Learn How To Think Like The FDA ®
“Established since 1999”
REGULATORY COMPLIANCE SERVICES
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Manufacturing and Laboratory data integrity issues have been repeatedly found during FDA audits. The uncertainty of the origin and creation of data is often the result of inadequate controlled processes, lack of a continuous validated state condition and management oversight. GCGI provides complete data integrity services emphasizing in manufacturing and laboratory data integrity gap analysis, evaluation of the validated state condition, evaluation of SOPs as an outcome of validation activities, evaluation of computer, instruments and equipment, evaluation of software application program error logs, and how to document vendor’s software design limitations and anomalies that could impact cGMP activities. GCGI’s systemic approach to data integrity includes the detection, correction and prevention of data manipulation, fabrication and deletion of records that undermine the truthfulness of data. GCGI’s unique approach incorporates Human Performance Technology (HPT), human error reduction and the resolution of human error precursors that often trigger data integrity issues impacting the quality of cGMP operations. The implementation of GCGI’s systemic approach avoids the possibility of the FDA calling into question the integrity of cGMP data associated with commercial distributed products.
Numerous FDA-483 objectionable observations recall failures from the quality unit to investigate cGMP deviations during manufacturing and laboratory operations. Lack of an in-depth evaluation of the event have a direct quality impact to the implemented corrective and preventive action plan (CAPA). GCGI’s approach to failure investigations and quality events encompasses all aspects of manufacturing and laboratory operations. GCGI’s “learn-by-doing” approach provides powerful tools and methods that the firm can use regularly and systematically to define and resolve root causes, not just symptoms. From the evaluation of quality events, training in failure investigations, human error detection, correction and prevention up to the development of a Compliance Investigation Unit (CIU), GCGI’s Quality Events Certification Program™ allow your personnel to effectively obtain the knowledge and develop skills and abilities to document thorough investigations and meaningful CAPAs as well. The certification program allow individuals to become a Quality Event Solutions Expert™ enabling a quality-driven sustainable operation during the execution of manufacturing and laboratory activities.
There are many roadblocks when responding to FDA Warning Letters. Many times the response is not complete, thorough and unrelated to objective evidence demonstrating firm’soperations within a validated state of control. GCGI provides full support addressing the nature and seriousness of FDA objectionable observations underlining a plan with schedules for completion and the inclusion of broader issues implicated by the observations. GCGI assist companies developing a solid remediation plan emphasizing what is needed to correct at the local and company-wide level. GCGI has implemented comprehensive, thoughtful, and detailed plans addressing firm’s deficiencies ensuring full sustainability, management involvement and monitoring support for continuous regulatory level of compliance.
GCGI’s past experience shows no FDA-483 objectionable observations as a follow-up to the FDA Warning Letter.
FDA WARNING LETTER
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