Learn How To Think Like The FDA ®
FDA-oRIENTED
“Established since 1999”
GUERRA
consultinggroup,inc.™
REGULATORY COMPLIANCE SERVICES
FDA-Oriented Regulatory Compliance Services are provided to QA, Manufacturing and Laboratory Operations in the following areas:
- Response to FDA-483s.
- Response to FDA Warning Letters.
- Failure Investigations, Root-Cause-Analysis (RCA) & Problem-Solving Techniques (PST).
- Implementation of Corrective and Preventive Action Plans (CAPA).
- Human Error Detection, Correction and Prevention’s Program.
- Organizational Compliance Program (OCP).
- Organizational Change Management (OCM).
- Human Performance Technology.
- Laboratory cGXP and Manufacturing cGMP Controls.
- Development of a QA Compliance Investigation Unit (CIU).
- Data Integrity in Laboratory and Manufacturing Operations.
- Line Clearance, Mix-Ups, Mix Labels, Short Fill & Complaint Events.
- Master Certification Plan for Laboratory Analysts (MCPLA).
- Master Certification Plan for Manufacturing Personnel (MCPMP).
- Master Computer System Validation (CSV) Certification Program.
- Master Validation Plans and Change Control Program.
- Process Analytical Technology (PAT).
- Worldwide Vendor Audits: QA, Data Integrity and Instrument/ Equipment Manufacturers.
- Electronic Records; Electronic Signatures (21 CFR Part 11).
- Cleaning Validation Program.
- Drug Master Files (DMF) & NDAs.
- Mock Pre-Approval Inspections (PAI) and Facilities Planning and Design.
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If you have any questions, requests or comments, you can always contact us:
Guerra Consulting Group, Inc. (GCGI)
About Us
Established in 1999, GCGI™ provides consulting, auditing, training and validation services to the Pharmaceutical, Active Pharmaceutical Ingredient (API), Biotechnology, Medical Device, Discovery Work and R&D industries in Puerto Rico, USA, Canada, Europe, China, Japan and other countries.
All services are conducted by Johnny Guerra, drawing from “20 Years of FDA Experience and Knowledge at Your Service" ™, and additional 22 Years of International Consultancy offering excellency on client needs, task execution, problem solving and timely completion of studies, analysis, projects and presentations.
Whenever additional manpower is required, GCGI brings qualified resources to fulfill such needs. With its extensive Quality Assurance (QA) knowledge, Guerra understands the real word needs and the impact that procedures and processes can have on a given operation. Concise information delivery is the guiding principle in our business.
Before accepting a project, we will confer with the client in sufficient detail to understand its scope. The recommendations are performed on an individual basis and developed specifically for the practical solution of each client’s problem.