ComplianceOnline

Understanding Acceptance Activities for Medical Devices

Instructor: Daniel O Leary
Product ID: 701636
Training Level: Intermediate to Advanced
  • Duration: 87 Min

recorded version

$299.00
1x Person - Unlimited viewing for 6 Months
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Recorded Link and Ref. material will be available in My CO Section

Training CD

$500.00
One CD is for usage in one location only.
(For multiple locations contact Customer Care)
CD and Ref. material will be shipped within 15 business days

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Fax: +1-650-963-2556

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Read Frequently Asked Questions

This Medical Device Training will help you in understanding clarity about acceptance activities regulatory requirements and how to plan effective and compliant acceptance activities. Discussion on warning letters issued.

Why Should You 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. 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. 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. The Warning Letter review follows an analysis of the regulations using the QSR preamble and the guidance from FDA’s QSR Manual. We look at the process description and usage of the document.

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

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.

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 is certified by APICS in Resource Management.

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