Medical Device

Training
This online course, the first in a four-part series, describes regulatory requirements and expectations regarding the validation and compliance of computerized systems used in the manufacture of pharmaceuticals,...
Training
This online course has been designed to assist FDA inspectors in recognizing the critical aspects of computerized systems in the medical device industry. This course explains how computerized systems are used in the...
Training
This online course provides you with the basic competencies required to effectively perform the auditor’s assigned responsibilities by defining audits, explaining why audits are carried out, discussing the types and...
GMP Regulation Handbooks
Regulation Handbook: 21 CFR Part 820: Medical Devices Quality Systems Regulation (formerly known as Current Good Manufacturing Practice for Medical...