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Validity : 23rd Jun'25 to 03rd Jul'25
Key Considerations in Verification & Validation of Medical Devices
- 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.
Overview of the webinar
This presentation will cover key considerations 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 cited in recent FDA 483 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.
Who should attend?
- Test Engineer
- Quality Engineer
- Verification Engineer
- Systems Engineer
- Software Tester
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. This webcast will dissect some of the FDA 483 observations related to design verification and design validation and teach you how they can be prevented. By learning from other firms mistakes and instituting a sound verification & validation strategy, along with proper verification and validation planning, these types of observations can be prevented.
Faculty - Ms.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. 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 Management, Software Systems Validation, Process Validation. Mercedes is an ASQ certified Biomedical Auditor (CBA), Software Quality Engineer (CSQE), Quality Manager (CQMa) and Quality Auditor (CQA). Mercedes is well versed in FDA and ISO regulations.