In Life Sciences, there are successes and potential pitfalls of adopting tried and tested methodology, including achieving RA/QA compliance and institutional transformation.
In this webinar, Stellar Regulatory Affairs Executive Director, Yvonne Middlefell, will provide an overview and candid insights and will illustrate real-life examples with a focus on product development and verification and validation using case studies and anecdotal hands-on experience gained across a range of medical device companies from multinationals to start-ups.
Along with the benefits of implementing robust QA management systems processes, procedures and documentation, the ultimate goal is to implement an operation that avoids burdensome and redundant practices, and one that ensures robust systems for fast routes to regulatory clearance or approval -- whenever possible.
About the Presenter
Yvonne Middlefell is the Executive Director at Stellar Regulatory Consulting Ltd, providing global RA consulting, training, and education for the IVD and Medical Device Sector. Yvonne holds a 2:1 Hons degree in Science, Technology, and Management from the Open University and is a fellow of RAPS. With RA certification in the US, Yvonne has more than 29 years of Global RA experience, having held positions as an Executive Director of Global QA/ RA and Director Global RA. She gained extensive knowledge during a 10-year period when she worked in the USA. With a subsequent year spent in Paris, France, she has worked for several key multinational corporations. These include Amersham Nycomed, Eastman Kodak, Bausch & Lomb, and Johnson & Johnson. She has held board positions and has set up QA/ RA functions for start-up companies. Her RA experience covers a broad sector. Yvonne has written and filed multiple 510(k)’s for a range of products that include immunoassays, clinical chemistry analyzers, infectious disease products, contact lenses, and solutions. She has written and filed a PMA and led RA activities for mergers and acquisitions.