Event Details
24 hours
Combination lecture and classroom exercises
Available at QSG’s training facilities, on-site at your organization, and virtually
This process validation training course is designed for individuals involved with process validation in the medical device industry.
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24 hours
Combination lecture and classroom exercises
Available at QSG’s training facilities, on-site at your organization, and virtually
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 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:
Introduction and Overview of Terms and Topics
Lot Quantities and Sampling Plans
Master Validation Plan
Creating the Process Qualification Protocol
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
Chris, Angelo and Barbara,
The recent meeting “What we can learn from FDA Warning Letter” was an excellent and exactly what I was looking for. Please keep me on the list for future meetings. Real professional of you folks. I have given your companies information out to an acquaintance from ASQ as a source for training for internal auditing. Looking forward to a long relationship with your team.
Hi Angelo,
Great ISO 13485:2016 Internal Auditing class, honestly the most well run and informative class I’ve taken.
Hi Angelo,
We are satisfied with the process and the report. Gordon does a good job! He is up on the regulations and what we need to focus on. I have found in past years what he points out is what comes up on the radar with the Notified Body. It helps us to be ready for the process.
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