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ROAD TOUR TOPICS
“How to ensure vendor compliance and mitigate risks of 3rd parties”
Jan Anisimowicz, C&F
“Auditing Vendors with NIST (GRC process)”
Dana Bessey, C&F
“The Validation Process A-Z”
Kevin Marcial, Performance Validation
&
Our Special Guest only in Montreal
“Health Care Vendors & Payment Transparency”
Giri Ratnasingham, LBGR Consulting Inc.
Speakers
Jan Anisimowicz
Director Risk & Compliance Solutions, C&F
Responsible for the AdaptiveGRC Risk & Compliance business line including solution portfolio and go-to-market strategy.
Jan is an IT Manager with 18 years of experience in Data warehousing, Business Intelligence, data analysis, risk, audit and compliance management. Jan is skilled in the areas of System Architecture and Design, Issue Management, and efficient team management. Recently Jan has been very involved in data privacy and lean GDPR processes. Jan currently holds the following certificates: PMP, Prince2, CISM, and CRISC.
Education: Warsaw Military University of Technology, Information Systems & Cybernetics – Master Degree (1999), Kozminsky University: MBA in IT (2007) and Management & Marketing (2008).
Dana Bessey
Senior AdaptiveGRC SME, C&F
Responsible for the US Market as both a Solution Lead and Client Liaison.
Dana aspires to provide practical guidance in the areas of Governance, Risk, and Compliance. Dana has an extensive background is in IT Management, IT Audit, and Risk Assessment. He is also an InfoSec Program Development and NIST subject matter expert and proficient with a vast array of control frameworks and standards such as NIST SP 800-53, NIST RMF, and Cybersecurity Framework. Dana has performed audits of various regulatory standards such as Mars-E, IRS 1075, HIPAA, CJIS, PCI, as well as industry leading practices and resiliency. Dana has hands-on experience with audit logging and monitoring activities, operating systems, and Enterprise Resource Platforms such as Oracle J.D. Edwards, and Sage ERP. Other noteworthy work includes the following areas: ISO 27001-4, CoBIT, COSO, Green Book, CIS 20, Cloud Security Alliance, and FedRamp.
Education: Completion of US Navy Combat Systems Electronics College; Associates equivalent specializing in Technical Data Systems. Dana also served for six years in the US Navy primarily aboard the USS Saipan where he was honorably discharged in 1995.
Kevin Marcial
Services Manager, Performance Validation
Principal Validation Specialist and Computer Systems Validation (CSV).
Kevin Marcial is a Principal Validation Specialist and Computer Systems Validation (CSV) Services Manager at Performance Validation. He has worked in Computer Systems Validation for the over ten years, supporting FDA regulated projects for Research, Pharmaceutical, and Medical Device organizations. He provides project leadership, client service delivery (i.e. consultation, document development), and business development oversight/execution for Performance Validation. His experience has allowed him to develop and execute validations for a wide-variety of system types including ERP, LIMS, lab instrumentation, document management, and electronic QMS. Kevin also has experience in general FDA system compliance, such as system risk, software vendor, 21 CFR Part 11, and data integrity assessment. Kevin enjoys helping clients develop new CSV programs and helping them find the most efficient and compliant way to complete their projects.
Giri Ratnasingham
Director, LBGR Consulting Inc.
Payment Disclosure – Transparency Reporting Consultant.
Giri is a Commercial Operations Executive with extensive experience in the Pharmaceutical industry, commercial operations and IT. Lead all aspects of Commercial operations, recognized for developing and implementing strategies to drive business results. Significant IT knowledge and experience, known for leveraging IT to achieve organizational success. An accomplished project manager, lead multiple global and national projects including mergers and acquisitions, ERP and CRM implementations. An experienced leader, recognized for creating and sustaining high performing teams. Giri has been in the pharmaceutical industry for over 30 years, starting his career at Merck Frosst Canada in 1989, as an IT program and subsequently supporting Merck Frosst ERP platforms. As the technology professional, Giri had an opportunity to work with the numerous business unit divisions including HR, Legal, Finance, Sales (CRM), Marketing and Manufacturing.
Education: B.Sc. degree in honours Biochemistry from University of Alberta and a Computer Science degree, from University of Victoria. Giri also served in the Canadian militia with the Princess Patricia’s Canadian Light Infantry (PPCLI).
ORGANIZERS
