Dates: August 17-19, 2021 from 8:00 a.m. to 5:00 p.m.
About the CourseThis intensive course provides three days of engaging virtual training on design control requirements for FDA Quality System Regulation, ANSI/AAMI/ISO 13485:2016, and the Medical Device Single Audit Program (MDSAP). With the participation of FDA representatives during the entire course, attendees have the unique opportunity to participate in a shared learning experience.
Upon completing this course, participants will be equipped with the information to able to evaluate the degree of compliance of a design control system, including identification of noncompliance issues, and be prepared to implement the improvements needed to meet requirements.
This highly interactive course engages the learner with an in-depth discussion of industry best practices to learn how industry leaders address design control challenges. Exercises are designed to build a solid understanding of developing and applying design control requirements. Attendees will participate in structured discussions with their peers to develop solutions to solve current issues.
Examples of design control tools, templates, and practices, in use by medical device companies, stimulate discussion and provide a practical resource for future reference. Case studies and situation analyses are used throughout the program to help participants analyze potential areas of non-compliance, identify improvements, and evaluate the various methods of managing a design control program. Course content is the culmination of years of consensus development on the part of a respected group of quality system experts from leading device manufacturing companies, FDA, and industry consultants.
This material will appeal to quality professionals, managers, and FDA staff. Instruction is targeted to professionals involved in risk analysis and management. Given the broad application of risk analysis, this material will be of value to professionals working across the entire product lifecycle, including R&D, manufacturing, packaging, logistics, supplier quality, marketing, sales, product support, and regulatory affairs. It will also appeal to FDA staff interested in the application of best practices to support quality systems.
Meet your instructor:
Philippe Joly is the founder of e@syGMP, a training and consulting firm. He works mainly with European-based client firms to establish cGMP/QSR-compliant quality systems or to improve the efficiency of the existing ones. He has 15 years of experience in developing and delivering training on cGMP/QSR. Prior to this job, Philippe Joly has been involved in sales, marketing and product development for two international companies involved in the biopharmaceutical and medical device market. Philippe Joly has a MS degree in Biochemistry and Microbiology and a Master in Management and Marketing. He has lead several workshops and task forces (Personnel qualification, cleaning validation, validation of computerized systems, risk management) for the two main French Pharmaceutical societies.
Lindsey Howard, Jr. Vice President, Qiagen
With over 30 years of broad Quality and Regulatory experience, Lindsey’s career has spanned the drug, critical device, biologic, and In Vitro diagnostic industries. Currently, as QIAGEN’s Vice President and Head of Global Regulatory and Clinical Affairs, Lindsey is responsible for leading QIAGEN’s world-wide regulatory and clinical programs in molecular and companion diagnostics. Prior to this, he held various leadership positions at a number of other companies including, Digene, Wellstat Biologics, Life Technologies and Abbott. In addition to supporting AAMI, he is actively involved in AdvaMed and sponsors the FDA’s Experiential Learning Program at QIAGEN. He is also an ASQ Certified Quality Engineer and Certified Birkman® consultant.
Virtual Training Information
Our virtual training environment allows you to have direct interaction with your instructors and your fellow attendees. AAMI uses Zoom for virtual classes. You can test your connectivity and ability to use Zoom at zoom.us/test.
For virtual training courses, we request that you register at least one week in advance of the course start date to allow sufficient time for shipping of training materials and devices (Please allow two weeks for non-U.S. addresses). If you register within these time frames, AAMI cannot guarantee you will receive material prior to the start of the course but you will have access to digital versions of the materials. If you have any questions, please email firstname.lastname@example.org.