Quality Systems Training for Devicemakers

Quality Systems Training for Devicemakers

June 2011

Medical device manufacturers are required by the FDA to train personnel in FDA quality system requirements and procedures.

But, sending employees for training can be time-consuming and expensive. And it can be frustrating when an employee you’ve trained leaves you to go to work for a competitor — and you’re forced to start all over again.

But there is an easier way. Now you can train your staff yourself — for significantly less money, in your own office — with the FDA’s own training video that operates on any Windows-based personal computer.

The FDA originally videotaped these 10 training sessions — more than eight hours’ worth — to train its own staff in quality training.

Now FDAnews has brought all 10 sessions together on one convenient, affordable DVD, designed to give you the kind of high-level employee education everyone wants … with the flexibility that makes in-house training most beneficial.

With it, you can train your entire staff … or one person at a time … at their own pace … at a time that’s convenient for all … as an all-day crash course to watch the entire video, or an hour or two at a time to watch it section by section.

And, if you or staff members need a brush-up, you can easily pop in the DVD and play only those sections you need to review.

The FDAnews Quality Systems Training for Devicemakers is your best alternative to the never-ending expense of sending your staff off-site for training.

And there’s no better time to purchase it than now. Staff training has never before been this affordable. Please read on for more information.

The Quality Systems Training for Devicemakers puts you fully in control of your training. It allows you to plan sessions at times that work best for your company, that are convenient to you and your staff, and for an amount of time that fits your company’s day-to-day business schedule. You completely avoid the stress of having to plan your daily work around off-site training.

But most importantly, the Quality Systems Training for Devicemakers gives you the effective top-level training you need, while keeping its cost at a minimum.

This training program is already in use by hundreds of device manufacturers to keep their staffs fully qualified on the FDA quality system regulation. It’s great for professional trainers too.

The FDA's Quality System Regulation is the key regulation for devicemakers. Solve your training problems the easy way with the Quality Systems Training for Devicemakers — and greet the FDA examiner with confidence.

The Ten Sessions:

  • Overview
  • Scope and Management Controls
  • Documents, Records & Change Control, and I.D. & Traceability
  • Design Control
  • Material Control
  • Production & Process Control, and Facility & Equipment Control
  • Process Validation: Quality System Requirements and GHTF Guidance
  • Complaint Handling and Servicing
  • Corrective and Preventive Actions
  • FDA Export Certificates
Suggested Customers:
  • Quality Assurance/Quality Control
  • Compliance Officers
  • Consultants/Service Providers
  • Regulatory Affairs

Get Multi-user Access With A Multi-User License.
Save money with a license agreement allowing significant numbers of users access this DVD. Contact customer service for a quote or more information.

Customer Service:
Phone:  +1 (703) 538-7600 or toll free (888) 838-5578
Email:  customerservice@fdanews.com