Event Details
8 hours
Combination lecture and classroom exercises
Available at QSG’s training facilities and on-site at your organization
Participants will learn about principles of cGMP applied to product analysis and discovery, development, manufacturing, verification and validation.
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Please contact us if you are interested in private training for this workshop.
8 hours
Combination lecture and classroom exercises
Available at QSG’s training facilities and on-site at your organization
In the United States, a government agency, the Food and Drug Administration (FDA), establishes regulations that govern the sale of food, drugs, biologics and medical devices. FDA requires that manufacturers in these industries establish and maintain quality systems to ensure that their products meet the usability and safety needs of their customers. Quality systems for products that are governed by the FDA are based on Good Manufacturing Practices or GMPs.
The GMP compliance requirements for medical devices are outlined in the Code of Federal Regulations (CFR), most prominently in the FDA Quality System Regulations of 21 CFR Part 820. This part establishes the requirement for quality systems in medical device companies, mandating quality procedures such as design controls, CAPA process, quality assurance and quality control activities, document controls and more.
GMP Training requirements also include other portions of the CFR. 21 CFR Part 812 deals with investigational device exemptions, allowing devices to be shipped lawfully for the purpose of clinical investigations when they would otherwise be required to comply with a performance standard or to have premarket approval. 21 CFR Part 808 addresses exemptions from Federal regulation of state and local medical device requirements.
Engineers, PMs, quality assurance professional, quality control managers, regulatory affairs, auditors, production engineers and managers, and management would like to apply current GMP compliance tools and techniques to their environment.
This cGMP training course is designed for anyone who needs a good understanding of current Good Manufacturing Practices. Learn about cGMP environment, procedures and processes, roles and responsibilities applied to cGMP quality. Participants will learn about principles of cGMP applied to product analysis and discovery, development, manufacturing, verification and validation.
Please visit our Training Page for all Training Events.
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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