Description:

Join us for an insightful seminar on Quality Systems for Regulatory Compliance, hosted in partnership between the Querrey InQbation Lab and Northwestern’s Master of Science in Regulatory Compliance (MSRC) program.

If you're a startup founder navigating the complex regulatory landscape, this seminar is tailored for you. Presented by the Querrey InQbation Lab and Northwestern’s Master of Science in Regulatory Compliance (MSRC) program, this event will provide you with essential tools to understand how quality systems influence regulatory compliance for your business.

You’ll gain a solid understanding of key regulations such as FDA, DHHS, ISO 9000:2001, and GxP standards—frameworks that ensure your products meet safety and quality requirements, while simplifying your path to market approval. For instance, ISO 13485 establishes the global standard for quality management systems in medical devices, and GxP guidelines (including GMP and GCP) help protect against costly product failures and regulatory penalties. For startup founders, adhering to these standards early on can streamline regulatory approvals, minimize costly mistakes, and position your product for success in a highly regulated market.

Grasping these standards is essential for reducing risk, building credibility with investors and regulators, and ensuring your product’s success. This seminar offers valuable insights into industry best practices and evolving regulations, helping you stay competitive in a fast-paced market.

Don’t miss the opportunity to refine your compliance strategy and connect with experts who truly understand the challenges faced by early-stage companies.

About the Speakers…

Carol Beirne

Faculty Director, Master's in Regulatory Compliance, Northwestern University Caroll Beirne has over 27 years of experience at Abbott Laboratories in various quality leadership roles, most recently as a senior manager in the Corporate Quality organization. She has worked in both the pharmaceutical and medical device product areas. Beirne designed the management review procedure for the Diagnostics Division and represented the process and data to both internal and external auditors, including ISO and FDA. She has been extensively involved in process improvements throughout her career. She led a quality training staff in the Global Pharmaceutical Research and Development organization with German and US employees. She has served in multiple roles in CAPA investigations.

Nick McWilliam

Senior Clinical Project Manager, IQVIA and Adjunct Lecturer, Master's in Regulatory Compliance, Northwestern University Nick McWilliams has been in the pharmaceutical research industry since 2005. He has held roles within data management, clinical operations, and project management. His current position is Senior Clinical Project Manager at IQVIA Biotech, working on oncology studies with emerging biotech and non-profit industry sponsors. He graduated from the MSRC program in 2015 and is excited to bring his experience back to Northwestern to share with students.