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 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.
