DVD - Surviving an FDA Inspection Interview

October 2014
Have you ever wanted to take your employees inside an FDA inspection interview to show them exactly what can go wrong? Now you can with the two-part Surviving an FDA Inspection Interview video presentation.

Part 1: In the Interview
Sitting across the table from a regulatory inspector is one of your employees’ most nerve-wracking challenges.

Even experienced employees can forget how to act in the presence of an investigator, and the consequences can be devastating. Now there’s help.

This time-tested training video will let you walk your employees through the scenarios that can take an inspection off-track — and show them the right way to handle the situations investigators will throw at them.

The instructional guide and video create a powerful, hour-long training event showing employees the types of questions and tactics they’ll face during an inspection, and gives them the confidence to respond correctly.

The Key Issues Covered:

  • How to respond to a question when they don’t know or are unsure of the answer.
  • How to handle a lull or gap in the conversation.
  • How to communicate confidence with words and body language.
  • How to respond to a question completely and concisely.
  • How to respond when they don’t understand the question or the question is too broad.

Part 2: In the Facility
FDA investigators have every right to ask questions of plant-level employees during their walk-throughs. All too often, these are the workers who might flub their answers because they're under-trained.

In the Facility is designed especially to help you train your lower level, non-SME staff on how to deal with FDA investigators.

In just one hour, this training package — which includes both video presentations and learning materials — covers 6 important topics your floor employees need to understand and be on top of:

  • How to appear confident when you're talking to an investigator and feeling on the spot and nervous.
  • What to say if you don't understand an investigator's question — or don't know its answer.
  • How to chat with an investigator without accidentally saying something that could negatively affect the investigation.
  • Why responding to a question completely, concisely and truthfully is so important.
  • How to answer questions about SOPs.
  • What to say if you make a mistake while the investigator is with you.

The video features dramatized investigation scenarios, so your staffers can see examples of the right — and wrong — ways to respond to investigators and their questions. By the end of the session, you can be sure that your employees will be ready for any questions investigators may throw at them.

Don't forget the value and ease of in-house DVD training. Surviving an FDA Inspection Interview training set is designed for group training but can also be used to teach individuals who are new to the job or in need of a refresher.

Best of all, with video training, you can conduct sessions at times that are convenient to your company, you and your staff — and forget about the high cost of off-site training and travel, and the stress of having to rearrange your work schedule around being away.

Order Your Copy Today!




Available Formats

DVD — $749
eLearning — $1,297

Click Here for the eLearning Product Specs

DVD program package includes:

  • Running time: 30 minutes
  • Leader's Guide
  • Interview Issues Worksheet and Answer Key
  • Assessment and Answer Key

(Add $10 shipping and handling per DVD/CD for DVD/CDs shipped to the US, or $35 per DVD/CD for DVD/CDs shipped elsewhere. VA residents, please add 6 percent sales tax.)

Meet the Producer
GMPTraining.com is a leading producer of instructional materials for manufacturers that must keep up with FDA requirements.

Part 1: In the Interview

Part 2: In the Facility