Inspection Readiness Badge

Welcome to the Inpsection Readiness Badge.

You will find each class listed below with the Learning Objectives, Instructor and link to the Course Content: video, slides, note-taking worksheets.  This program is intended to prepare companies for inspections conducted by global regulatory authorities.  The expert instructors provide advanced insights on engaging with regulators, establishing key roles and responsibilities, how to prepare your people, and even how to ensure you have critical inspection rooms logistically set-up for success.  We hope you enjoy this program!

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Certificate of Completion?

To earn a Certificate of Completion:

  1. Watch the videos on this page

  2. Use the note-taking worksheets available in each class

  3. Click the "Take the Certificate of Completion Quiz" button

  4. Complete quizzes related to each video

You'll have multiple attempts to pass each quiz if needed—our goal is for you to learn, not to be penalized. Upon successful completion of the program, you will receive a Certificate of Completion.

Technical Support

If you need technical assistance, or have feedback related to these classes, please complete the following form which will be sent immediately to our Pathway Team. You will be contacted within 1 business day regarding questions you have: Technical Support Form

Course Evaluation

Please complete an evaluation of any course you take through this Corporate Membership Site. Your insight is invaluable, and will help ensure the content is accurate, up-to-date and relevant: Course Evaluation Form

Inspection Readiness Badge: 5 Classes. 17 Videos. ~6.7 hours [0.67 CEU]

Featured
INSP01: Inspection Readiness - Regulator's Authority and What to Expect
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 ​

Part 1: Access the Class —>

Part 2: Access the Class —>

INSP02: Inspection Readiness - Know Your Current State
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?​

Part 1: Access the Class —>

Part 2: Access the Class —>

INSP03: Inspection Readiness and Management - What are They Looking For?
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​

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INSP04a: Inspection Readiness and Management - Setting Up and Running the Back Room
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​

Part 1: Access the Class —>

Part 2: Access the Class —>

INSP04b: Inspection Readiness and Management - Front Room Plan
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

Part 1: Access the Class —>

Part 2: Access the Class —>

INSP04c: Inspection Readiness - Responding to the Investigator
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​

Part 1: Access the Class —>

Part 2: Access the Class —>

INSP05a: Inspection Readiness - Outcomes and Responses - Part 1
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

Part 1:Access the Class —>

Part 2:Access the Class —>

INSP05b: Inspection Readiness - Outcomes and Responses - Part 2
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​

Part 1: Access the Class —>

Part 2: Access the Class —>

Part 3: Access the Class —>

Part 4: Access the Class —>

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