Thursday, 13 September 2018
7:30-11:00 am CDT
Ewald Conference Center
1000 Westgate Drive
St. Paul. MN 55114
+1 652 203 7243
Major changes to the EU MDR require major changes for manufacturers, including product portfolios and internal management system processes. This requires collaboration and coordination of efforts across multiple departments, each with their own requirements, perspectives and points of view, with regulatory professionals in the middle trying to manage needs, wants and regulations.
Leveraging effective project management techniques can help mitigate the inevitable conflicts arising from these situations and keep the transition project on course. The first presentation of this this event will provide best practices and insights into effective project planning and project management, a skill that regulatory professionals need to have on their resume. Topics to be covered include:
- The top 10 most common mistakes a project manager makes
- Project Charters – your savior
- Communications - what you need to know and practice
- The minimum information needed for planning and why you need them
- Interviewing techniques for gathering project data points
MDR document and data organization is critical to creating and implementing an efficient EU MDR portfolio planning process and transition plan. MDR portfolio planning begins with the process of combining technical documents and data with regulatory requirements into a manageable database. The inputs include identification of design dossiers and technical files and the FG part numbers on the corresponding DOC’s, EC certification expiration dates, planned product lifecycle management obsolescence dates, and preliminary assessment of remediation needs.
All of these inputs are used to realign and reduce regulatory files, schedule remediation and file transition activities and propose portfolio plan revisions that benefit the company – considering the significant cost and resources needed to transition products to the EU MDR. The second presentation will provide real-world examples of using this process, share efficiencies gained from it and demonstrate the effective communication and alignment that can be achieved as a result.
This event is brought to you by the RAPS Twin Cities chapter and is intended to facilitate professional development and networking opportunities for regulatory professionals in your region. Breakfast will be provided for all attendees and RAC holders may claim three RAC recertification credits.
Featured speakers:
Julie Maes, director, territory operations, Regulatory and Quality Solutions LLC
Joe Perzel, president, JPerzel & Associates
Registration Information:
RAPS Members: $50
Nonmembers: $65