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​“Established since 1999”

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REGULATORY COMPLIANCE SERVICES

Ready to achieve optimal control strategies by knowing how to document Quality Events?

GCGI’s Failure Investigations & Quality Events Program ™

• GCGI’s THREE-TIER PROGRAM in FAILURE INVESTIGATIONS ™
  
• GCGI’s Quality Events Certification Program ™
  
• GCGI’s QA Compliance Investigation Unit (CIU) ™
  
• GCGI's Human Error Program (HEP) ™​
  

Quality Events

See Our Training Courses in Human Error and

Quality Events.

Achieving optimal control strategies supported by in-depth understanding of the causes of variability for both products and processes is the main goal of each program module. Participants completing program modules will be able to identify, document, correct and prevent errors and product failures before a lot or batch can be released.

Past experience with companies that have completed the program reveal consistent operations on “batches-right-the-first-time”, indicative of robust processes and quality products. 

Inadequate documentation of Manufacturing Quality Events and Laboratory Failure Investigations often leads to product recalls and poor FDA inspection outcomes indicative of broader deficiencies in manufacturing and laboratory operations.  

GCGI’s Quality Events Program™ involves consulting, auditing and training activities allowing participants to properly identify and resolve non-conformances, discrepancies, deviations and poor process controls. FDA-regulatory techniques addressing laboratory analysts, operators and supervisory performance as well as equipment, facilities and product/process characterization and validation controls are included as well.

GCGI’s Quality Events Program Modules:

"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.

The quality of your work has been recognized and appreciated locally and by other functional team members worldwide. With your assistance, we extended the 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."

Consulting, Auditing and Training Activities:

• Evaluation of Manufacturing Quality Events & Non-Conformances.
• Development of Quality Event/Failure Investigation Programs.
  
• Development of Quality Policies in the Detection, Correction and Prevention of Human Errors.
  
• Development of a Compliance Investigation Unit (CIU) for Manufacturing and Laboratory Quality Events.
  
• Development of a Corrective and Preventive Action Plan (CAPA) Monitoring Program.
  
• Implementation of a Root-Cause-Analysis (RCA) System.
  
• Implementation of Problem-Solving Tools (PST).

Learn How To Think Like The FDA ®