Design Control and Product Validation (Design Validation)

Instructor: Edwin L Bills
Product ID: 701378
Training Level: Intermediate
  • Duration: 60 Min

recorded version

1x Person - Unlimited viewing for 6 Months
(For multiple locations contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section
Last Recorded Date: Aug-2009

Training CD / USB Drive

One CD/USB is for usage in one location only.
(For multiple locations contact Customer Care)
CD/USB and Ref. material will be shipped within 15 business days

Customer Care

Fax: +1-650-362-2367


Read Frequently Asked Questions

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.

Follow us :
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Upcoming In-person Seminars by EX-FDA OFFICIALS

Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

If you have any concern about the content of the webinar and not satisfied please contact us at below email or by call mentioning your feedback for resolution of the matter.

We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email call +1-888-717-2436 (Toll Free).

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