GMP Inspection Readiness - Interacting with the Inspector


Lesson Code: OPE-1102 (PREMIUM LESSON) Interacting with the Inspector can be a major source of problems during a GMP Inspection. Proper behaviours and understanding the types of questions that an Inspector will ask are extremely important parts of your team's success. Using the very latest in e-learning technology and a scenario-driven approach, this e-Lesson explores the types of questions that are typically asked in a GMP Inspection situation along with appropriate responses. Additionally, the behaviors that should be exhibited by anyone interacting with an inspector are also explained and illustrated within a comprehensive and immersive scenario based on recent real-world inspections. A new point scoring system lets you take part in certain key questions & interactions with the inspector, with a verdict presented at the end to let you know how well you have performed.


  • Category: GMP Inspection Readiness

Description

Using a scenario-driven approach, the types of questions that are typically asked in a GMP inspection situation are detailed along with appropriate responses. Appropriate behaviors that should be exhibited by anyone interacting with an inspector are also explained and illustrated.

Scenario description:

This e-Lesson is based on a fictional company called 'Metagen' (Biopharmaceutical Manufacturing) and you get to play the roles of several members of the company's Inspection Team as well as production and laboratory employees in order to learn the most current techniques for interacting with Inspectors.  

Skillpad can customize this e-Lesson to suit any specific Pharma, Biopharma, or Medical Device company needs - contact us to find out how!!


After taking this Lesson, you will be able to:

- Describe the purpose of a GMP Inspection

- Describe what typically happens in a GMP Inspection and who is involved

- Recognize the different types of questions an Inspector can ask in a GMP Inspection, including:

  • Open
  • Closed
  • Leading
  • Assumptive
  • Neutral
  • Repeat

- Respond appropriately to question typically asked in a GMP Inspection

- Demonstrate appropriate behaviours during a GMP Inspection