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. This webinar will clear up the regulatory requirements, and help you plan effective and compliant acceptance activities. We look at the regulations and explain what they mean. In addition, we look at the QSR preamble to help clarify the intent and expectations. FDA published the QSR manual to help manufacturers implement the regulations.
The FDA`s Quality system Regulation (QSR) sets requirements for acceptance activities related to medical device manufacture. The requirements cover three acceptance areas: receiving, in process, and final. In addition, QSR has specific requirements for procedures and minimum requirements for record keeping. FDA Warning Letters frequently cite this section of the regulations; it is in the top five sections cited.
This webinar explains the regulations and provides guidance on their implementation. We cite the regulations and discuss the FDA s intent as provided in the preamble to the regulations. We explain the advice offer FDA s QSR Manual. This guidance helps manufacturers implement the regulations using explanation and sample procedures and forms. The FDA has recommended, in Warning Letters, that manufacturer s obtain a copy to help them come into full compliance.
The webinar concludes with an examination of some Warning Letters. We review some mistakes that manufacturers have made and point out ways to avoid them. We also see a few instances where a Warning Letter does not align with the guidance in the QSR Manual or the QSR preamble.
Why you should attend: Acceptance activities should be easy for device manufacturers. As one of the most frequently cited sections, however, there are issues and problems in this area of the regulations. This webinar will help you understand what you should do. By analyzing recent Warning Letters, you can learn from the mistakes of others, and ensure your acceptance activities fully comply with both good practice and the regulatory requirements.
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?
