This webinar will explain the FDA QSR requirements for acceptance activities related to medical device manufacturing. It clarifies FDA’s intent using the preamble to the regulations. We will analyze recent Warning Letters and provide tips to ensure that your acceptance activities fully complies with the regulatory requirements.
Why Should You Attend:
Acceptance activities are common in device manufacturing, but seem to cause problems for some manufacturers. These problems range from simple instances of lack of procedures or acceptance criteria to misapplication of statistical methods.
- Do you know when you can use a visual check and inspection for damage at receiving acceptance?
- Do you link supplier evaluation and selection to your receiving acceptance activities?
- Can you use product in production even if you have not fully completed the receiving inspection or tests?
- If you inspect product, do you have to record all the quantitative measurements, or can just record the inspection results?
- If you use sampling plans, can you show the Operating Characteristic (OC) curve for the plan and explain what it means?
- Does your QMS link process validation with the sampling plans to help assure you are in a state of control?
- If a customer returns product, do you need to apply receiving acceptance activities?
- When you release final product for distribution, do you know the record keeping requirements for the authorization?