At Confirm we have the philosophy that we are the best at what we do, but it does not mean that we will keep the knowledge to ourselves.
We focus on Distributed Control Systems from ABB, Emerson and Siemens. Our training materials are organized so that they function as a supplement to the manufacturer’s existing courses.
Our GMP / GAMP courses are aimed at the practical application of norms, standards and guidelines within Pharmaceutical automation projects. The curriculum reviews the content of the GAMP 5 document and then applies it to the real world. We illustrate with an example studies and examples from the manufacturer’s system.
We push ourselves for continuous improvement by asking our students to evaluate the course the last day, both for the trainer and the material provided.
Qualification and Validation
We teach current standards and trends in GxP qualification and validation. During the course, you will be encourage to strengthen your skills through the operation of the manufacturing equipment.
Data integrity is one of the most important GxP topic, with great focus on inspections of GxP systems.
ISPE has released a guide, ISPE GAMP® Guide: Records and Data Integrity. This helps to interpret the governing agencies’ expectations and the industry’s ability to keep GxP data in compliance.
The ISPE guide is distinguished from GAMP 5 guide because it takes all other important guidelines for data integrity and places them into one all-encompassing guide.
We can customize teaching for every need, and have arranged specially adapted courses on many different topics. Course duration ranges from 1-hour ‘turbo-intro’ to 1/2 days of brush-up seminars to a full-week programs of project-focused teaching.
If you want to hear more about our courses or discuss the possibility of a personalized course, please send us an email firstname.lastname@example.org or call (919) 676-5351.