Process Validation Principles and Protocols

Course Description
The FDA defines process validation as: “The collection and evaluation of data, from the process design stage through commercial production, which establishes scientific evidence that a process is capable of consistently delivering quality products.”

This course provides an interactive approach to processes validation. Class discussions focus on typical strategies for completing process validations, and through hands-on exercises, course participants gain practical experience with the planning, execution, and reporting of process validation.

Who Should Attend
This course is designed for individuals involved with process validation in the medical device industry, including R&D/Product Development Engineers, Quality Engineers, Process Engineers, Quality Assurance Managers, and Project/Program Managers.

Learning Objectives
Upon successful completion of this course, participants will develop the skills necessary to assure that their organizations’ quality management systems meets FDA and ISO requirements. These skills include:

  • Determining which processes do and do not require validation
  • Developing a Master Validation Plan
  • Evaluating process design to determine if the process is capable of reproducible commercial manufacturing
  • Using the validation for manufacturing/QC AQLs
  • Documenting the results of process validation
  • Planning for effective monitors and controls for the validated processes

Course Outline
Introduction and Overview of Terms and Topics

  • Qualifications
  • Validations
  • Process vs. Product Performance

Lot Quantities and Sampling Plans

Master Validation Plan

  • Review of possible templates and key issues
  • Determining Critical, Major, and Minor processes
  • Saving time by choosing what not to validate

Creating the Process Qualification Protocol

  • Using process capabilities
  • Reviewing tests and results

Testing and Report Writing
Equipment vs. manual processes (with examples)
Participants are encouraged to bring their own work and challenges to class.

Next Steps after Validation

  • Corrective actions
  • Revalidation plans
  • Updating risk analysis

Course Format
16 hours
Combination lecture and classroom exercises
Available at QSG’s training facilities and on-site at your organization


 

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