Course offering number:0912-701
Course ID:
2327
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Pharmaceutical Process Validation Basics
In Conjunction with Wiley-Blackwell
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, 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
• Quality Assurance and Control
• Manufacturing/Operations
• Facilities
• Finance
• IT
This training will also benefit suppliers of equipment and services to the industry.
Description
In recent years, the FDA has placed intense focus on Process Validation. This 90-minute accredited online 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:
• 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?
• Which processes are considered highest risk and will get
the most scrutiny?
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