Training Course Syllabus:

Key Considerations in Verification & Validation of Medical Devices Webinar

Description:

This webinar will discuss developing procedures for validating applications that use Excel; produce procedures for development and maintenance of the Excel applications; Standard Operating Procedures for step-by-step activities; measure quality and demonstrate compliance to regulatory and other business requirements; and produce necessary validation records.

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.

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

Seminar Summary:

This webinar will cite what are the key considerations in medical device design and validation that can help prevent FDA 483s. (see full course description)

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