This course is designed for individuals responsible for planning and operating a compliant validation program.
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Please contact us if you are interested in private training for this workshop.
24 hours
Combination lecture and classroom exercises
Available at QSG’s training facilities, on-site at your organization, and virtually
The Medical Device and Pharmaceutical industries share the common goal of bringing safe and effective products to market as quickly and efficiently as possible. Process Validation is a formal methodology that allows companies to manufacture products on approved and qualified equipment, with a defined process leading to products that consistently meet predetermined specifications and quality requirements. This course provides an understanding of the regulatory requirements for process validation and their relationship to the Medical Device QSR and the Pharmaceutical cGMPs, and prepares participants to plan and operate a compliant validation program.
This course is designed for individuals responsible for planning and operating a compliant validation program, including:
Through training, participants will:
Day One
Day Two
Day Three
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.
Thanks for letting us know!
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