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REGULATORY COMPLIANCE SERVICES
FDA-Regulatory Laboratory Services
Analytical
Laboratory
Prevent impact on product quality due to data integrity issues at your site. Learn GCGI's Data Integrity Best Practices.
Please, feel free to browse or download our brochure which includes details about all aspects of the program.
Contact Johnny Guerra, former FDA Chemist & FDA Supervisory Chemist, to support your Laboratory Operations.
GCGI has a strong expertise in Laboratory Operations. By conducting laboratory assessments, GCGI has been able to detect emerging situations related to:
- Analytical method validation and analysis.
- Failure investigations.
- Qualification of equipment/instrumentation.
- Unidentified chemical compounds.
- Inadequate analytical techniques.
- Managerial controls.
- Deficient training programs.
- Data Integrity.
GCGI has provided the right guidance by implementing systems and processes to resolve above issues within a regulatory environment. Johnny Guerra, a former FDA Chemist and FDA Supervisory Chemist, ensures that GCGI’s Consulting, Auditing, Training and Laboratory Validation services are executed in compliance with all applicable statutory and FDA regulatory requirements.
The program is completely available via WEB!
Do you want to take your documenting skills to the next level? Become a Quality Event Solutions Expert (QESE) ™.
Johnny Guerra, former FDA Chemist and FDA Supervisory Chemist, conducts audits designed to uncover any potential weak areas in the Laboratory Control System. The comprehensive review, assessment and remediation activities support all laboratory operations.
Is your firm still struggling with repeated deficiencies when documenting laboratory failure investigations? GCGI’s THREE-TIER Program in Failure Investigations ™ provides the proper skill set required to prevent FDA-483 objectionable observations and FDA Warning Letters.
The program is completely available via WEB!