Learn How To Think Like The FDA ®
“Established since 1999”
REGULATORY COMPLIANCE SERVICES
In addition, Mr. Guerra has published several articles in Pharmaceutical Technology on Method Validation, Quality Assurance, GMPs in the Chemistry Laboratory, Laboratory Computer Validation, Instrument Design, Power Failure Detector and others, has authored many technical papers, reports and course manuals including a chapter titled “FDA Approach to Laboratory Inspections” ; A Laboratory Quality Handbook of Best Practices, ASQ Quality Press, and others published in FDA’s internal scientific journal “Laboratory Information Bulletin” (LIB).
Throughout his 20 years of FDA career, Mr. Guerra has earned hundreds of awards including Cash Awards for instrument design, Cash Awards for computer audit and development, Commendation Letters for speeches and training, seminar development, publications, project management, managerial abilities and the "FDA Commendable Service Award" for outstanding performance in the development of the automation process for FDA’s nationwide field offices and San Juan District laboratory automation.
As an International Consultant, Mr. Guerra has also excelled in World-Wide Consulting, Auditing and Training activities by providing the Pharmaceutical, Biotechnology, R&D and Medical Device industry with FDA-Related Regulatory Expertise in the design and implementation of Laboratory/ Manufacturing Failure Investigations, Quality Events,Human Factor/Human Error Precursors , Organizational Compliance Program and Data Integrity (QA/Manufacturing, Laboratory) Programs. Such programs place emphasis on deviations related to Human Errors, Data Integrity, Consumer Complaints, Line Clearance, Mix-Ups, Mix-Labels and Short-Fill situations. He has also assisted management in responding to FDA-483s, Untitled/ Warning Letters and executed Part 11 (Electronic Records; Electronic Signatures) & Data Integrity Risk Assessment/GAP Analysis, Computer System Validation (CSV), Software Vendor Audits and Laboratory/CSV Certification Programs.
In the Validation area, Mr. Guerra has conducted Computer and Software Validation (including Data Integrity and Part 11) studies of Chromatography Data Acquisition Systems to Waters® Millennium32 and Waters® Empower in several Pharmaceutical Companies.
Mr. Guerra is very active as an educator and has provided courses for the last 42 years to FDA Investigators and Chemists, Service & Scientific Instrument and Calibration Companies and the Pharmaceutical, Biotechnology, R&D and Medical Device industry through the American Chemical Society (ACS), Pharmaceutical Manufacturing Association (PMA), Parenteral Drug Association (PDA), Institute for International Research (IIR), Pharmaceutical Training Institute (PTI), Institute of Validation Technology (IVT), Barnett International, International Quality and Productivity Center (IQPC), Lunden-Ellow a/b (Euro-GMPs), Puerto Rico Pharmaceutical Quality Assurance (PRPQA), Pharmaceutical Industry Association (PIA), Puerto Rico Chemists Association (PRCA), Puerto Rico Institute of Chemical Engineers, Puerto Rico School of Pharmacy, University of Puerto Rico and other Scientific and Professional Organizations.
Johnny Guerra is an Industry Consultant, Regulatory Compliance, and the President of Guerra Consulting Group, Inc. (GCGI)™. He worked for 20 years at the Food and Drug Administration (FDA), San Juan District Office and held positions such as Acting Science Branch Director, Supervisory Chemist, the District Instrument and Computer Specialist and as a Senior Food and Drug Chemist.
He received his degree in Chemistry certified by the American Chemical Society (ACS) from the University of Puerto Rico, Río Piedras campus and later was certified in Electronics Engineering in Minicomputers and Microprocessor Technology by the Capitol Radio Engineering Institute (CREI), Washington, D.C.
Mr. Guerra has over 42 years of experience in areas such as electronic instrument design, microcomputers, laboratory automation, Local Area Networks (LANs), Quality Assurance, Quality Control and auditing laboratory/manufacturing computerized processes and manufacturing/ laboratory operations at Pharmaceutical, Biotechnology, R&D & Medical Device firms.
He was also member of the FDA Foreign Inspection Cadre where he traveled overseas performing audits in manufacturing processes, quality assurance, manufacturing/laboratory computer validation and analytical methods validation as well.
Mr. Guerra was the Chairperson of FDA’s Automated Data Processing (ADP) Advisory Committee and the FDA Local Area Network (LAN) Committee. The outcome of such work is now reflected in FDA’s nationwide automated frame of operation and the creation of LAN management centers.
"Former FDA Instrument and Computer Specialist”
"Former FDA Supervisory Chemist”