Wednesday 3rd April, 2013
10:00am to 11:30am
Overview: 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 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.
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 should you attend:
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?
Areas Covered in the Session:
The QSR Requirements for Acceptance Activities
Understanding the definition of a product
What to include in acceptance activity procedures
Understanding and stating acceptance criteria
Supplier testing as part of receiving acceptance
Contract laboratory testing as part of receiving inspection
Sampling plans and the OC curve
Analysis of Warning Letters that cover all aspects of acceptance activities
Understand the regulatory requirements for acceptance activities
Explain the relationship between supplier selection and receiving acceptance
Know the required documentation when the supplier performs the inspection and tests
State the FDA expectation for quantitative data in acceptance activity records
Explain the use of sampling plans and describe the OC curve
State the FDA expectation on using components before completing acceptance activities
Understand the record keeping requirements for acceptance activities
State the requirements to release a device for distribution, including the DMR linkage.
Who Will Benefit:
Inspection and test Managers
Dan is the President of Ombu Enterprises, LLC, a company offering training and execution in Operational Excellence, focused on analytic skills and a systems approach to operations management.
Livermore Common, Fremont, CA, 94539
Event Link - http://bit.ly/14ouYWv
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