Process Validation Principles and Protocols for Medical Devices - Webinar By GlobalCompliancePanel November 15, 2012

Overview: The benefit of a consistent process is that the yield meets expected criteria. Firms that are able to implement such processes minimize their process rejections and therefore maximize profit.

Domestic and international regulations actually assist in this endeavor, by setting forth the requirements to assure a process is consistent, and that it yields output that is both safe and effective. These requirements are applicable to both automated and manual processes. This webinar explains the regulatory requirements for process validation, and also includes definitions and application of applicable terminology, and hints and recommendation for the more common types of process validation. Also covered will be the validation technique used for processes that are already in place.

Why You Should Attend: Compliance with process validation requirements results in cost savings and quality product. A robust process that has undergone complete validation provides a high degree of confidence that product will meet specifications. However, medical device professionals continue to struggle with process validation.

Areas Covered In the Seminar:
What is Validation?
When should it be used?
How does it differ from verification?
Validation vs. Verification: Which One?
Protocol preparation
Different types of validation
IQ, OQ, and PQ

Who will benefit: This webinar is targeted toward professionals involved in meeting FDA's Quality System Validation requirements:
Validation Specialists/Managers
Process Engineers
Manufacturing Engineers
Quality Engineers
Product/Process Development personnel
Research and Development personnel
Quality/Regulatory Personnel

Jeff Kasoff, RAC, is the Director of Quality at Byrne Medical, a leading manufacturer of endoscopy and colonoscopy devices, where he oversees the operation of the quality system. In this position, Jeff is responsible for oversight of the document control system, including maintenance of regulatory documentation. Prior to this, Jeff spent 13 years at Life-Tech, Inc. as the Director of Regulatory Affairs, where he was responsible for compliance of the corporate quality system. Jeff received his regulatory affairs certification in 1996.

Webinar By GlobalCompliancePanel

Price List:
Live : $245.00
Corporate live : $495.00
Recorded : $295.00

Phone: 800-447-9407
Fax: 302-288-6884

[email protected]
http://www.globalcompliancepanel.com

1000 N West Street | Suite 1200 | Wilmington | DE | USA | 19801

Event Link - http://bit.ly/O9rOhF