Basics of Writing Validation Protocols for Medical Devices
Instructor:
Lawrence Spritzer
Product ID: 701099
- Duration: 60 Min
All equipment needed to manufacture medical devices must be validated prior to distribution and sale of the devices. Also, the process by which these devices are manufactured must also be validated. This medical device training will describe the information needed to write such protocols, and the basic contents of those protocols. This presentation will not cover the validation of software used during the manufacturing process.
Areas Covered in the seminar:- What needs to be validated.
- Why validation is necessary.
- What information is needed prior to writing a validation protocol.
- What types of protocols are needed: IQ, OQ, PQ, Gage R&R, TMV.
- Basic components of a validation protocol.
- Additional components.
Who Will Benefit:
This webinar will provide valuable assistance to all regulated companies that need to validate their manufacturing processes. The employees who will benefit include:
- End-users responsible for applications that need to be validated
- A managers and personnel
- Validation specialists
- Consultants
- Quality system auditors
Instructor Profile:
Lawrence Spritzer, Ph.D. is the founder and President of LRS Consulting, a business that specializes in the validation and development of medical devices and clinical instruments. Prior to he worked on the development and validation of automated clinical analyzers. He has written validation plans and protocols for clients, and supervised protocol execution, and written final reports.
Refund Policy
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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. On-Demand Recording purchases will not be refunded as it is available for immediate streaming. However if you are not able to view the webinar or you have any concern about the content of the webinar 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 [email protected] call +1-888-717-2436 (Toll Free).
