Achieving best-in-class compliance in the medical device industry requires not only leveraging quality management tools, but also implementing sound process and documentation techniques. Whether your company is optimizing existing initiatives or anticipating a move from paper to electronic systems, you will come away from this half- day seminar with current and practical information to apply to your compliance initiatives. Join compliance expert Nancy Singer, a former Department of Justice litigator for the FDA, to gain industry insight and learn how to incorporate documentation best practices into your quality management program. The seminar will empower your organization to address concerns beyond those of implementation, providing tools to help you develop or update a quality management roadmap and drive additional value for your organization.
Participants will leave this session with:
- A current view of medical device industry trends in compliance
- Hands-on techniques for documenting CAPAs to demonstrate compliance
- Tools to support building a quality management roadmap that will help your business achieve best-in-class compliance
The program also provides the opportunity to network with peers throughout the day.
Click here to view the detailed agenda and to register
Presenters:
Nancy Singer, President, Compliance-Alliance
Tim Mohn, Industry Principal, Sparta Systems
Time: 7:30 am – 1:30 pm,
including continental breakfast and buffet lunch
Location: The Westin; Edina, MN
Click here for directions
Who Should Attend: Medical device industry professionals that interact with quality management systems.
Nancy Singer founded Compliance-Alliance LLC to specialize in the professional development for those employed in the drug and medical device industries. Her career began as an attorney with the United States Department of Justice where she did litigation for the Food and Drug Administration. Subsequently she was a partner at the law firm of Kleinfeld Kaplan and Becker.
She then served as AdvaMed’s Special Counsel for FDA compliance and enforcement matters. In her role as Special Counsel, Nancy was a member of the FDA/industry working group that evaluated and suggested reforms to the FDA inspectional process. She then represented the industry on the working group that conceived and validated the procedures for the Quality System Inspection Technique (QSIT). She served as the industry spokesperson on the educational programs that taught QSIT to representatives of FDA and the medical device industry. While working on QSIT and the FDA/Industry Grass-Roots Task Force, Nancy received Vice President Gore’s Reinventing Government Hammer Award. She received the FDA Commissioner’s Special Citation on two occasions. Nancy was awarded a B.S. from Cornell University , and J.D. and LL.M. degrees from New York University Law School. During her career, she taught food and drug law at Catholic University Law School and George Washington University Law School. She chaired the Food and Drug Law Section of the Federal Bar Association, and retired as a Commander in the United States Naval Reserve.
Tim Mohn is an Industry Principal in Sparta Systems’ Product Management group. In this role, Tim is responsible for monitoring changes in the regulatory environment and trends in the life sciences industry.
Tim previously served as Worldwide Quality Systems Manager at Ortho-Clinical Diagnostics, a division of Johnson & Johnson. At OCD he was part of the TrackWise team for 7 years, and he championed eMDR and SAP integration activities. In addition Tim was the CAPA process owner, and he directly supported multiple FDA inspections at OCD's different locations. Prior to J&J Tim worked at Pfizer Consumer Healthcare and Wyeth Pharmaceuticals. Tim has a BS in Biology and a Masters in Manufacturing Management from Penn State.
