Learn How To Think Like The FDA ®

FDA-oRIENTED​

​“Established since 1999”

​​​​​GUERRA

consultinggroup,inc.™

REGULATORY COMPLIANCE SERVICES

MODULE I: GCGI’s Organizational Compliance Program (OCP)™

Organizational Change

​Management

Business leaders, first line managers (supervisors) and directors must be equipped with the right skills and knowledge to effectively lead transformational regulatory compliance change. The people and cultural side of change often tends to be ignored resulting in more than 75% of failing change initiatives. Even though several factors could contribute to this failure, two factors create mayor impact:

  • The compliance change process is not being managed effectively.
  • People impacted by the compliance-related change are not guided effectively.


GCGI’s Organizational Compliance Program (OCP)™ provides individuals with knowledge and tools to understand and apply transformational leadership leading towards regulatory compliance change. 

Eliminate Risks of Regulatory Fines or Enforcement Actions.


Prevent losing Major Clients!


GCGI’s OCP ™ will get your Organization and Quality/Compliance System to the next level increasing efficiencies and product value.

  • Identifying regulatory compliance constraints.
  • Identifying the types of compliance-related changes to be tracked.
  • Measuring probability and volume of change.
  • Personnel requirements to manage and evaluate compliance-related change requests.
  • Defining compliance management roles, responsibilities and competencies.
  • Managing logging, monitoring and reporting requirements.
  • Defining evaluation process and principles.
  • Establishing guidelines for communicating regulatory compliance changes to the organization.​