Live Webinar Process Validation: Principles and Protocols

01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 60 Minute

Webinar Includes : All the training handouts , certificate by the speaker ,Q/A and 60 mins Live Webinar

"Hear By Jeff Kasoff, RAC, CMQ/OE has more than 30 years in Quality and Regulatory management"

This webinar explains the regulatory requirements for process validation

Description

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.

Areas Covered

•    What is Validation?
•    When should it be used?
•    Validation vs. Verification: Which One?
•    Protocol preparation
•    Documentation of Results
•    Types of validation, and recommended use
•    IQ, OQ, and PQ
•    Common mistakes

Who will Benefit

•     Validation Specialists/Managers
•     Process Engineers
•     Manufacturing Engineers
•     Quality Engineers
•     Product/Process Development personnel
•     Research and Development personnel
•     Quality/Regulatory Personnel

Industries who can attend

This 60-minute online course is intended for professionals in the Medical Device, Biotechnology,Pharmaceutical Industry. Although not presently stated in the draft , the same guide could be used by FDA Regulated Industries personnel


Speaker Profile

Jeff Kasoff

FDA Speaker, Quality and Regulatory Consultant

Jeff Kasoff has also been primary liaison with FDA inspectors and notified body auditors, giving him first-hand experience with the most common issues surfaced by regulatory agencies. Jeff received his Regulatory Affairs Certification from RAPS, his Manager of Quality and Organizational Excellence certification from ASQ, and his Lean Black Belt from IIE.

Jeff Kasoff, RAC, CMQ/OE has more than 30 years in Quality and Regulatory management. Over that time, Jeff has implemented and overseen quality system operations and assured compliance, at all sizes of company, from start-up to more than $100 million in revenue. This multi-faceted experience makes Jeff uniquely qualified to address compliance issues across the entire range of company sizes.

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