Fundamentals of Validation

Fundamentals of Validation

This course is designed to introduce technicians and professionals to the principles and regulatory requirements of current drug, biologic and medical product validation. A brief historical overview of regulatory requirements is followed by current requirements, user needs, process design and control, qualification, process validation, and cleaning validation activities. Hands-on activities are utlized to enhance understanding.

Topics Include

  • Factors precipitating FDA’s validation concept and approach.
  • Design, installation, operational, and performance qualification.
  • Foundational concepts and approaches established by FDA’s 1987 “Guideline on General Principles of Process Validation.”
  • The “Design Control” approach to medical device validation.
  • The influence and impact of CGMPs on validation
  • Validation principles updated by the 2011 FDA Guidance to Industry “Process Validation: General Principles and Practices.”
  • The regulatory basis for drug and medical device validation requirements.

Learning Objectives

  • Gain an understanding of the motivation and purpose of medical product validation.
  • Differentiate between the qualification and validation practices.
  • Be orientated to requirements of the 2011 FDA Guidance to Industry "Process Validation: General Principles and Practices" and EudraLex Vol. 4 Annex 15 "Qualification and Validation."

Audience

  • Technicians in pharmaceutical manufacturing.
  • Quality control personnel.
  • Engineering/maintenance personnel.
  • Quality assurance and regulatory affairs.
850 Oval Drive
Raleigh, NC 27695
Instructor
Rosa Fernandez
Class Dates
  • November 9, 2018
Class Days & Times
  • Fri - 8:00 AM to 5:00 PM
Class Level
Intermediate
Lecture Hours
8.00
Lab Hours
0.00
Total Contact Hours
8.00
Building
BTEC
Room
120
Format
Face-to-Face
Course ID
199265