22 March 2018
11:00am – 12:30pm ET
Sponsored by: MasterControl
Many medical device manufacturers are preparing for their initial Medical Device Single Audit Program (MDSAP) audit conducted by an Auditing Organization (AO) against the requirements of the MDSAP model and, potentially, multiple jurisdiction requirements. Quality assurance and regulatory affairs representatives are concerned about being adequately prepared for a successful outcome, as Health Canada’s deadline of January 2019 is fast approaching. The lack of adequate preparation and focus could lead to unnecessary nonconformities being detected with consequent certification delays and risks to market access.
This webcast features four leading experts: an ex-regulator responsible for leading the design of MDSAP; a manufacturer that has already successfully completed multiple MDSAP audits; and AOs that are actively auditing MDSAP compliance. Learn top-tips for preparing and eliminating risk from your plans. Engage in a Q&A session to help refine your preparations for first-time MDSAP success.
Learning Levels:
Basic: Content is introductory in nature and requires no requisite knowledge or experience to grasp concepts and related exercises. Basic educational activities are meant to establish a foundation of knowledge and/or competence that will be expanded upon in practice or in higher level activities.
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.
Learning Objectives
Upon the webcast's conclusion, you will be able to:
- Confidently prepare for audits under MDSAP
- Access other sources of detailed MDSAP information
- Identify key gaps in your MDSAP preparations
Who Should Attend
- Regulatory, compliance and quality staff involved in preparing for and hosting MDSAP audits
Speakers
Kim Trautman, executive vice president, NSF
Connie Hoy, executive vice president, Hologic
Patricia Murphy, global head of MDSAP programs, BSI Healthcare
Brian Ludovico, executive director, NSF Health Sciences