About Validation Center

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.

Deb is a long-time leader of software quality and information system initiatives. Her expertise is built on 25 years of work in pharmaceuticals, medical device, chemicals, and textile manufacturing industries.

Deb Bartel teaches practical, effective approaches to meet the quality and compliance challenges of the Life Sciences industry. She utilizes LEAN, continuous improvement, and risk-based processes to reduce costs while maintaining compliance with both US and international regulatory agency expectations. Deb also has many years of experience managing international ERP, laboratory, pharmacovigilance, clinical, quality management, and financial systems projects in both regulated and non-regulated industries.

Since 2007, Deb has trained hundreds of Life Sciences professionals in risk-based computer system validation.

Deb Bartel is responsible for the Computer System Validation (CSV) and Software Quality Assurance (SQA) practice. 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.

Rodrigo has been performing various types of validation, including computer systems validation, process, equipment, and others for over 34 years in both medical devices and pharmaceuticals.

Rodrigo Perez utilizes the excellent course materials we have developed to train professionals in computer systems validation. He teaches you to use a risk-based approach to determine the appropriate level of validation required for each individual system. This approach not only saves time and effort but complies with both U.S. and International regulatory requirements. Rodrigo works exclusively in the regulated life sciences industry. He has managed validations for everything from very small simple projects through complex multi-million-dollar systems.

Rodrigo joined our team in the summer of 2017. He enjoys sharing his experience in computer systems validation with those just embarking in the field.

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.

Frederick 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).

Frederick has been performing various types of equipment and process validation projects for over 30 years in the medical device, pharmaceutical, and biologics industries.

Frederick Wiles uses his extensive knowledge in regulatory compliance (cGMP and QSR) and industry standards to help clients with their highly technical projects and initiatives. He began his career as a metrologist developing measurement standards for analytical method and environmental monitoring instrumentation. Soon after, Frederick’s career path shifted to validation and quality engineering.

As a quality engineer, Frederick has contributed his strong statistical and mathematical background to helping clients with complex projects such as characterization and validation of both discrete and batch manufacturing processes, statistical analysis of critical-to-quality product data, and implementation of statistical process control methods and techniques.

Frederick has written numerous articles on the application of statistics for measurement systems and process validation.

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).

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.

John is a Senior Consultant for Data Integrity and Computer System Validation working in the Life Sciences Consultancy (LSC) Department of ProPharma based in the Berlin Office.

He has been actively involved in the pharmaceutical industry for the past 30 years with international experience in the UK, Europe, and the USA. His experience covers laboratory analysis, process validation, and Pharmaceutical Quality Assurance with a specific focus on Risk-Based Computer System Validation.  John holds a Post Graduate Diploma (PGDip) in Industrial Pharmaceutical Studies from the University of Brighton.

John is an experienced Project Manager with a demonstrated history of working in the pharmaceuticals industry.  Skilled in U.S. Food and Drug Administration (FDA), Validation, Quality Assurance, Quality System, and Verification and Validation (V&V), John has experience on a wide range of pharmaceutical projects ranging from corporate SAP implementations and upgrades, COTS applications, analytical and manufacturing systems, and Data Center Infrastructure qualification. He has additional experience in Supplier Audits, internal audits, and in site preparation for regulatory inspections. In this regard, he has provided focused training in computer system validation and inspection readiness.

Esra Guven

Esra is a results-driven professional with over 25 years of experience in Computer Systems Validation (CSV), Data Integrity, Software Quality Assurance, and IT Regulatory Compliance within the Life Sciences Industry.

Esra held management positions in the pharmaceutical industry on Computer Systems Validation and Quality Assurance performing various types of CSV work and auditing.

She holds ASQ Six Sigma Green Belt certification (CSSGB) as well as a PMP^® from the Project Management Institute. Esra has a Bachelor of Science in Electronics Engineering from Hacettepe University and Computer Systems Analyst degrees from Humber College.

Esra has led and managed a successful global Computer Systems Validation and IT Quality program for over 20 years. Supported  in-depth understanding of FDA 21 CFR Part 11 Electronic Records and Electronic Signatures, coupled with a track record of successful Data Integrity remediation efforts. Throughout her career, Esra utilized Agile and Lean validation as well as Digital CSV. Esra lowered costs and timeline of Computer Systems Validation projects, improved software quality while retaining compliance with international regulatory requirements and standards including Part 11, EU Annex 11, GAMP5, PIC/S.

Esra has been performing various types of computer systems validation including, quality, Laboratory systems, clinical software, Enterprise-wide systems, manufacturing, infrastructure systems and AI solutions in Life Sciences.

She successfully presented and defended GxP Computer systems validation, Data Integrity program and quality systems during regulatory audits (Examples: FDA, Health Canada, EMA, MHRA), internal corporate audits, customer audits resulting NO observations. She would like to share her experience on how to pass regulatory inspections in the area of Quality Management Framework, Compliance, CSV, Data Integrity.

Additionally, Esra has led and conducted CSV, GCP, Data Integrity, 21 CFR Part 11 audits for companies including pharmaceutical, biotechnology, clinical, and software/infrastructure vendors.

She holds ASQ Six Sigma Green Belt certification (CSSGB) as well as a PMP® from the Project Management Institute. Esra has a Bachelor of Science in Electronics Engineering from Hacettepe University and Computer Systems Analyst degrees from Humber College.