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

This FDA training is an introductory course conducted on-site by a senior Emergo consultant. Our consultants have extensive medical device company experience, so your employees will receive high quality FDA training tailored to the needs of your organization. Our FDA training varies in length from one to three days. The one-day class is an overview of the FDA Quality System Regulation (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.

Professional, on-site FDA training at your facility for one fixed fee, regardless of how many employees attend!

Our fee for training is based on a set fee plus expenses, providing a great value for companies needing to train three or more employees at one time. On-site training gives your employees the opportunity to ask questions (something they can't do easily in public or online classes) and allows employees to interact with one another during the training.

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

  • Overview of the US Food and Drug Administration (FDA).
  • Overview of the FDA Quality System Regulations (QSR).
  • General provisions of current Good Manufacturing Practice (cGMP).
  • Responsibility of management.
  • Conducting audits, taking corrective action and documenting results.
  • Creating design controls: input, output, validation, transfer, changes and documentation.
  • Purchasing and the evaluation of suppliers.
  • Identification and traceability of products.
  • Dealing with production and process changes.
  • Inspection, measuring and testing equipment.
  • Acceptance activities.
  • What to do with non-conforming products.
  • Corrective and Preventive Actions (CAPA).
  • Labeling, storage, distribution and installation.
  • Records and servicing of products.

Please contact us for more information on our FDA QSR training.

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