaine Spangler (Baxter)
Learning Objectives:
1. Why bother knowing your current state?
2. Who are the key players?
3. When is the ideal time to prepare for inspection?
4. What methods are there for knowing your current state?
5. How to Assess and Mitigate identified risks?
INSP03: Inspection Readiness and Management - What are They Looking For?
Instructor: Yenny Ocampo (Baxter)
Learning Objectives:
1. Understand the regulator’s approach to conducting inspections
2. Understand what the regulator considers important related to the ultimate safety of the patient
3. Learn agency expectations in addition to regulations
INSP04a: Inspection Readiness and Management - Setting Up and Running the Back Room
Instructor: Blaine Spangler (Baxter)
Learning Objectives:
1. Understand the purpose, function, and roles of a Back Room
2. Learn how to prepare a Back Room
3. Understand how to run a Back Room
INSP04b: Inspection Readiness and Management - Front Room Plan
Instructor: Tracey Harris (Baxter, former FDA)
Learning Objectives:
1. Understand how to prepare and run the Front Room
2. Understand key roles and responsibilities in managing an inspection
INSP04c: Inspection Readiness - Responding to the Investigator
Instructor: Tracey Harris (Baxter, former FDA)
Learning Objectives:
1. Investigator’s Approach to Inspections
2. Do’s and Don’ts during an Inspection
3. Handling inspection-related challenges
INSP05a: Inspection Readiness - Outcomes and Responses - Part 1
Instructors: David Elder (Greenleaf Health; former FDA) and Steven Niedelman (King & Spalding; former FDA)
Learning Objectives:
1. Understand Regulatory enforcement options
2. Gain an appreciation of the strategy to appropriately respond to an agency inspection
INSP05b: Inspection Readiness - Outcomes and Responses - Part 2
Instructors: David Elder (Greenleaf Health; former FDA) and Steven Niedelman (King & Spalding; former FDA)
Learning Objectives:
1. Understand additional Regulatory Enforcement Options
2. Gain an appreciation for the impact of each enforcement action
3. How best to prepare for inspections
Pricing for On-Demand Badge:
How Will You Access the Course?
All Badge Courses are on-demand and are accessed through Pathway’s Learning Management System - Canvas.
You will receive an email invitation from Canvas (notifications@instructure.com).
You will create a Canvas log-in used for all Badges you take through Pathway.
In Canvas, you will complete all classes in sequential order. After completing a quiz at the end of each class, the next class will be made available to you.
After completing your course, you will receive your Certificate of Completion, which you can share as a Digital Badge on LinkedIn!
Interested in More? Quality Operations Forum
for Year Round Learning!
If you are a Site or Corporate Quality Professional, you are invited to join our Quality Operations Forum.
You will have many opportunities throughout the year to learn from your global peers, Chief Quality Officers and experts from our industry and beyond.
The purpose of the forum is to support you in proactively implementing successful practices gained through a vibrant network of global peers collaboratively addressing contemporary and complex challenges.
60+ World Cafe and External Intelligence meetings throughout the year are included!
Questions? Please contact Michelle Rich, our Director of Corporate Programs with any questions you might have.