MEET LSTI'S INSTRUCTORS

Employing The Brightest Minds In The Life Science Industry

At LSTI, we believe the success of any training program begins with the selection of the right instructor. Simply put, we only hire the best in the business. Our trainers blend the right mix of subject matter expertise, instructional experience, and relevance in industry. Some of our instructors are highlighted below.

Pharmaceutical GXP Training Instructor

Joanna Gallant is an experienced, solutions-driven Quality professional with over 20 years of technical and operational experience within pharmaceutical, biotechnology and medical device manufacturing environments. Over her career she has provided regulatory, technical, skill and management development training support to all Operations functions as well as IT, R&D, Customer Service and senior management.

Joanna has held positions in quality assurance, laboratory and training roles. She has established and led multifunctional and global project teams, and worked both as an individual contributor and a manager, and can speak from various perspectives as a result. She is well versed in instructional systems design and possesses highly efficient analytical problem solving and root cause analysis skills, which she uses to identify problems and solutions for performance and process improvement, and to analyze training systems for gaps and training programs for effectiveness.

Clinical Quality Systems Training Instructor

Sandra “SAM” Sather is an industry-leading consultant whose mission is to promote clinical quality systems for Sponsors/CROs and Investigators/Research Institutions. She has over 25 years of clinical experience, with a Bachelor of Science in Nursing and a Master of Science in Education with a Specialization in Training and Performance Improvement. SAM is the vice-president of Clinical Pathways, a consulting firm located in the Research Triangle Park area in North Carolina, USA. SAM is dual certified by the Association for Clinical Research Professionals (ACRP) for over 10 years (CCRA and CCRC) and a current member of the ACRP Academy Board of Trustees and Regulatory Affairs Committee (RAC). She is a frequent speaker for industry conferences and has authored dozens of courses for clinical research in various functional areas (e.g., monitoring, safety, HIPAA, and vendor management).

software implementation and compliance Training Instructor

Alecia Adams, RQAP-GLP, PMP, ASQ CSQE, is a software implementation and compliance consultant and the founder of Compliant Systems Services, LLC, located in Charlotte, NC. She helps biotechnology, pharmaceutical, and medical device companies find and implement computerized systems that increase efficiency, sustain compliance, and ease business pain. Ms. Adams has 18 years of combined experience in technical operations, quality assurance, and information technology. She earned her B.S. in Biochemistry from the University of Southern Mississippi and is continuing her education at the Johns Hopkins University, where she is earning her M.S. in Bioinformatics and focusing on the potential of big data and cloud computing in the area of personalized medicine. She is a member of the American Society for Quality (ASQ) as well as the Society of Quality Assurance (SQA) and its Computer Systems Validation Initiative Committee (CVIC).

CGMP Compliance Training Instructor

Thomas J Pritchett, Ph.D., has worked with US, European, and Canadian pharmaceutical,biopharmaceutical, and biologics industries for more than 25 years, during which he has gained considerable experience in regulatory and technical aspects of Quality Assurance, Quality Control and CGMP Compliance for both investigational and marketed products. He is also an experienced teacher, and has been directing courses for the Center for Professional Advancement since 1995. In addition, Dr. Pritchett has provided training sessions for the US FDA and for regulators and industry professionals in the Gulf Cooperation Council (GCC). Dr. Pritchett is also an active industry consultant and the co-founder/publisher of the newsletter BioQuality.

Clinical GCP/SOP Training Instructor

For over 10 years, Michael Pierro has provided consulting services to the Biotechnology, CRO and Pharmaceutical Industry in the areas of clinical operations (Standard Operating Procedures, Project Management and Clinical QA GCP auditing) and GCP/SOP training (live & Internet delivery). In this work, he draws on over 30 years of experience in clinical operations and training in the pharmaceutical & biotechnology industry.

Previously employed by Barnett International, Michael served as Director, Business Development: Consulting & Clinical Training responsible for development and implementation of GCP related standard operating procedures, specialized compliance related training programs and related consulting services. Clients include Pharmaceutical, Biotechnology, CROs, University Medical Centers and US Federal Government. Immediately prior to joining Barnett, Michael was Director of Global Training for Hoechst Marion Roussel’s (Aventis) Global Clinical Quality Assurance Department.

Quality & Regulatory Compliance Training Instructor

Marcelo Trevino is an Experienced Quality & Regulatory Compliance Senior Manager with Medtronic in the Medtronic Heart Valves Center of Excellence/Cardiac & Vascular Group.

Mr. Trevino has an extensive knowledge of Medical Device Management Systems: ISO 13485:2003 & International Medical Device Regulations: USA (FDA QSR), Australia (Therapeutic Goods, Medical Devices Regulations), Canada (SOR/98-282 & Canadian Medical Devices Conformity Assessment System (CMDCAS), Japan (Pharmaceutical Affairs Law), Europe (93/42/EEC Medical Device Directives).

He holds a Bachelor of Science in Industrial and Systems Engineering from ITESM in Mexico and an MBA in Supply Chain Management from the W.P Carey School of Business at Arizona State University.

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