Pharmaceutical Validation Processes Online Course & Certificate

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20 contact hours
Used For:
2 Continuing Education Units
Course and Certificate:

This course provides a basic understanding of the validation process as required by the Food and Drug Administration of the United States for drugs manufactured in the United States and all imported drugs. This course also reviews applicable definitions and descriptions of the process and documents required in the validation of a facility. The process of validation is explained along with the intent of the validation effort. Relationships between types of protocols and other documents which occur at the same time during the construction and startup of a pharmaceutical facility are explored. The final results of the validation process are described and how the effort is prepared for an FDA inspection is touched on.

Pharmaceutical Validation Process is ideal for the following professionals:

  • Facilities engineers and management within the pharmaceutical industry.
  • Engineers interested in the pharmaceutical field as employees.
  • Engineers in consulting companies interested in moving into the validation field.
  • Individuals who must prepare, read, approve and/or execute protocols.


After completing Pharmaceutical Validation Process, students will be equipped with a basic understanding of the following:

  • Overview and understanding of the validation process
  • How to organize it and carry out process validations
  • Key areas to look for during an audit
  • Various approaches to validation


No prior experience or coursework required. 

 Students will be assigned 5 homework assignments, and 1 final exam. 

  • Introduction to Pharmaceutical Validation

  • Process validation
    Prospective validation
    Retrospective validation
    Concurrent validation

  • Design qualification (DQ)

  • Installation qualification (IQ)

  • Operational qualification (OQ)

  • Process performance qualification (PQ)

  • Analytical validation
    General principles of analytical method validation
    Validation of following analytical instruments
    – HPLC
    – Dissolution test apparatus
    – U.V./Visible spectrophotometers

  • Equipment validation
    – Dry Powder Mixers
    – Fluid Bed and Tray dryers.
    – Tablet Compression M/c.
    – Dry Heat Sterilization/Tunnels
    – Autoclaves
    – Capsule filling machines.
    – Validation of Integrated lines by media fill test.
    – Validation of existing equipment.

  • Process validation of following formulations
    – Coated tablets
    – Capsules
    – Ampoules & Vials
    – Ointment/Creams
    – Liquid Orals

  • Computer System Validation


 This course is Instructor-led and delivered through our award-winning online Learning Management System. 

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