FDA QSR Training (21 CFR Part 820) for Medical Device Companies

ANSWERED ON THIS PAGE:

  • Why should we train our employees on FDA QSR?
  • What will our team learn in this training?
  • What are the benefits of an exclusive on-site training?

FDA Quality System Regulation (QSR) compliance requires the full participation of everyone on your team. The FDA Investigator can show up without little to any notice, so it is important that your employees understand what they can do to help your company maintain compliance. Emergo’s FDA training is an intensive course conducted on-site by a senior Emergo consultant.

FDA training for one fixed fee, regardless of how many employees attend

Our training is available for a set fee plus expenses, providing a great value for companies training three or more employees at one time. On-site training gives your employees the opportunity to ask questions (something they cannot do easily in public or online classes) and allows employees to interact with one another during the training. Our training varies in length from one to three days.

What your team can learn in an intensive FDA QSR training class

The one-day class is an overview of the FDA QSR, while the two- or three-day training class provides more in-depth QSR training. The two- or three-day sessions can be customized to suit your company's specific needs, including:

  • Overview of the US Food and Drug Administration (FDA)
  • Overview of the FDA Quality System Regulation (QSR)
  • General provisions of current Good Manufacturing Practice (cGMP)
  • Responsibility of management
  • Conducting audits, taking corrective action and documenting results
  • Design controls including input, output, verification, validation, transfer, changes, and design history file
  • Document control and records
  • Purchasing controls and supplier evaluation
  • Product identification and traceability
  • Dealing with production and process changes
  • Inspecting, measuring, and testing equipment
  • Acceptance activities
  • What to do with non-conforming products
  • Corrective and Preventive Action (CAPA)
  • Labeling and packaging controls
  • Handling, storage, distribution, and installation
  • Servicing of products

Our consultants have extensive medical device company experience, so your employees will receive high quality FDA training tailored to the needs of your organization.

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