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Automating quality management systems in academic research environments
December 3, 2024, 3pm EST
University laboratories are essential hubs for innovation, research and education. Each plays a crucial role in advancing knowledge and developing innovative solutions in the healthcare space, often leading to profitable collaborations with larger organizations to further its research and development efforts. However, maintaining high standards of quality, assurance and compliance presents unique challenges.
Join our regulatory expert with over 35 years' experience in healthcare product development across academia and industry, Joanne Rupprecht and life sciences consultant, Anthony Gruttadauria for an engaging webinar addressing these issues.
In this session, we will cover the importance of automating your quality management system under the recently published Quality Management System Regulation (QMSR). You will discover how software like Ideagen Quality Management can streamline processes, decrease risk and enhance training, ensuring that academic research environments meet the highest standards of quality assurance and regulatory compliance.
Our speakers will also discuss why Ideagen Quality Management is a practical and powerful software tool for document management, training, auditing and continuous improvement. Learn how to improve operational efficiency and reduce compliance risks with a system trusted by leading academic research institutions worldwide.
Who should attend? Laboratory managers, quality assurance and regulatory compliance professionals and academic leaders interested in safeguarding their research and developments operations.
Don't miss this opportunity to find out how technology and automation software can support academic research and ensure quality and regulatory compliance excellence.
Key takeaways:
- Find out about laboratories most pressing challenges when it comes to compliance.
- Discover how Ideagen Quality Management is supporting laboratories across the globe.
- Learn about practical software applications for operational excellence.
- Explore tools for document management, auditing and continuous improvement.
- Understand strategies to enhance efficiency and mitigate compliance risks.
Joanne Rupprecht is an experienced leader in quality and regulatory affairs, federal agency/life sciences law, and higher education.
Jo has more than 35 years of healthcare product development experience in both academia and industry and is proficient in matters of domestic (FDA) and international regulatory affairs and quality systems for medical devices, pharmaceuticals, and biologics including CAR T Cell and stem cell therapies, as well as vaccines.
Jo acquired much of her healthcare research and development experience at the University of Illinois, the University of Chicago, and Abbott Laboratories, before earning her Juris Doctor at the University of Denver Sturm College of Law.
Thereafter, Jo received her Life Sciences Compliance Certification from the Seton Hall University School of Law, her RAC in both U.S. and Global regulatory affairs, is a Certified Professional by the Association for Clinical Research Professionals (ACRP-CP), is a Certified Corporate Compliance and Ethics Professional (CCEP), and is accredited by the Association for College and University Educators (ACUE). She was also inducted as a Fellow into the Regulatory Affairs Professionals Society (FRAPS).
She enjoys developing and implementing quality and regulatory systems for domestic and international healthcare product commercialization, is a contributing author to the Regulatory Affairs Professionals (RAPS) U.S. Regulatory Affairs Writing manual, its Fundamentals of International Regulatory Affairs manual, and its Fundamentals of U.S. Regulatory Affairs manual, and taught Biomedical Entrepreneurship and The Regulatory Environment of Life Science Innovation at the University of Colorado, Denver on the Anschutz Medical Campus where she also served as a Board Member for the BESST (Broadening Experiences in Scientific and Scholarly Training) Program.
Jo has dedicated her career to bridging science, business, law and education in diverse industry and academic environments and enjoys working alongside entrepreneurs, innovators, and disruptors in the healthcare space to assist them with navigating complex quality and regulatory requirements and establishing compliant operations. She prides herself on anticipating and evaluating business risks, public policy, and governmental influences so as to positively impact business operations, protect companies and empower others with the information needed to succeed!
Anthony Gruttadauria supports healthcare and life sciences organizations to enhance compliance and streamline their quality processes with a focus on ISO, GxP, ICH and FDA regulations.
With a deep understanding of the industry and the challenges of regulated environments, he works side by side with quality leaders to create efficient and audit-ready operations.
His goal is to empower teams to improve product integrity and drive continuous improvement through quality programs.