“Established since 1999”
REGULATORY COMPLIANCE SERVICES
GCGI’s program adapts principles from Human Performance Technology (HPT), Human Factors Engineering (HFE) and Regulatory Critical Thinking (RCT) to accomplish specific task objectives during the execution of cGMP activities.
The program concentrates in both the individual and management behaviors needed to reduce error, as well as improvements required at the local and corporate level to better support employees’ performance.
GMP knowledge and FDA regulatory expectations are emphasized during the program so that managers, supervisors, operators, analysts and support personnel can better identify and eliminate error-provoking conditions that could trigger human errors in manufacturing and laboratory operations.
The program addresses procedures to control error-provoking conditions, in particular:
Deliverables, Module II:
MODULE I - Current Level: GMP Quality Culture:
Deliverables, Module I:
The program consists of three (3) modules for successful implementation.
MODULE II - Current Level: GMP Knowledge and Manufacturing Process Understanding
Training, Module I:
GCGI's Human Error Program(HEP)™ was developed in 2007 as an extension of cGMP manufacturing and laboratory Failure Investigations and Quality Event activities. Since more than 80% of quality events are often associated to human factors, the program provides effective solutions during the detection, correction and prevention of human errors in FDA-regulated industries.
MODULE III - Application of Human Performance Technology (HEP) and Human Factors Engineering Techniques to GMPs
Learn Human Performance Technology (HPT), Human Factors Engineering (HFE) and Regulatory Critical Thinking (RCT). E-learning training activities are presented live including individual and group discussions, workshop exercises and Q&A sessions.
Learn How To Think Like The FDA ®