Validation Academy Faculty


Magaly Vega Fuego, PhD, RPh

Magaly Vega has a Ph D in Industrial Pharmacy. She has over thirty (30) years of experience in the pharmaceutical industry in the areas of research, validation, Technical Services, manufacturing/packaging, compliance, and Engineering; and had oversee the start-up, and validation, of seven (7) mayor manufacturing plants. Her experience covers the manufacturing, validation, and technology transfer of parenteral, solid, liquid and semi-solid dosage forms. She was in charge of starting the validation program for The Upjohn Co at Kalamazoo, MI, and Puerto Rico She has occupied department management positions in manufacturing/packaging, technical services/validation and engineering. She serves on the faculty of the Polytechnic University as a part time professor and the PRPQA steering committee and is the Coordinator of this Certification in Validation. 

Carroll Díaz Hernández, MEME – Phcom Consulting Group / Senior Consultant

Over twelve years of experience in the industry in areas related to validation, technology transfer, project management and quality/process engineering. Occupied positions as Product Development Engineer, Validation/Process Engineer, Technology Transfer Coordinator, and Validation Manager, among others. Involved in projects related with facility start-up for parenterals and solid dosage forms manufacturing facilities. Participated as a speaker in forums such as INDUNIV, Chemist’s Colleague, ISPE providing seminars related with Commissioning, Validation, and Technology Transfer topics. Active part-time professor at the Polytechnic University of PR providing support with the Process Validation & Technology Transfer and Probability & Statistics for Engineers Courses, after completing her Master Degree in Manufacturing Engineering. Member of the ISPE, PDA, Institute of Validation Technology, and American Society for Quality. 

José E. Correa PE, MBA

Mr. Correa is a Professional Engineer with a Bachelors Degree in Computer Engineering and a Masters in Business Administration with concentration in E-Business. His academic background is combined with over sixteen years of functional and managerial experience in the Pharmaceuticals and Medical Devices industries where he has held leadership positions in manufacturing, engineering and technical services in multi-site facilities. 
Mr. Correa has participated in international transfer of operations where his role has been to lead the project from conception to validations. As such was his leadership role in the transfer of an operation from Taiwan ROC to PR and later on, the transfer of a full manufacturing operation from PR to Delaware. Earlier in his career he led commissioning and validation efforts for a Building Management System installed at an Oral Solids Dosage facility. He also participated in facility and process validation efforts for a Medical Devices Operation. During his tenure as Packaging Operations Manager he was accountable for the packaging line revalidation. 
Most recently he has participated in providing consulting to the industry in Computer System Validations (CSV) and 21 CFR Part 11. He is currently the Vice President and General Manager of a consulting business that specializes in providing assessment and remediation services in computer system validation and 21 CFR Part 11. The company also performs system implementations, cleaning validations, process validations and facility validations. He manages operations in PR which extend to Miami and Mexico. 
Mr. Correa has been speaker in CSV and Part 11 seminars at the College of Engineers and Surveyors of PR (CIAPR). He has also been a speaker in the same subject at the Polytechnic University of Puerto Rico. He contributes to the development of fellow engineers by contributing with CSV articles in the CIAPR’s technical publication, “Tecnomundo”. He is also part of an Engineering Curriculum Development Team for the Polytechnic University of Puerto Rico. 
Mr. Correa is an active member of the College of Engineers and Surveyors of PR (CIAPR), where he holds the position of Director at the Institute of Computer Engineers (IICOM). 

Nelida Plaza, BSChE, MSEM

Nelida Plaza is a Chemical Engineer with a Masters Degree with over 16 years of experience in the Pharmaceutical, Medical Devices and Chemical industry. Her technical background comprises project management and execution of technology transfers, cleaning validations, process and packaging validations, process support in the manufacturing and packaging of solid, liquid and semi-solid dosage products, investigations, corrective/preventive action plans, raw material and API qualifications, regulatory compliance assessments, technical documentation, process engineering support, SOP’s, master batch records, risk assessments, audit/assessments reports, supplier qualifications, production improvement projects, Pre-Approval Inspections readiness process, technical service support in the development, filing, and manufacturing of new products. Her background and experience also includes Safety, Health and Environmental areas. In the areas of cleaning validation, Nelida has strong hands-on experience in the development of Cleaning Validation Master Plans, Training, preparation and execution of cleaning validation protocols and reports, acceptance criteria determination, cleaning verification and process capability studies, among others.

Elizabeth Plaza, RPh

Elizabeth has over eighteen (18) years of experience in the areas of technology transfer, project management, validations, regulatory compliance, quality assurance, quality control, manufacturing and packaging in solid dosage and Parenteral Pharmaceutical Industries. Her validation and regulatory compliance experience covers department management, project management, facilities, utilities, equipment/systems, computer system validation, commissioning, startup, qualification (IOP/Q). Also, troubleshooting, registration, process validation of pharmaceutical manufacturing/packaging processes, audits/assessments, preparation of validation documentation, and all related regulatory documentation required for FDA approval or certification of facilities.

Heriberto Lorenzo, BSIE

Over twelve years of experience in the Healthcare Industry in areas related to Quality Assurance, Quality Engineering, Validation, Project Management, Manufacturing Operations, Strategic Supplier Management and Industrial Engineering. His contribution as Lead Quality Auditor, Quality Operations Engineer, Process Development Engineer, Manufacturing Operations Manager and WW Procurement Engineering Leader has been awarded in several industries in P.R. Involved in projects related with facility start-up for medical devices and parenteral facilities. Leader for the development and implementation of quality systems, supplier quality assessment programs and process improvements in the industry. Member of the ISPE and the American Society for Quality. 

Eng. Carlos Urrutia, ET, BSME

Over thirteen years of experience working in diversified industries as electrical, metallurgy, food manufacturing and medical devices involve in areas related to validation, technology transfer, quality control, project management, manufacturing and process engineering. Carlos has occupied positions as Manufacturing Engineer, Validation/Process Engineer, Project Manager, HACCP Team and Lean Sigma Leader, among others. His experience covers project management, HACCP program, facilities, utilities, equipment/systems, computer system validation, commissioning, qualifications (IQ, OQ & PQ), product/process validation (medical devices) and risk management.