Marc Monette
Mr. Monette addresses hundreds of men and women each year on GxP data integrity and key aspects of quality, audit effectiveness, cost of quality, and the development of scalable IT-enabled business processes in the life sciences. As an experienced quality professional, he works to support and influence organizations in their quest to maintain agility, efficiency and effectiveness through a well-seasoned process approach, working through key stakeholders to enable strategies that facilitate the right-sizing of effort. He has worked in Asia (primarily China, India), Europe, Canada, and the Untied States, consulting with all sizes and types of organizations.
Thomas Schultze
Thomas Schultze has over 20 years of experience in pharmaceutical, biotechnology, medical device, financial, and other quality-driven industries. He is a systems architect and subject matter expert on quality management systems, compliance, and systems security. He specializes in consulting on key aspects of systems development and management, cyber security, and data integrity.
Thomas is an established auditor and expert in regulatory and standards compliance, including FDA/EMA regulated computerized system validation (CSV). He is a Certified Information Systems Security Professional (CISSP) and supports clients in North America, Europe, and Asia.
Agust Jansen
Ms. Jansen has worked for over 29 years within the Pharma industry to provide services leveraging her experience in computer system validation and quality assurance. Services provided to her clients include requirements development/building, development of a risk-based approach to validation and testing, validation planning and reporting, test script writing and execution, data migration planning and execution, and providing a thorough QA review of cloud vendor-provided validation documentation, as required. Ms. Jansen also supports development of system intended use through the review and/or writing of standard operating procedures and process workflows according to internal company documentation, industry standards, and FDA regulations. Because of her ability to understand intended use requirements and their relationship to functional requirements and system configuration, she works well to bring team players together in developing the validation strategy and forward momentum required for a successful project’s conclusion. Her familiarity with the process for validation of enterprise systems, databases, laboratory equipment/instruments, and manufacturing equipment allows her to provide the support needed in a typical GxP environment. Knowledge of predicate rules and 21 CFR Part 11 have assisted her in performing thorough assessments of computerized systems’ compliance in the FDA-regulated environment.