Design Verification and Validation
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This webinar focuses on regulatory compliance for medical devices, with a strong emphasis on verification and validation of design inputs. Gain insights into essential regulations, tracing inputs to verification/validation, and utilizing statistical techniques for effective validation.
Inadequate design control can jeopardize FDA approval and CE mark applications for medical devices. Many products face market rejection due to incomplete or improper verification and validation. Our seminar equips participants with fundamental knowledge to navigate design verification and validation concepts, ensuring implementation in their respective roles.
Design input verification and validation are pivotal stages in medical device development, providing tangible proof that the product aligns with its intended design and user needs. Without these critical steps, regulatory agencies can't ascertain a product's safety, efficacy, and adherence to design requirements.
Areas Covered in the Session :
- Overview of design control flow and were verification and validation fit in
- Basic trace from inputs to verification and validation
- Methods of verification and validation of inputs including statistics
- Writing protocols and records
- Discrepancies and deviations
- Trace matrices form inputs to outputs
Who Should Attend:
- Quality Assurance Departments
- Quality Control Departments
- Regulatory Affairs Departments
- Research and Development Departments
- Manufacturing Departments
- Engineering Departments
- Operations Departments
- Production and Product Support Personnel
- Professionals in Design, Development, Marketing or Support of regulated medical devices.
Course Director: ALAN M. GOLDEN
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Refund Policy
Cancellation by Registrant:
- Registrants may cancel their registration for any reason up to 2 business days prior to the event. A refund will be issued minus a $45 administrative fee.
- If a cancellation occurs after materials such as documents, handouts, checklists, slide deck, or recordings have been sent by Eventura, only 40% of the registration fee will be refunded.
- If the registrant fails to cancel within the stipulated time or does not attend the event, no refund will be issued. Options available to the registrant in such cases include:
- Access to a one-time recording of the event.
- A redeemable voucher.
Substitutions of attendees may be made at any time by notifying Eventura via email.
Cancellation by Eventura:
- Eventura reserves the right to cancel or reschedule an event due to insufficient registrations or unforeseen circumstances. Registrants will be notified via email prior to the event's start time unless prevented by situation beyond control.
- If an event is rescheduled, registrants will be promptly informed of the new date and their registration will be automatically transferred.
- If the new date is not suitable, registrants may choose from the following options:
- Access to a one-time recording of the webinar after the live session.
- A redeemable voucher valid for 12 months, applicable towards any future live event or past recording.
- A full refund will be issued if no new date is provided within 90 days from the originally scheduled event date.
If an event is permanently cancelled, registrants may opt for:
- A recording of the webinar, if available.
- A redeemable voucher.
- A full refund.
Eventura reserves the right to modify some topics, materials, or speakers/instructors without prior notice.
Refund Processing:
Refunds are processed within 7 business days from the receipt of the refund request. Eventura World is not liable for any penalties or expenses incurred due to an event's cancellation.
For additional information or clarification regarding our refund or cancellation policies, please contact our support team by phone or email us at support@eventura.us. Include your transaction ID, event ID, and event date in the subject of your email.