If you need a road map or help along the way, we can help.

QualityHub, Inc. can provide training programs to meet the needs of both the device and drug industries. We provide both "off the shelf" and custom training programs in FDA Inspection Readiness, QSIT, Quality Systems, CAPA, Investigations, and Quality Systems for Devices and Pharmaceuticals. Our trainers are recognized experts who have performed international training for FDA and industry on a wide variety of subjects.

Our trainers have experience on numerous international committees such as the Global Harmonization Task Force (GHTF) for auditing, the Association for the Advancement of Medical Instrumentation (AAMI) for CAPA, Quality Systems, Sterilization and Design Controls, the ISO technical committees on Sterilization, Clean Rooms, Quality Management, Clinical Laboratory Testing and IVD test systems.

We have former FDA Investigators, compliance officers, a former FDA National Expert Investigator and former District Device Specialist. Our industry associates are each recognized nationally and internationally for their knowledge and training. Our founder was the former leader of the FDA team who wrote and developed the FDA's Medical Device QSIT Program including the CD-Rom training program for FDA investigators.

To discuss possible training initiatives please contact us today! Please visit our Connect page to contact us.