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.

Audience

  • Technicians in pharmaceutical manufacturing.
  • Quality control personnel.
  • Engineering/maintenance personnel.
  • Quality assurance and regulatory affairs.

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."
Fundamentals of Validation

Portability

This course must be taught at a BioNetwork location.

Level: Intermediate

Lecture HoursLab or Activity HoursTotal

Instructor Pool

Related Information
Bioprocessing: Join Us On The Edge
Video
This video is designed to educate beginning biotechnology students about specific career... more
Aseptic Gowning for the Cleanroom
Video
One of the primary safeguards that life science companies use to help prevent contamination in... more
Bioprocessing Part 3: Purification
Video
This video is the third in a series of three videos depicting the major stages of industrial-scale... more
Drug Development Overview
eLearning
This eLearning module will give you an understanding of the process used to develop drugs and why... more