Go Back

COURSE ID 2686

Introduction to Validation Principles, Practices and Requirements

AVAILABLE On-demand
12 Hours

On-Demand

Offering Price
$ 2150
Register Now

You will be redirected to our secure system.

Team Training

When you need on-site attention, we’re not just here to help, we’re there to help—right by your side.

Individual courses are remarkably effective. But sometimes when you have a specific need, it helps to have expert guidance right in the room with you and your team.

In that case, we’re happy to design a custom training for your entire team, whether online—or on-site.

Learn more

Remember – at checkout you can choose to take this course On-demand. We offer a 10% group discount when you register 2 of more attendees (up to 10). Contact us for larger groups.

ACCREDITATION CEU's - 1.2 IACET RAPS
View Course Outline

FDA regulated industries utilize several types of validation to help ensure the quality of their products and to comply with FDA and international regulations and requirements.

This 12-hour, accredited ON DEMAND course provides an overview and introduction to Validation principles and requirements. Discussed in this program are:
-Process validation
-Computer System Validation
-Cleaning validation
-Methods validation
-Qualifications
-Validation Project Management

The course is designed to provide a basic understanding of 4 classifications of validation that are generally recognized throughout the industry and by regulators. The program provides an effective and efficient transition to more advanced and specialized validation programs and responsibilities. To further enhance the lecture material, case studies, discussions, protocol reviews, and interactive exercises will be employed.

who should
attend?

LEVEL
Introductory
INTERESTS
Biotechnology / Biopharmaceutical Medical Devices / Diagnostics Pharmaceutical Science & Technology

This course is designed for professionals in the Pharmaceutical and Medical Device industries who have validation responsibilities, who have a need to understand validation requirements, who desire to conduct and manage validation functions and who have a desire to understand validation types and requirements.

The course will be especially beneficial to professionals in the Quality, Regulatory, Engineering and Auditing areas.

course instructor

Philip E. Sax
Consultant to the Life Science Industry

Philip E. Sax’s Courses
Phil Sax is an early thought leader for CSV. A Founder and President of Weinberg Spelton and Sax, a Computer System Validation Consultancy, he has been involved in hundreds of successful validation projects. He has trained more than 1000 professionals, including FDA staff, and has served as Vice President and Chief Regulatory and Quality Officer for 3 international companies. Phil has consulted and worked in 19 countries throughout North America, Europe, Asia, and the Middle East. Phil testified to the US House of Representatives about Computer System Validation issues. Since 2014 Phil as served as an Adjunct Assistant professor in the Masters of Regulatory Affairs and Quality Assurance Program of the Pharmacy School at Temple University. He has developed and directed courses in Validation, Good Clinical Practices, and Drug Development, He maintains an active compliance and regulatory affairs consultancy.

related courses

90 Minutes

Handling OOS Test Results and Completing Robust Investigations

2 Hours

Basics of Vaporized Hydrogen Peroxide (VHP) Sterilization and Decontamination Practices

12 Hours

Successful FDA Inspections: Essential Preparation and Management Tools

90 Minutes

Understanding the Process Validation Life Cycle