​​Organizational Change Management (OCM)

Human Performance Technology (HPT)

GCGI’s Human Error Program (HEP) ™

GCGI’s Data Integrity Program (DIP) ™

         Quality Assurance & Manufacturing

         Laboratory Operations

Computer System Validation (CSV)

GCGI’s Compliance Investigation Unit (CIU) ™

GCGI’s Failure Investigations & Quality Events Program ™


 

​“Established since 1999”

consultinggroup,inc.™

GCGI’s Organizational Compliance Program (OCP)™

Learn How To Think Like The FDA ®

​​​​​GUERRA

  • Evaluation of the quality program supporting process validation activities.

               Enable the detection and degree of variation.

               Understanding the impact of variation on the process                               and product attributes.

               Controlling process variations.

               Maintaining the process in a state of control over the life                         of the process.

  • ​Establishment of Process Performance and Product Quality Monitoring System.
  • Proper identification and control of areas of potential process weakness.
  • Proactive deviation and investigation systems leading to timely remediation.
  • Prompt identification of processes, product quality performance gaps, and promptly correction of root causes.
  • Facilitate effective knowledge transfer and management.
  • Implement Corrective Action / Preventive Action (CAPA) and a System Change Management System.
  • Facilitate continual improvement through active Management Review.

Organizational Compliance Program (OCP)™

FDA-oRIENTED​

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.

How does the organization ensure that people will live up to company’s expectations?

How will the organization know if those expectations are reasonable?

How does the organization ensure compliance to FDA regulatory requirements?

The quality of your work has been recognized and appreciated locally and by other functional team members worldwide. With your assistance, we extended the Compliance Investigation Unit​ (CIU) concept to include sister companies dealing with product suppliers and equipment vendors. A complete success too!

 Again, I would like to express my sincere thanks for your contributions to the successful implementation of a Quality Event and Failure Investigations Program at our site. I look forward to the opportunity to work together again."

"Dear Johnny:"

"I am writing this letter to thank you for your outstanding work in helping us succeed after receiving the FDA Warning Letter. You helped us at a very busy and critical time. Your regulatory and technical expertise and attention to detail were tremendously valuable resulting in zero (0) FDA-483 objectionable observations during the FDA follow-up inspection.

The implementation of GCGI’s THREE-TIER PROGRAM in FAILURE INVESTIGATIONS, GCGI’s Human Error Program and the development and implementation of a QA Compliance Investigation Unit (CIU) at our site really made a difference by changing our previous mindset into quality-oriented generating value and increased product revenues.

REGULATORY COMPLIANCE SERVICES

GCGI’s Organizational Compliance Program (OCP)™ helps GxP life sciences organizations comply with FDA requirements through organization-specific mandates and policies.


There are many factors that go into the determination of an organization’s policies, including statutory and regulatory requirements, company best practices, and market demands. GCGI’s OCP™ aims towards the intersection of policy and practice through knowledge transfer, enforcement of policies and measure of their effectiveness.

Experience has shown that creating a policy without any mechanism to measure and monitor compliance – in a “real life” scenario, is not effective. GCGI’s OCP™ organizational policies map out the expected FDA regulatory compliance actions that the organization should follow, enhancing business goals and product predictability.

  • Help understand the legal and statutory requirements that will shape the policy within the organization.
  • Development of effective models integrating policy and regulatory requirements with people, processes and technology. This includes training, mentoring, coaching and monitoring.
  • Knowledge transfer of FDA regulatory compliance requirements, follow-up and documenting results.
  • Methodology that allows the organization to actively review, monitor, enforce, and/or adapt the policies as necessary to ensure that they effectively and accurately measure and report on conformance.
  • Methodology that provides mechanisms necessary for the organization to react quickly should policy or processes require adaptation in the rapidly evolving business environment.
  • Development of worldwide organizational compliance establishing well-defined and designed processes and products, from development through the entire product life cycle.​
  • ​Establishment of business goals of process and product predictability, i.e., Right First Time.