Key Considerations in Verification & Validation of Medical Devices

Description

This medical device verification and validation training will dissect some of the FDA 483 observations related to design verification and design validation, and provide key information on how they can be prevented.

Objectives of the Presentation

What is Verification and Validation
What are the major differences between Verification and Validation
The relationship between software validation and design validation
How to avoid FDA 483s related to verification and validation

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, which helps companies meet Design Control requirements. The presentation will show how the Requirements Management Specific Goals satisfy Design Control requirements.

We will cover key considerations and best practices when performing design verification and design validation of medical 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
Areas Covered
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 can 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

For Registration

http://www.onlinecompliancepanel.com/webinar/MEDICAL-DEVICE-VALIDATION-501081/DEC-2015-ES-WORLDCONFERENCE

Note: Use Coupon code 1371 and get 10% off on registration.