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​“Established since 1999”

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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:

  • How to communicate and document quality events.
  • How to communicate opportunities for improvement.
  • How to manage the uneasiness toward the ability to err.
  • How to react to GMP situational awareness.
  • How to develop rigorous error-prevention techniques during the execution of GMP activities.

Deliverables, Module II: 

  • Action Plan to correct and prevent validation and SOP GMP deficiencies.
  • Action Plan for the detection, correction and prevention of Human Error in manufacturing and laboratory operations.

MODULE I - Current Level: GMP Quality Culture:

  • Assessment of manufacturing quality events and laboratory failure investigations procedures.
  • Evaluation of selected manufacturing and laboratory investigation reports.
  • Evaluation of local and corporate quality policies.
  • Evaluation of employees’ cGMP training program.
  • Evaluation of employees’ task-specific training program.
  • Assessment of position descriptions for operators, analysts, supervisors and managers.
  • GMP Gap Assessment for Humans Errors, Human Factors and Human Error Precursors: Part I – Quality Culture.

Deliverables, Module I: 

  • Assessment report and action plan to correct and prevent cGMP deficiencies found.
  • Action plan to improve the GMP Compliance Culture.
  • Development of a company Policy in Human Error and Human Factors.
  • Embedding Human Factors Engineering techniques into GMP activities.

The program consists of three (3) modules for successful implementation.

MODULE II - Current Level: GMP Knowledge and Manufacturing Process Understanding 

  • Assessment of the current validated state condition - Manufacturing and Laboratory operations.
  • Assessment of Validation Protocols and Standard Operating Procedures (SOPs)  - Manufacturing and Laboratory operations.
  • Assessment of Training effectiveness - Manufacturing and Laboratory operations.
  • GMP Gap Assessment for Humans Errors, Human Factors and Human Error Precursors: Part II - GMP Knowledge and Manufacturing Process Understanding.

Training, Module I: 

  • Understanding Human Error, Human Factors and Human Error Precursors.
  • Applying Critical Thinking and Human Factors Engineering techniques during the execution of manufacturing and laboratory activities.

Eliminate Risks of Regulatory Fines or Enforcement Actions.


Maximize Competitive and Strategic Opportunities derived from Implementing GCGI’s Human Error Program (HEP) ™.

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.

Human Error

​Program

MODULE III - Application of Human Performance Technology (HEP) and Human Factors Engineering Techniques to GMPs 

  • Application of Human Performance Technology to GMP knowledge management.
  • Application of Human Factors Engineering to validation testing for compliant process development and continuous process understanding.
  • Human Factors validation protocols identifying, correcting and preventing problems during process development and analytical method testing activities.
  • Procedures preventing quality events during manufacturing and laboratory operations.
  • A Human Performance Technology approach to the detection, correction and prevention of systemic issues.
  • Performance Improvement as a tool for effective Corrective and Preventive Actions (CAPAs).
  • GMP application and practices geared toward work-group performance.
  • Quality-improvement initiatives focusing in operators, analysts, leaders and management.
  • Performance measurement and data assessment monitoring: Maintaining the validated state condition during commercial and product distribution activities.

GCGI's Human Error Program (HEP) ™

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 ®