How automation can accelerate the timeline for upgrades with a comprehensive suite of software solutions that streamline impact assessments and drive changes in validation scripts based on the outcome of those assessments.
Computer systems validation (CSV) has long been a regulatory necessity but is considered time and resource-consuming to execute. Traditional validation processes present challenges since they extend project timeline and costs, impacting time to market, resulting in an inability for life sciences organizations to promptly deploy newer versions of the software.
In this webinar, learn how the utilization of automation can transform the CSV process for your QMS:
As Senior Director of Product and Strategy within the Technology Solutions business of IQVIA, Michael King is responsible for ensuring that the Medical Device solutions have the necessary functionality to support the increasingly complex and diverse global regulations. He is particularly focused on optimising business workflows through intelligence driven simplification and automation within and across the Safety, Regulatory and Quality functions. Michael has over 15 years of knowledge and experience leading localised and global teams in Regulatory Affairs and Quality Assurance and has worked within the Medical and Surgical, Orthopaedic, In Vitro Diagnostic, Diagnostic Imaging, Dental and Urology sectors. Before joining IQVIA Michael was the Vice President of International Regulatory Affairs for a Dental Technology organisation and had oversight of the International Product Registration, Adverse Event Reporting and country-based Quality Management Systems. Michael holds a degree in Physics from Oxford University and briefly worked for a consulting firm in the telecommunications industry prior to beginning his career in the Medical Industry.
Anthony Hudson has devoted his career to the delivery of best of breed quality systems and processes to support the life sciences industry. Anthony has over 25 years of experience covering electronic Quality Management Systems (eQMS), Program and Project Management, Quality System Auditing and Validation, solution design and solution sales. Anthony has served in several capacities in the regulated space including Director of Quality and Quality Systems. His experience brings a well-rounded customer and vendor perspective to successful quality system implementation and validation. Anthony currently leads the team of US Principals supporting eQMS sales and implementation for IQVIA’s QMS pillar.
Davor Milosevic has extensive experience within the Quality Assurance function of the life sciences industry. Over the last 15 years, Davor has designed, implemented, and maintained various GxP, Quality Assurance (QA), and Quality Control (QC) programs, as well as compliance infrastructures, including documentation (SOP) systems and training programs, and has performed hundreds of internal and external audits. He has led and managed inspections by FDA, other regulatory agencies (AABB, AATB, ISO, etc.), and commercial partners. His ability to build trust and confidence in an organization’s quality management system has established his expertise in the Quality Assurance arena. Davor is currently the Quality Assurance Director of Safety, Regulatory, and Quality for IQVIA.
Connected, integrated, compliant. Build, scale, and optimize your quality and regulatory workflows with SmartSolve®, IQVIA's transformative Enterprise Quality Management System, built for Life Sciences.
Meet the challenge of changing stakeholder demands and increasing cost constraints with IQVIA's integrated technology services and analytics-driven offerings.
From manufacturing oversight to regulatory requirements, manage quality across your organization with a single enterprise software solution.
We're pleased to speak with you during our business hours.
For international calls please refer to our toll-free list.
Get in touch today to discover the right solutions for you.
We are pleased to speak with you during our standard business hours.
For international call please find a number in our toll-free list.
Please use this form to reach out to our media team with inquiries. Thank you.