About Us

Our Philosophy

Pharma Serv Academy offers an educational program to produce, share and communicate technical courses within a team-setting environment.

Pharma Serv Academy has trained major Pharmaceutical, Medical Devices and Biotech companies in US, Europe and Latin America.

Our objective is to enrich understanding of theoretical and practical elements in key skills required in the Pharmaceutical, Biotechnology, Medical Devices, Information Technology, Insurance, Finance, and Food Industries, among others. Our resources are Senior Level well experienced professionals. We are always in continuous development of our training programs through training tailored to your organization specific needs. Pharma Serv Academy offers hands-on workshops, boot camps and certifications programs addressing the industry latest trends and regulations.

Our courses can be offered in English or Spanish, at you site at your convenience. We can design the course of your choice and tailor it to your specific requirements.



Pharma Serv Academy courses are accredited for continuing education, for more information please contact your professional certification program.

Testimonials

"I know from the feedback from my colleagues that the training last week was excellent. They learned a lot. - HPRA Health Products Regulatory Authority

"Many thanks for the training. I found the two days to be very well organized and informative" - HPRA Health Products Regulatory Authority

Our Valuable Team Members & Facilitators

Víctor Sánchez

President & CEO, Pharma-Bio Serv,    Puerto Rico Operations

Víctor has been working in the Life Sciences industry since 1996 in the United States, Puerto Rico and Europe.  Víctor is a Puerto Rico Licensed Chemist, has a Master¹s degree in Business Administration in Industrial Management, and holds a postgraduate diploma in Validation Pharmaceutical Technology.  He is certified as RAPS Regulatory Affairs Professional for the US market.  Mr. Sánchez is currently President and CEO of Pharma-Bio Serv.  He is a subject matter expert in various technical subjects, such as, Root Cause Analysis, Investigations, Quality Risk Management, and other compliance disciplines. Víctor currently provides training to several European Health Regulatory Agencies and to different post graduate programs in Spanish Institutions.

Myrna Orama

Director of Puerto Rico Operations

Myrna is an SME in Project Management, Quality Risk Management, Risk-Based Commissioning & Qualification, Computer System Validation, Laboratory Systems, and Regulatory Compliance.  She has worked for customers in PR, US and Europe providing customized solutions in her areas of expertise.  Myrna is knowledgeable in the majority of ICH Guidelines related to Quality Risk Management, ISPE Risk-MaPP Baseline® Guide, ISPE GAMP® 5 and ASTM E2500, amongst many others.  Mrs. Orama is currently the Director of Puerto Rico Operations at Pharma-Bio Serv PR, Inc. She holds a Bachelors degree in Chemical Engineering from the University of Puerto Rico Mayagüez Campus and a Masters Degree in Environmental Management from the Metropolitan University at San Juan, Puerto Rico.  

Leo R. Cabranes

Pharma Serv Academy Business Leader / Sr. Consultant

Leo has over 15 years of experience in Quality, Technical Services, and Validations for Pharmaceutical, Biotechnology and Medical Devices companies such as Astrazeneca, Bristol-Myers Squibb, Johnson & Johnson, Schering-Plough, Wyeth, Lilly, Bausch + Lomb, St. Jude Medical, Medtronic and Amgen. He has a BBA in Industrial Engineering from the University of PR, Mayagüez Campus and a Master's degree from the Polytechnic University of Puerto Rico, specializing in Pharmaceutical Products Technology. He has vast experience in Clean Room aseptic techniques and Human behavior inside controlled environments. He has experience working with FDA, EMA & ISO audits. In addition, is ASQ certified as CQE and Lean Six Sigma Green Belt. 

Magaly Aham

Vice President, Pharma-Bio Serv US Operations

Magaly holds a Bachelors Degree in Chemistry from the University of Puerto Rico and a Master Degree in Bioscience and Regulatory Affairs from the Johns Hopkins University in Maryland, US. She has comprehensive management experience in Quality Assurance, Quality Systems, Compliance, Quality Control, Validation and Manufacturing Operations. Magaly has participated as a lead in companies undergoing remediation efforts such as Consent Decrees and Warning letter environments in which she has developed expertise in quality systems design and implementation. She is Kepner-Tregoe PSDM Certified, a Certified Trainer, former ASQ Quality Auditor (CQA) and a Licensed Chemist. She is a PDA, ISPE and RASP active member and a committee member for the Delaware Valley PDA and ISPE local chapters.


Marilivette Curet

Business Developer, Pharma-Bio Serv

Marilivette is a professional with solid experience in the areas of Commissioning and Qualification, quality assurance, quality control, and microbiology laboratories under a Warning Letters action plan and Consent Decrees. Collaborator during water system validation for Parenteral and Chemical Plant, Manufacturing Equipment, Facilities and Utilities Commissioning and Qualification for Solid Dosage Plant. Experience designing, implementing and managing quality systems as Investigations and CAPA. Executing protocols, investigating, supporting audits and all the activities related to summary reports during Biotechnology Plant Start-up. Direct participation in Consent Decree and Remediation projects in several GMP facilities. Ethically driven, excellent interpersonal, leadership, team work and technical writing skills.


César Mirabal

Metrologix Business Developer

César advises life sciences organizations on how to achieve value through regulatory compliance. He has an engineering background coupled with certifications as Six Sigma Black Belt and Certified Manager of Quality/Operational Excellence, and over 20 years of experience in project management, validation, and regulatory compliance, quality assurance, calibration & maintenance and continuous improvement. He has extensive experience with facilities, utilities, manufacturing equipment and support systems, including computer system validation, technology transfer, commissioning, start-up, qualification and validation. His previous experience at Bayer AG, Alcon Laboratories, Johnson and Johnson, Mentor Technical Group and PSC Biotech includes roles as Engineer, Supervisor, Manager, Director, General Manager and Managing Director.  


Wilmarie Pérez

Sr. Validation & Compliance Specialist, Pharma-Bio Serv

SME with proven experience in project management, statistical analysis, validations, manufacturing and packaging in solid, semi solid and liquid dosages pharmaceutical products.  Knowledge on Quality Risk Management and Risk Based Approach to Cleaning ValidationValidation experience covers project management, technology transfer, process development/scale-up/validation of pharmaceutical manufacturing/packaging processes, manual and automatic cleaning procedures development and validation, bulk holding time studies, investigations, performance qualification, product/process characterization, new product development and validation.  Proven background in scheduling, troubleshooting, registration, audits/assessments, preparation of validation documentation, strategies, mater plans, and all related regulatory documentation required for FDA approval.