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.
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.
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
Quality System auditors
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 industries. 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.
Use coupon code NB5SQH8N and get 10% off on registration, Valid till Dec 31st 2015.