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
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.
• 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