Life Sciences companies face the challenge of producing the documentation required for validation of software in order to comply with regulatory expectations as prescribed by international regulatory agencies such as the US Food and Drug Administration (FDA), European Medicines Agency (EMA), UK Medicines and Healthcare products Regulatory Agency (MHRA) and others. The SAP S/4HANA Validation: A Streamlined Approach webinar will demonstrate how companies can meet regulatory requirements, shorten the overall time frame and reduce the burden on staff, while also ensuring ongoing compliance through the use of an SAP Validation Compliance Package.
Vice President, Sales & Marketing, Arbour Group LLC
Archie O'Leary is Sr. Vice President, Sales & Marketing for Arbour Group, a global provider of regulatory products and services for life sciences companies. He has served in this capacity for 17 years and has gained significant experience with the interpretation and application of regulatory requirements for software compliance as stipulated by the U.S. Food and Drug Administration (FDA) and other international agencies. He has practical experience with regulatory topics that include 21 CFR Part 11, risk management, cloud compliance, supplier compliance and procedural controls.
Prior to Arbour Group, Archie worked for 20+ years in manufacturing environments where he served in capacities to include Program Manager - Process Optimization, Project Manager - Systems Implementation and Sales Executive.
Director of Sales Computer System Validation, Europe, Arbour Group LLC
Christopher is the Director of Sales Computer System Validation, Europe and he is committed to providing the best products and services to both European clients and partners. With over 25 years’ experience working within the Life Sciences, Compliance and Software worlds in Commercial, Operational, Professional Services and Project Management roles, Christopher offers keen insight into where Life Sciences, compliance and technology meet.