Course offering number:0904-709
Course ID:
2303
An Overview of Process Validation for the Pharmaceutical, Medical Device and Related Industries
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 Pharmaceutical, Medical Device and related industries. 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
• Manufacturing/Operations
• Finance
• QA/QC
• Quality Assurance and Control
• Facilities
• IT
This training will also benefit suppliers of equipment and services to these industries
Description
In recent years, the FDA has placed intense focus on Process Validation. This 90-minute accredited training course will examine 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:
• 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:
• The Validation Master Plan
• Basics of validation
• URS, DQ, FAT, IQ, OQ, PQ: What are all these letters in
the alphabet soup?
• Protocol basics and content
Module 3:
• Handling deviations
• Validation reports
• Proper validation timing
• Maintaining the validated state
• Auditing metrics for the validation system
Question and Answer Session