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Acceptance Activities in FDA QSR - Regulations and Warning Letters

Instructor: Daniel O Leary
Product ID: 702267
  • Duration: 90 Min

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Read Frequently Asked Questions

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.

Course "Acceptance Activities in FDA QSR - Regulations and Warning Letters" has been pre-approved by RAPS as eligible for up to 1.5 RAC credits towards a participant's RAC recertification upon full completion.

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?

This webinar will clear up the regulatory requirements, provide guidance on their implementation, 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 webinar concludes with 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.

Learning Objectives:

  • 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.

Areas Covered in the Seminar:

  • The QSR Requirements for Acceptance Activities
    • Procedures
    • Record keeping
    • Receiving
    • In-process
    • Final
    • Acceptance Status
  • QSR Manual
    • 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
  • Warning letters
    • Analysis of Warning Letters that cover all aspects of acceptance activities

Who Will Benefit:

This seminar is designed for people involved in production, validation, and verification activities. Attendees should understand the concepts of processes and their interactions. Knowledge of SPC and designed experiments will be useful, but is not required. People in the following roles can especially benefit from the knowledge in this webinar:

  • Quality Managers
  • Quality Professionals
  • Production Managers
  • Production Supervisors
  • Manufacturing Engineers
  • Production Engineers
  • Design Engineers
  • Process Owners
  • Purchasing Professionals
  • Inspection and test Managers

Instructor Profile:

Daniel O'Leary, 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. Dan has more than 30 years experience in quality, operations, and program management in regulated industries including aviation, defense, medical devices, and clinical labs. He has a Masters Degree in Mathematics; is an ASQ certified Biomedical Auditor, Quality Auditor, Quality Engineer, Reliability Engineer, and Six Sigma Black Belt; and holds an APICS certification in Resource Management.

Topic Background:

Acceptance activities are a fundamental part of manufacturing process flow. You need assurance that the component parts you receive are correct; that the checks you make during production can detect problems, and that the device you ship matches the DMR requirements.

The FDA wrote regulations that specify the activities to perform. 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. These are not complicated, nor are they significantly different from standard practice. They require written procedures, acceptance criteria, and records. The requirements give the manufacturer leeway in implementation.

Yet, this is one of the most frequently cited QSR sections in Warning Letters. Requirements that should be simple for device manufactures often lead to problems, an FDA 483, and eventually a Warning Letter.

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Product Reviews Write review

I enjoyed the class, it was very informative and I learned a lot especially, on procedures in place.
- Anonymous

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