Acceptance Activities in FDA QSR â€“ Regulations and Warning Letters (Medical Device)
Venue: Online Event
|Event Date/Time: Apr 13, 2012||End Date/Time: Apr 13, 2012|
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.
Your Quality Management System (QMS) should be able to address these questions quickly and easily. If not, then your team needs to attend this webinar!
- 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?