Course offering number:1004-704
Course ID:
2394
Updates on Process Validation for Medical Devices…New Approaches and Practice
In Conjunction with Medical Device Summit
Pre-recorded Course
AN ON-DEMAND ONLINE TRAINING FORMAT
Who Should Attend
This online training course is intended for managers, supervisors, engineers, chemists, scientists, technicians and formulators working within the
Medical Device Industry. It will also be valuable to documentation specialists, auditors and those in regulatory affairs. Personnel from the
following departments will find the course beneficial:
• Research and Development
• Quality Assurance and Control
• Manufacturing/Operations
• Facilities
• Finance
• IT
• Audit
• Training
• Technical Support
This training will also benefit suppliers of equipment and services to the medical device industry.
Description
In recent years, the FDA has placed intense focus on Process Validation. This 90-minute, accredited training course will examine how we have
reached the present validation environment and will give you a means for survival. It will provide a step-by-step guide to planning and preparing
for process validation, and includes a discussion of how to write validation protocols, handle deviations, report validation results and “maintain
the validated state.” The course provides a guide on how to manage the validation process efficiently and pragmatically. Further, this course
provides “content understanding” so important for auditing validation activities as required in today's FDA regulated industry environment.
Module 1: Major revisions:
• How did we reach the present validation
environment?
• Why do I need to validate processes?
• What is process validation?
• Does every process need to be validated?
Module 2: Post market surveillance:
• The Validation Master Plan
• Basics of validation
• What are all the letters in the alphabet
soup?
• Protocol Basics and Content
Module 3: International harmonization:
• Handling Deviations
• Validation Reports
• Proper validation timing
• Maintaining the validated state
• Auditing Metrics for the Validation System
Question and Answer Session