Kamila Novak holds MSc in molecular genetics. She has been involved in clinical research since 1995, having worked in various positions in pharma and CROs. Since 2010, she has been working as an independent consultant and incorporated in 2019. Her business activities include auditing, SME consulting for QMS establishment and process improvements, medical writing, and training. Kamila is a certified Lead Auditor for ISO 9001, ISO 31000, ISO 13485, and ISO 15189, a trained auditor for ISO 14155, cGMP-QMS, and GXP. She is a member of the EMWA, the DIA, the CPD UK, the SQA, the Association for GXP Excellence, the WMDO, and other professional societies. In the SQA, she is the Chair of the Beyond Compliance Specialty Section.

Natalie Custer is a Senior Manager, Technology Quality Assurance at Advarra. In this role she consults with Advarra IT and operations. Natalie has over 25 years’ experience in QA, validation services and software development.

Tracy DeVan Henthorn is a Safety Assessment Computer Validation QA Specialist at Charles River Labs with over 22 years in the quality field. She holds an AA degree from Ohio State University, specializing in chemistry and biology, and has completed additional animal-related coursework at Ashland University. Tracy is an RQAP-GLP holder since 2007 and actively participates in MWSQA and SQA. With expertise in facility audits, she mentored QA staff and facilitated sponsor audits in her previous role. Tracy recently transitioned to a QA representative for computerized system validation, assisting sites with validation projects and providing global validation expertise at Charles River.

Maria Kellner is the President Virtua Pharma and holds master’s degrees from Temple University in Regulatory Affairs and Quality Assurance and University of Pennsylvania in Telecommunications. Her background includes working in CROs, pharmaceutical companies, and a clinical trial software development enterprise, and she played a key management role in the largest pharmaceutical and CRO data exchange initiative to date. Since 2015, she has been running her own consulting company, Virtua Pharma Technology. Maria is in the process of transforming Virtua Pharma Technology into a ‘Validation as a Service’ company. Her interest in computer system validation comes from her years spent as a developer as well as her love for process improvements!

Richard Siconolfi is retired after 42 years, where he spent the last 31 years working for Procter & Gamble as a Director of Computer System Validation for P&G’s regulated products. Since retiring in 2019, he has been a consultant to the pharmaceutical industry where he conducts scientific audits and manages computer system validation events and projects. He earned a BS in Biology and MS degree in Toxicology. He is a co-founder of the Society of Quality Assurance. Richie was awarded the designation of Fellow by the Research Quality Assurance society in 2014.

Anu Virkar, PMP, has worked in the medical device and clinical trial management industry for over 25 years and has progressively taken on more challenging roles and has delivered successfully on these challenges. Her accomplishments have included the establishment of a high-quality regulatory compliance programs. She has implemented quality management systems to improve services and product suites in device and drug manufacturing as well as clinical environment. She has guided the processes for getting ISO certification for system development and operations by utilizing her skills, experience, and perseverance.