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.”
Who Should Attend
This process validation training 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.
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
Introduction and Overview of Terms and Topics
- 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
Combination lecture and classroom exercises
Available at QSG’s training facilities, on-site at your organization, and virtually
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