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External Consultants

alejandra
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.

CERTIFICATIONS

• General Consultant accredited by CONOCER
• Instructor of courses to face-to-face groups accredited by CONOCER
• Course Design accredited by CONOCER

WORK EXPERIENCE

Roche Mexico, Beckton Dickinson, Bayer de Mexico, Merck Sharp & Dome

ruben
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.

 
WORK EXPERIENCE

Roche Mexico, Bayer of Mexico, Boehringer Ingelheim

jose martin
José Martín 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.

CERTIFICATIONS

• Project Director accredited by the Project Management Institute (PMI)
• Instructor of courses to face-to-face groups accredited by CONOCER
• Course Design accredited by CONOCER
• General Consultant accredited by CONOCER

WORK EXPERIENCE

Roche Mexico, Syntex, Merck Sharp & Dome

carlota
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.

ramon
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.

EDUCATION

Food Chemist, Autonomous University of the State of Mexico grad.

WORK EXPERIENCE

Signa-Apotex, Roche Mexico, Lakeside

sergio
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.

Experiencia laboral

Bayer de Mexico, Honeywell

agustina
Agustina 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.

EDUCATION

Pharmaceutical Chemist Biologist, Autonomous University of the State of Mexico grad.
Masters in Engineering, Autonomous University of the State of Mexico grad.

Experiencia Laboral

Signa-Apotex, Roche México, Lakeside

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.