ComplianceOnline

Basics of Writing Validation Protocols for Medical Devices

Instructor: Lawrence Spritzer
Product ID: 701099
  • Duration: 60 Min

recorded version

$249.00
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

Training CD

$500.00
One CD is for usage in one location only.
(For multiple locations contact Customer Care)
CD and Ref. material will be shipped within 15 business days

Customer Care

Fax: +1-650-963-2556

Email: customercare@complianceonline.com

Read Frequently Asked Questions

This Medical Device training will describe the information needed to write such protocols, and the basic contents of those protocols.

Description

This webinar will provide valuable assistance to all regulated companies that need to validate their manufacturing processes.

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.

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