Course Dates Upcoming Dates and Locations Virtual seminars run as 1/2-day sessions. In-person classes run as full-day sessions. See the virtual session daily class times. There are no public training classes scheduled right now but this class can be delivered privately to 6 or more people at any time. Ask us for details!
Course Details Objectives Understand the purpose, benefits and objectives of process validation Discuss ISO and FDA requirements for process validation as an integrated model Recognize planning and resource requirements Understand integration of computer systems controls into operations and facilities validations Describe the concepts of prospective, retrospective validation, and revalidation Understand performance qualification and equipment qualification, installation qualification, and operational qualification Differentiate between equipment, process, and product Understand validation techniques: organizing teams, process characterization, and process flowcharts Explain validation parameters: operating and process conditions, test methods, results analysis, acceptance criteria, limits testing, and computer control Follow validation protocols: guidelines, format, and presentation Establish records documentation requirements Topics Introduction to process validation Key definitions and terms Principles and protocols Process validation Special process recognition Facilities validation Utilities and equipment Process capability design and qualification Validation program Who Should Attend Recommended for mid-level technical management, manufacturing engineering, facilities, production management, and quality assurance professionals involved in planning, executing, reporting, and maintaining manufacturing process validation. Virtual Half-Days In-Person Full-Days CEUs 0.8