This Design Validation webinar will explore how Design Validation must be conducted to avoid audit/inspection observations.
Why should you Attend:
Design Validation is a requirement of regulators prior to placing a product on the market. It is considered the last step of the Design Control process prior to transfer of the design to manufacturing. However, it is intimately tied to Process Validation a portion of Production Controls. Companies must assure that they are properly conducting Design Validation with products from a validated production process to avoid audit/inspection observations, and the risk of placing a volatile product on the market.
This presentation will explore how Design Validation must be conducted to avoid audit/inspection observations. We will review how Design Validation, Risk Management requirements for verification of risk control measures, and Process Validation are all linked together and must be properly performed to assure product is legally placed on the market. We will provide specific guidance on development of Validation Master Plans for projects that will help a company to meet regulatory requirements for both Design Validation and Process Validation as well as meet the ISO 14971 requirements for verification of effectiveness of risk control measures.
Areas Covered in the seminar:
- Effective validation practices lead to better product introduction and lower costs.
- Design Validation provides evidence product meets Customer Needs.
- Design Validation demonstrates Risk Control measures are effective.
- Conducting Design Validation requires a statistically valid sample size.
- Product used for Design Validation must be produced from validated processes.
- Are Clinical Trials required to complete Design Validation?
- How to formulate Validation Master Plans to meet regulatory requirements and requirements in standards.
- When is Software Validation required?
Who will benefit:
This presentation is designed to meet the needs of personnel responsible for Design Validation activities, Risk Management activities, and Process Validation activities. Validation of product and process can reduce total product costs and provide faster time to profitability.
- Design Managers
- Design Engineers
- Risk Managers
- Quality Engineers
- Process Engineers
- Design Quality Managers
Instructor Profile:
Edwin L. Bills, is the Principal Consultant for Bilanx Consulting LLC, a consulting firm that provides assistance to medical device companies in compliance with US FDA regulations, in development of Quality Management Systems and Risk Management processes. Edwin has over 20 years experience in the medical device industry and has participated in development of industry standards, including ISO 14971. In his consulting role he has assisted companies in Warning Letter responses. Edwin has also participated in training both company and FDA personnel in the Quality System Regulation and Product Risk Management.
