Our team is led by CSV Expert Deb Bartel, and CSV Expert Rodrigo Perez. They bring over 50 combined years of Computer System Validation experience in the regulated life sciences industry.
Deb Bartel
Deb teaches practical, effective approaches to meet the quality and compliance challenges of the Life Sciences industry. Deb’s expertise is built on 25 years of work in pharmaceuticals, medical device, chemicals, and textile manufacturing industries.
She holds ASQ certifications in quality auditing (CQA) and six-sigma processes (CSSGB) as well as a PMP® from the Project Management Institute. Deb has BS-Information Systems and MBA degrees from the University of Wisconsin.
Rodrigo Perez
Rodrigo brings over 34 years of experience in validation for both medical devices and pharmaceuticals. Rodrigo trains professionals in computer system validation using a risk-based approach.
He is a Computer Systems Validation Manager, working on and managing software validation and software quality assurance projects for our customers. He is qualified in Transactional Six-Sigma (TSSGB) and has a bachelor’s degree in Computer Science – Software Engineering from Weber State University.
Fred Wiles
Fred brings over 30 years of experience in validation and quality engineering. Fred helps clients with highly technical projects and initiatives in the Medical Device, Pharmaceutical, and Biologics industries.
He is a Principal Validation Consultant, working on and managing equipment and process validation projects for our customers. He holds an ASQ certification in quality engineering (CQE).
Bob Verhoeff
Bob brings over 23 years of experience in commissioning, qualification, and validation (CQV). He has served as an IT compliance specialist and Validation engineer and is recently working as CSV Lead auditor in regulated environments at Medical Device and Pharmaceutical companies in international context.
As a practitioner and technologist, Bob has performed validation resiliency projects and Data Integrity assessments to define the IT readiness for drug product and medical device launches.
John Gow
John has been actively working in the pharmaceutical industry for the past 30 years, with international experience in the UK, Europe, and the US. His experience covers laboratory analysis, process validation, and Pharmaceutical Quality Assurance with a specific focus on Risk-Based Computer System Validation.
He is a Senior Consultant, specializing in Data Integrity and Computer System Validation, and brings a wide range of experience to help students grow their validation skills and get inspection-ready.
Our Approach to Computer System Validation Training
- Our computer system validation and software quality consultants have extensive experience in providing leadership to companies seeking to meet regulatory expectations.
- We have developed educational courses and webinars that help you apply the FDA, ICH, and Eudralex risk-based validation concepts to your projects to maximize the impact of your compliance and quality efforts.
- Our courses also incorporate industry standards and best practices, such as those found in PIC/S and GAMP.
