Process Validation – Principles and Protocols
03:00 PM ET | 12:00 PM PT | 04:00 PM CT Duration 60 Minutes
Webinar Includes : All the training handouts , certificate ,Q/A and 60 mins Live Webinar
"Jeff Kasoff, RAC, CMQ/OE, LBB, is the Principal at Lean to Quality, LLC. He has more than 30 years in Quality and Regulatory management"
Definitions and application of applicable terminology
This validation training will set forth the regulatory requirements for process validation, and will also include definitions and application of applicable terminology, and hints and recommendations for the more common types of process validation.
Why Should you Attend
It is the goal of every manufacturing firm to maximize profit. This is often accomplished by process automation. Domestic and international regulations contain the requirements to verify that the process yields output that is both safe and effective, and meets all requirements. These requirements are also applicable to manual, "un-automated" processes. This webinar will set forth the regulatory requirements for process validation, and will also include definitions and application of applicable terminology, and hints and recommendations for the more common types of process validation. These recommendations will address the challenges most commonly experienced during 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?
• Different types of validation: Advance, retrospective, and concurrent
• Protocol preparation
• Different types of validation
• IQ, OQ, and PQ
• Case studies and examples
Who will Benefit
This webinar will provide valuable assistance to all companies that incorporate processes into their manufacturing, testing, or inspection processes. The employees who will benefit include:
• R&D personnel and management
• Process and Quality Engineers
• QA management
• Regulatory management
• Quality system auditors
Industries who can attend
This 60-minute online course is intended for professionals in the Pharmaceutical, Clinical Data Management SaaS companies, and medical device companies . Although not presently stated in the draft , the same guide could be used by FDA Regulated Industries personnel.