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President, GUERRA Consulting Group, Inc.©
BenAstrum Expert Affiliate
Biography: Currently the President of Guerra Consulting Group Inc., Lic. Johnny Guerra spent 20 years working for the FDA, holding such prestigious positions as Acting Science Branch Director and Supervisory Chemist. During his tenure with the FDA, Lic. Guerra earned countless accolades including:
• Being selected as a member of the FDA Foreign Inspection Cadre, where he traveled overseas performing audits in manufacturing processes, quality assurance and quality control, as well as computer and analytical methods validation
• Received hundreds of awards and commendation letters for speeches and training, seminar development, publications, project management and managerial abilities
• FDA Commendable Service Award for outstanding performance in the development of the automation process for FDA’s nationwide field offices In addition to his extensive work experience, Lic. Guerra has authored hundreds of technical papers, reports and course manuals for reputable institutes including the Parenteral Drug Association (PDA) and Institute of Validation Technology (IVT), spanning such topics as method validation, GMPs in the chemistry laboratory, quality assurance, quality control, laboratory computer validation and instrument design. He has also published articles for Pharmaceutical Technology and FDA’s internal scientific journal.
Guerra Consulting Group, Inc.
Lic. Johnny Guerra, President, brings close to 30 years of industry experience in areas such as electronic instrument design, microcomputers, laboratory automation, Local Area Networks (LAN), quality assurance, quality control, and auditing of computerized processes and operations for pharmaceutical, biotech, R&D and medical device firms. The Guerra Consulting Group has experience consulting worldwide, providing the Pharmaceutical, Biotechnology, R&D and Medical Device industries with FDA-related regulatory expertise in:
• The design and implementation of laboratory & manufacturing failure investigations and quality event programs including deviations related to consumer complaints, line clearance, mix-ups, mix-labels and short fill situations
• Responding to FDA-483s and Untitled/Warning letters
• Executing Part 11 (Electronic Records; Electronic Signatures) Risk Assessment/GAP analysis, computer systems validation (CSV) and Vendor/Laboratory/Computer certification programs
• Computer and software validation Upcoming Web Seminars hosted by Johnny:
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