Introduction to Validation Principles, Practices and Requirements

Duration: 12 Hours
Course Instructor

Philip E. Sax

$ 2330
Discounts: We offer a 10% group discount when you register 2 or more attendees (up to 10). Contact us for groups over 10.

Course description

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 training course provides an overview and introduction to Validation principles and requirements. Process validation, Computer System Validation, Cleaning Validation, Methods Validation, Qualifications, and Validations Project Management are all topics discussed in detail during this program.

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.

Upon completion of this course, you will be able to:

  • Explain and understand basic validation concepts
  • Implement FDA validation guidance and regulations
  • Define the meaning of words within the validation vocabulary
  • Describe the basic concepts of:
    – Process Validation
    – Computer System Validation
    – Cleaning Validation
    – Methods Validation
    – Qualifications
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This course is designed for professionals in the Pharmaceutical, Food, Cosmetics Quality, Regulatory, 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


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