Guerra Consulting Group, Inc. (GCGI)™, established in 1999, provides FDA-related consulting, auditing, training and validation regulatory compliance services to the Pharmaceutical, Active Pharmaceutical Ingredient (API), Biotechnology, Medical Device, Cosmetic, Discovery Work and R&D industries in USA, Europe, China, Korea, Japan India, Puerto Rico, Mexico, Brazil, Argentina and other countries. GCGI assist clients by identifying constraints and potential limitations at the system and unit level through in-depth investigations of system operations, failures, non-conformances and deviations followed by adequate corrective and preventive action plans. GCGI has identified business and regulatory risks by conducting Pre/Post FDA Approval Inspections. Corrective and Preventive Action Plans (CAPAs) have been adequately implemented to meet both regulatory and firm’s requirements. GCGI's "THREE-TIER PROGRAM IN FAILURE INVESTIGATIONS – MANUFACTURING AND LABORATORY OPERATIONS" ™ provide firm's employees with a set of knowledge and skills to adequately implement a Quality Event and Failure Investigation System from an FDA Regulatory and Technical perspective geared toward the prevention of FDA-483 objectionable observations, Untitled Letters, Warning Letters and other enforcement actions. Afterwards, the program becomes a Process Excellence quality management tool. Please visit us at www.guerraconsultinggroup.com and join the hundreds of satisfied customers who have experienced the difference at GCGI and come to know why we are a leader in the FDA-regulated industry.