Medical Device GMP (Good Manufacturing Practice) Training - 1 DAY
This introductory medical device FDA GMP training class is conducted on-site by a senior Emergo Group consultant. Our consultants are have real world manufacturing experience and are not professional “canned” presenters that travel from city to city. This ensures that your team will get a high quality FDA GMP training session tailored to the needs of your organization. Best of all, this GMP training class will be conducted at YOUR facility, saving you the time and cost of sending employees off-site for training. Please note that this FDA GMP training class is tailored to medical device and IVD companies and is not applicable to pharmaceutical, food and cosmetic manufacturers.
Professional, on-site training at your facility for one fixed fee, regardless of how many employees attend!
Our fee for training is based on a set daily fee plus basic travel expenses. This makes it a great value for companies that need to train more than two employees at one time. On-site training gives your employees the opportunity to ask questions (something they can’t do easily with online classes) and ensures that every employee is hearing consistent information at the same time.
What your team will learn in this intensive FDA GMP training class:
- History of the US Food and Drug Administration (FDA) and GMP (QSR).
- Discussion of the Quality System Regulations (QSR).
- General provisions of GMP (also known as cGMP).
- Responsibility of management and need for adequate staffing.
- Conducting audits, taking corrective action and documenting results.
- Creating design controls: input, output, validation, transfer, changes and documentation.
- Purchasing and the evaluation of suppliers.
- Identification and traceability of products.
- Dealing with production and process changes, plus process validation.
- Inspection, measuring and testing equipment.
- Acceptance activities.
- What to do with non-conforming products.
- Corrective and preventive actions (CAPA).
- Labeling, storage, distribution and installation.
- Records and servicing of products.
- Plus much more.
