Washington, DC, September 09, 2015 --(PR.com
)-- The course has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.
Seminar One Registration $999 Regular Price $1499
12-13 November Houston, Texas
It is imperative that medical device firms quickly recognize evolving regulatory requirements in the US and European Union (EU). In particular, it is important to adequately understand both 510(k) and CE mark processes so that the review process can be facilitated in a proactive, effective, and streamlined manner.
This seminar will discuss both US FDA 510(k) submissions and European conformity assessment applications for CE mark. The speaker will walk you through how to format a succinct and comprehensive 510(k) including technical documentation for CE mark purposes while addressing all applicable, regulatory and essential requirements.
This seminar will provide great opportunities to learn how to put together technical documentation for both 510(k)s and CE mark.
Who Will Benefit
This seminar will be valuable for anyone in the FDA-regulated industry including, but not limited to, medical device, drugs, biologics, in vitro diagnostic devices, combination products or companion diagnostics.
• Regulatory affairs (associates, specialists, managers, and directors)
• Clinical affairs (associates, specialists, coordinators, managers, directors and VPs)
• Quality assurance, quality control, and quality systems (associates, specialists, engineers, managers, directors and VPs)
• Research and development (associates, scientists, managers, directors and VPs)
• Product and development (associates, scientists, managers, directors and VPs)
• Marketing (associates, specialists, managers, directors and VPs)
• Contract manufacturing organization (associates, scientists, managers, directors and VPs)
• Contract research organization (associates, scientists, managers, directors and VPs)
• Senior and executive management (VPs, SVPs, Presidents, and CEOs)
• Contractors and subcontractors
• Compliance professionals
• Legal counsel
About Speaker Dr. David Lim is President and Principal of Regulatory Doctor providing global and FDA consulting services in various areas of regulatory affairs, quality, clinical affairs and regulatory compliance matters. As a leading industry speaker, Dr. Lim frequently presents global regulatory and quality compliance topics in various forums and meetings. Recently, Dr. Lim developed 510(k) and PMA/HDE templates ready for use compliant with e-Copy and RTA policy. In addition, Dr. Lim currently serves as a member of the Advisory Board for Inspection Insider published by FDA News.
World Compliance Seminars provides innovative Continuous Professional Education and e-learning solutions and Consulting. Our clients range from SME's to Fortune 500 companies. Our training services set new benchmarks, as a result of which our customers get custom cost-effective, on-demand training solutions from us.