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Understanding Acceptance Activities for Medical Devices

 
  March 24, 2010  
     
 


Complianceonline, Online Web Event
2010-04-23


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

 

 

 
 
Organized by: ComplianceOnline
Invited Speakers: 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.
 
Deadline for Abstracts: Call contact
 
Registration:
Online Event
EVENT INFORMATION: Contact Admin, Phone: +1-650-620-3915, Fax number: +1-650-963-2556

E-mail: admin@complianceonline.com
 
   
 
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