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.
Here's your solution. Surviving a Regulatory Interview: In the Facility, the latest training package from FDAnews, 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 program — which includes both video presentations and learning materials — covers 6 important topics your floor employees need to understand and be on top of:
1.How to appear confident when you're talking to an investigator and feeling on the spot and nervous.
2.What to say if you don't understand an investigator's question — or don't know its answer.
3.How to chat with an investigator without accidentally saying something that could negatively affect the investigation.
4.Why responding to a question completely, concisely and truthfully is so important.
5.How to answer questions about SOPs.
6.What to say if you make a mistake while the investigator is with you.
The program 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.
Finally, don't forget the value and ease of in-house training. Surviving a Regulatory Interview: In the Facility, 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.
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