As we quickly approach the MDR enforcement deadline, medical device companies are transforming the way they manage regulatory information and operations to meet the new requirements. In this webinar, Veeva will host a fireside chat with Lori Holder, the director of regulatory affairs at Alcon, to discuss how her team is unifying regulatory operations to create a sustainable operating model for the future.
As a newly independent company, Alcon had the opportunity to select modern applications that support its ambitious research and development program. Attend the webcast to learn the focus of their implementation, why they chose a unified platform for submissions management and archiving, and their vision for the “new normal”.
Intermediate: Content is designed based upon the assumption that individuals have basic knowledge of the topic(s) and/or demonstrated competence related to the topic(s). Higher-level concepts are introduced during lectures; exercises requiring synthesis and/or application of concepts are incorporated into the activity.
Upon conclusion of the program, you will:
- Understand the impact of MDR throughout the total product lifecycle
- Grasp how a unified platform for submissions management and archiving maintains compliance and audit readiness
- Know how moving to a sustainable regulatory operating model can be beneficial for your organization.
Who Should Attend:
- Employees of medical device companies preparing management and operations to meet the new MDR requirements
- Employees of pharma, medical device and diagnostics companies that are interested in learning more about a unified RIM solution
- Regulatory professionals involved with compliance and audits
- Regulatory professionals managing global regulatory intelligence
Lori Holder, RAC, director of regulatory affairs operations at Alcon
Lori Holder is the director of global regulatory operations at Alcon Laboratories, Inc., a leading manufacturer of ophthalmic medical devices located in Fort Worth, Texas, heading the Regulatory Operations group. She has over 25 years of experience and has held positions of increasing responsibility in clinical research, quality assurance and regulatory affairs in the medical device industry, working for employers including Guidant Corporation, Sulzer Orthopedics, Sulzer Intermedics, and Cyberonics, Inc. She has held, and currently is the. Lori holds the Regulatory Affairs Certification (RAC) and earned a B.S. in Biomedical Engineering from Texas A&M University.
Terri Howard, RAC, director of strategy for medical devices and diagnostics at Veeva
Terri has more than 20 years of experience in life sciences, with the last decade focused on regulated content management technology for the medical device industry. She joined Veeva Systems in 2015 as director of strategy, with the goal of helping medical device companies leverage cloud technology to bring products to market faster and more efficiently. Throughout her career, Terri has worked with industry leadership teams to form and influence change in regulatory and marketing business practices, most recently at CareFusion, now BD.
Webcast registration includes access to handouts, presentation slides and the on-demand recording for one year.