Key Considerations in Verification & Validation of Medical Devices by ComplianceOnline


									                Key Considerations in Verification & Validation of Medical Devices

                                    October 15, Friday 09:00 AM PDT | 12:00 PM EDT

Why Should You Attend:

Verification and Validation are required as part of 21 CFR § 820.30. A review of recent FDA 483 observations indicates that
a number of observations documented deficiencies in design verification and design validation. By learning from other
firm’s mistakes and instituting a sound verification & validation strategy, along with proper verification and validation
planning, these types of observations can be prevented.

There is a wide variation of how the medical device industry manages requirements. This presentation will cover a
requirements management approach consistent with the CMMi Requirements Management KPA, that helps companies
meet Design Control requirements. The presentation will show how the Requirements Management Specific Goals satisfy
Design Control requirements. Specific Goals to be reviewed are:

We will cover key considerations and best practices when performing design verification and design validation of medi-
cal devices.It is intended to give the attendees key knowledge in areas that are repeatedly cited in FDA 483s. The
presentation will cover verification and validation related observations including,

•   Failure to conduct design validation using production units or their equivalents
•   Failure of the verification testing to confirm that the design outputs meet the design input requirements
•   Failure to ensure that design testing is conducted under actual or simulated use conditions
•   Failure to maintain written design testing results

Date: October 15, Friday 2010
Time: 09:00 AM PDT | 12:00 PM EDT
Duration: 60 Min
Instructor: Mercedes Massana
Location: Your office or conference room (no need to travel!)                                               Mercedes Massana

    Register Now

Areas Covered in the Seminar:

•   How to properly plan Verification and Validation activities.
•   Verification & Validation testing throughout the product life cycle.
•   How to determine sample sizes needed for testing.
•   What is appropriate objective evidence.
•   How to perform regression analysis.
•   What is meant by Production Equivalence.
•   How do we validate test methods.
•   Special considerations for software based products.
   Who Will Benefit:

   This webinar will provide valuable assistance to medical device companies in performing verification and validation
   testing throughout the product lifecycle. The employees who will benefit include:

   • Systems engineers responsible for developing requirements
   • Software developers
   • Test Engineers
   • Quality System auditors
   • Engineering managers and personnel

  Instructor Profile:

                Mercedes Massana: is the founder and CEO of MDM Engineering Consultants, a consulting firm that provides
                engineering and quality consulting services in the medical device, biotechnology, and pharmaceutical in-
                dustries. Mercedes has over twenty-five years of experience in the Medical Device industry. Extensive
                experience in developing processes within the constraints of FDA/lSO Quality Systems. She has been
                responsible for establishing processes and leading groups of engineering in the following disciplines: Risk
                Management, Requirements Management, Verification and Validation, Process Improvements, Project Man-
                agement, Software Systems Validation, Process Validation. Mercedes is an ASQ certified Biomedical Audi-
                tor (CBA), Software Quality Engineer (CSQE), Quality Manager (CQMa) and Quality Auditor (CQA). Mercedes
                is well versed in FDA and ISO regulations.

  Registration Information:

      * Register Online. Use your American Express, Visa or MasterCard.
      * For more than one attendee get 20% off on the price of additional attendee.
     * Get your group to attend the webinar at a discounted price call +1- 650-620-3937.
     * Call +1 - 650-620-3937 or Fax your PO: 650-963-2556.
      * Mail your check to: ComplianceOnline (MetricStream, Inc), 2600 E. Bayshore Road, Palo Alto, CA 94303.

                                                                                                   This message was sent to you by:
Copyright © 2010                                                    2600 E. Bayshore Road, Palo Alto, CA 94303

To top