Organizational Change Management (OCM)
Human Performance Technology (HPT)
GCGI’s Human Error Program (HEP) ™
GCGI’s Data Integrity Program (DIP) ™
Quality Assurance & Manufacturing
Computer System Validation (CSV)
GCGI’s Compliance Investigation Unit (CIU) ™
GCGI’s Failure Investigations & Quality Events Program ™
GCGI’s OCP™ responds to the following questions:
“Established since 1999”
Learn How To Think Like The FDA ®
GCGI’s Key points FoR the Organizational Compliance Program (OCP)™
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.
Organizational Compliance Program (OCP)™
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."
"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)™ encompasses the following modules:
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.
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guerra consulting group, inc. (GCGI)™
P.O. Box 193271
san juan, P.r. 00919-3271
PHONE: (787) 283-1518
MOBILE: (787) 399-1211