Regulatory Challenges of Device Acceptance

PDF Edition - Regulatory Challenges of Device Acceptance

September 2013
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Will your acceptance activities pass an FDA inspection?

For device warning letters in 2012, acceptance activities, 820.80, was the fourth most frequently cited QSR section. Don’t be among the companies who will be cited this year.

Don’t risk legal fees, delays and lost time. Get this new FDAnews management report — Regulatory Challenges of Device Acceptance and help your organization quickly acquire a full understanding of all the relevant FDA regulations.

Acceptance activities were among the top warning letter citations in 2012, but too many companies gloss over acceptance activities details and get tripped up during an inspection.  FDAnews presents an acceptance activities compliance plan that will substantially improve your ability to pass inspections.

Your team will understand:

  • How to integrate acceptance activities with your overall quality system.
  • Which statistical and sampling acceptance techniques will satisfy the FDA.
  • Methodologies for linking purchasing and receiving activities to ensure adequate component quality.
  • The right way to determine if in-process acceptance is needed.
  • How final acceptance activities must conform to the device’s specifications.
  • Answers to frequently asked questions.

Why You Need this Report
The FDA requires devicemakers to implement acceptance activities when raw materials arrives, before finished product is shipped and at key points during the manufacturing process if components must be verified before use. In 2012, more than 100 companies were cited in 483s for inadequate acceptance activities. And in recent years, inadequate acceptance activities have played a key role in several high-profile recalls and warning letters.

This comprehensive report reviews recent FDA warning letters citing acceptance activities to provide a clear understanding of what went wrong and how companies can avoid these problems. Get the report to learn about:

  • Document controls, including how to make sure that approved procedures, work instructions and forms involved in acceptance activities are available at the proper points of use.
  • Purchasing controls: how to properly maintain the purchasing data for every product companies purchase or otherwise receive.
  • Receiving acceptance activities, including testing, inspecting and verifying product.
  • In-process acceptance activities, such as using “product at risk” and establishing forward traceability.
  • Final acceptance activities: how to control finished devices until release.
  • Designating individuals to perform differing levels of acceptance activities.
  • Acceptance records, including device master, quality system and history.
  • Sampling plans: using published sampling plans with a valid statistical rationale as a basis.

Ideal for All Devicemaker Teams
Those who will benefit from this report include purchasing managers, suppliers, QSR managers, product testers, plant inspection managers and all personnel involved in manufacturing, packaging, labeling, installing and servicing devices as well as training.

Regulatory Challenges of Device Acceptance is available in print or PDF format for only $397. The low price includes sampling plans, warning letter samples, FAQs and more.

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