Elsevier Business Intelligence announces the publication of a new Special Report: Why Medical Device Manufacturers’ Employee Training Programs Are Under FDA Scrutiny. Originally published in "The Silver Sheet," Vol. 13, No. 8, August 2009
Big company, small company ... you could be doing your employee training all wrong, right from the hiring process. This Special Report tells you how to do it right, ensure a quality product and stave off FDA penalties..
This detailed 30-page report includes critical information for everyone from the top quality assurance executive to training coordinators and HR chiefs to the supervisor on the floor.
Prepared by “The Silver Sheet’s” expert analysts, the report spotlights the most common mistakes companies make, and delivers the solutions directly from FDA and quality assurance experts, covering every step from the day an employee is hired to the moment the product is shipped.
This Special Report reveals:
- Why the FDA is looking more closely at employee training programs
- What authority the FDA has under the Quality Systems Regulation to hold medical device manufacturers accountable for their employee training programs
- The potential penalties for mistakes made by inadequately trained employees
- Critical components the FDA looks for in employee training programs
- How device manufacturers Thoratec, Medrad and Philips Consumer Healthcare Solutions have successfully built their employee training programs to meet FDA requirements
- How to avoid some common mistakes with employee training
How to avoid your first mistake
Top quality assurance experts have some non-traditional views concerning their manufacturing employees, and this report gets you inside their heads and their hiring processes, step by step. You'll even find out how the FDA uncovers many seemingly unrelated violations that started with the hiring process.
How do I know our training is effective?
You don't want the FDA to be the one to have to tell you. So our experts outline specific processes that successful manufacturers use and how they uncover the source of problems, from internal audits to scrupulous maintenance of training records.
When the FDA comes calling ...
When the regulators are standing in your lobby, are your employees scrambling to prepare? Find out from an executive running manufacturing of a high-risk device what his employees are told to do — and not do.
These are just some of the issues and actionable guidance included in this report. And it could only be delivered by “The Silver Sheet,” the most widely read resource for in-depth analysis of quality control and compliance issues for the device and diagnostic industries.
To purchase this special issue of “The Silver Sheet,” please click here.
To find out more about this special issue or what “The Silver Sheet” can do for you, please contact Julia Uspaskikh at j.uspaskikh@elsevier.com or 240-221-4538.
