Alejandra Dávila Zamora
PROCESS ENGINEERING EXPERT
Founder of ACeC (2018) with more than 20 years of experience in the pharmaceutical and medical devices industries.
AREAS OF EXPERTISE
Process Engineering, Measurement of Performance Indicators, Implementation of Quality Systems, Start-up and Shutdown of Pharmaceutical Plants, Qualification of Critical Equipment and Systems, Validation of Manufacturing Processes and Cleaning Processes.
Education
Industrial Biochemical Engineer, Autonomous Metropolitan University grad.
Masters in Engineering and Project Management, National Autonomous University of Mexico (UNAM) grad.
Rubén Barragán Flores
VALIDATION EXPERT
Professional with more than 15 years of experience in the pharmaceutical industry.
AREAS OF EXPERTISE
Project Control, Process Validation, Cleaning Validation, Computerized Systems Validation (CSV) and Technology Transfer.
Education
Pharmaceutical Chemist Biologist, National Autonomous University of Mexico (UNAM) grad.
Masters in Industrial Administration, National Autonomous University of Mexico (UNAM) Faculty of Chemistry grad.
José Mar tín Maldonado Rodríguez
EXPERT IN VALIDATION, QUALIFICATION, CSV & PROJECTS
Professional with more than 20 years of experience in the pharmaceutical and pharma-chemical industries.
AREAS OF EXPERTISE
Process Improvement, Qualification, Design and Construction of Facilities, Critical Systems, Process Validation and Cleaning Processes, Computerized Systems Validation, Process Automation and Instrumentation.
Education
Industrial Chemical Engineering, University of the Americas in Puebla grad.
Masters of Science in Chemical Engineering, Technological Institute of Celaya grad.
Carlota Medecigo Micete
EXPERT IN CONTINUOUS IMPROVEMENT AND PRODUCTION
Professional with more than 20 years of experience in the pharmaceutical and medical devices industries.
AREAS OF EXPERTISE
Operations (Manufacturing and Engineering), Lean Manufacturing, Transfers, Projects, Audits and Quality Systems.
EDUCATION
Industrial Pharmaceutical Chemist, National Polytechnic Institute (ENCB) grad.
Masters in Pharmaceutical Sciences, National Polytechnic Institute (ENCB) grad.
CERTIFICATIONS
• Green Belt in Lean Six Sigma accredited by Kimberly Clark
• Certified Quality Auditor accredited by American Society for Quality
• Diploma in Plastic Injection Molding accredited by CONALEP ISO 13485
• Internal Auditing accredited by Quality and Development Associates, Inc.
WORK EXPERIENCE
Bayer de Mexico, Kimberly Clark, Covidien, Danaher.
Ramón H. Mejía Hernández
PHYSICOCHEMICAL LABORATORY EXPERT
Professional with more than 30 years of experience in the pharmaceutical industry.
AREAS OF EXPERTISE
Development, Validation and Transfer of Analytical Methods for the release of product, Product in Processes, Product in Stability, as well as for Cleaning Validation Methods by swabbing method and by rinsing. Qualification of Inspectors in the visual method and the swab sampling method. Implementation and Transfer of Analytical Methods for biotechnological products.
Sergio Hernández Salazar
EXPERT IN AUTOMATION, ENGINEERING AND MAINTENANCE
Professional with more than 20 years of experience in the pharmaceutical industry.
AREAS OF EXPERTISE
Automation, Maintenance in pharmaceutical areas of Manufacturing and CEDIS, Automation, Qualification and Calibration of cold rooms.
EDUCATION
Electrical Engineer, National Polytechnic Institute grad.
Agus tina Flores Colín
QUALITY SYSTEM EXPERT
Professional with more than 25 years of experience in the pharmaceutical and pharmaco-chemical industries.
AREAS OF EXPERTISE
Quality Systems, Good Manufacturing Practices and Good Documentation Practices, Sanitary Responsive, Annual Product Quality Review, Product Release, Physicochemical Analysis and Stabilities of raw material and product, Inspection and Sampling and Statistical Process Control.
José Alberto Celio Sandoval
HUMAN SYSTEMS
AREAS OF EXPERTISE
Continuous improvement of processes, operational excellence, human performance technology and reduction of human error. Human capital management, industrial safety and leadership development. Comprehensive risk management, business continuity and crisis management. In training, facilitation, training management systems and content design.
EDUCATION
Black Belt Certification in Lean – Six Sigma, training and experience in Master Black Belt, Performance Consulting and Ontological Coaching.
WORK EXPERIENCE
General Motors, Syntex and Roche in areas such as Engineering, Operations, IT and Human Resources. Professor by subject at UAEMex on Leadership, Project Management and Design topics.
JOSÉ ANTONIO HUERTAS MIRANDA
GMPS VALIDATION RISK MANAGEMENT AND APPLIED STATISTICS
AREAS OF EXPERTISE
Specialized in the topics of GMP, GLP, Validation, Risk Management and Statistics Applied to the Pharmaceutical Industry.
EDUCATION
Bachelor of Science from the University of Puerto Rico with Credits in Applied Statistics from the Inter-American University of Puerto Rico.
WORK EXPERIENCE
28 years of work experience in the Pharmaceutical Industry in companies such as: Baxter, Rorer and Merck Sharp & Dohme; Consultant and Instructor of Companies such as: Pfizer, Abbott, Bayer, Merck, Roche Syntex Group, Novartis, GlaxoSmithKline, Wyeth, Boehringer Ingelheim, Procter & Gamble, Sandoz, Bristol Mayers Squib, Pisa, Serral, Somar, Silanes, Bioclón, Rayere, Immunological Specialties Laboratories, Pharmaceutical Research Pharmaceutical Laboratory, Birmex, Fandeli, Tornel, Ferring, Volvo, Petstar, Medifarma, Skypharma and Zermat). Instructor of the Tecnológico de Monterrey in Lean Philosophy in Quality”, “ Statistical Process Control ”(from Diploma in Quality Systems) and “Innovation”.
RAFAEL NEVÁREZ NIEVES
FDA INSPECTIONS AND AUDITS
AREAS OF EXPERTISE
Planning, execution and management of technical and complex investigations of drug manufacturing facilities. Regulatory and criminal inspections, specifically related to activities with an impact on data integrity. Compliance with pharmaceutical, veterinary, medical accessories, cosmetics and food supplements exported by Mexican and Guatemalan companies to the US, manufacturers of active ingredients and finished products.
EDUCATION
Bachelor of Science, Chemistry and Biology / M. Science / Former FDA Investigator.
WORK EXPERIENCE
26 years as an Investigator and Compliance Officer for the FDA Food and Drug Administration. During the last 4 years of his career, he served as Deputy Regional Director of the FDA Office in Mexico City.