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Course
Fundamentals of Validation
Name
SEF-165CL
Available Classes
    Section Location Begin Date End Date Instructor Price Seats Available/Total Seats
214180 BTEC BioNetwork Capstone Learning Center 11/07/2019 11/07/2019 R. Fernandez $150.00 20/20
Description Course Outline Requirements Intended Audience More Details
Description
This course is designed to introduce technicians and professionals to the principles and regulatory requirements of current drug, biologic and medical product validation.
Course Objectives
  1. Understand the motivation and purpose of medical product validation.
  2. Understand the difference between "qualification" and "validation" practices.
  3. Be orientated and become familiar with requirements of the 2011 FDA Guidance to Industry "Process Validation: General Principles and Practices" and EudraLex Vol. 4 Annex 15 "Qualification and Validation".
Outline of Instruction
  1. Introduction: factors precipitating FDA’s validation concept and approach
  2. Foundational concepts and approaches established by FDA’s 1987 “Guideline on General Principles of Process Validation”
  3. Medial device validation - the “Design Control” approach
  4. The influence and impact of modern cGMPs on validation
  5. Validation principles updated by the 2011 FDA Guidance to Industry “Process Validation: General Principles and Practices”
  6. Compare and contrast the 011 FDA Guidance to Industry “Process Validation: General Principles and Practices” with the 2015 EudraLex Vol. 4 Annex 15 “Qualification and Validation” Guideline
  7. The regulatory basis for drug and medical device validation requirements
Contact Hours
8
CEU's
0.8
Industry Standard, State, or National Certification
No
CE to CU Articulation
No
Prerequisites
Text and Supplies Needed
Clinical Site/Special Facilities
Requirements for Successful Completion of this Course
  1. Attendance 80% or above
  2. Participation
Accreditation/Special Approval Requirements
Intended Audience
Specific Industry or Business Support Needs
Industry or Job Titles Related to training Outcomes for Employment
Related Courses
Course Contact Information
Bionetwork Manager