Overview of Device Regulation FDA 2017
- Start Date:
- Thursday, 20 April, 2017
- End Date:
- Friday, 21 April, 2017 5:30pm
- Pain Management, Endocrinology, Infectious Disease, Internal Medicine, Emergency Medicine, Pulmonary Medicine, Headache / Migraine, Business Practice
Overview:This course provides a basic description of an FDA regulatory strategy for medical devices and explains the relationships between regulatory strategy and product development. It offers guidelines for developing successful strategies for medical devices, including definitions and classifications, elements of regulatory strategy, sources of regulatory intelligence, selection of development and product clearance/approval pathways.Why should you attend :This course provides a basic description of an FDA regulatory strategy for medical devices and explains the relationships between regulatory strategy and product development.
It offers guidelines for developing successful strategies for medical devices, including definitions and classifications, elements of regulatory strategy, sources of regulatory intelligence, selection of development and product clearance/approval pathways.Areas Covered in the Session:Describe the elements impacting the definition and classification of medical devicesDetermine the points to consider in the development of a regulatory strategyDefine the tools for regulatory strategy developmentRecognize sources of regulatory and competitive intelligenceIdentify the elements of a regulatory planApply regulatory principles to develop a regulatory plan Who will benefit:Regulatory professionals working in the medical device field Agenda:Day 1 Schedule Registration & Breakfast8.30 am - 9.00 amLecture 1:Overview of FDA Medical Device Regulation9 am - 10.30 am Break10.30am - 11.00 amLecture 2:Overview of FDA Medical Device 510(k) Premarket Notification Process11.00 am - 12.30 pm Lunch12.30 pm - 1.30 pmLecture 3:Overview of FDA Medical Device PreMarket Application Process1.30 pm - 3.00 pm Break3.00 pm - 3.30 pmLecture 4:Overview of FDA Device Manufacturing Issues3.30 pm - 5.00 pmLecture 5:Q & A5.00 pm - 5.30 pm Day 2 Schedule Registration & Breakfast8.30 am - 9.00 amLecture 1:Overview of In Vitro Diagnostic Regulation9 am - 10.30 am Break10.30am - 11.00 amLecture 2:Overview of Biomedical Software Regulation11.00 am - 12.30 pm Lunch12.30 pm - 1.30 pmLecture 3:Overview of FDA Medical Device Post-Market Surveillance1.30 pm - 3.00 pm Break3.00 pm - 3.30 pmLecture 4:Overview of Device Regulatory Strategies3.30 pm - 5.00 pmLecture 5:Q & A5.00 pm - 5.30 pm Speaker:Thomas E.
Colonna,Founder, Biotech Consultant LLC Dr. Thomas E. Colonna earned a bachelor of science in microbiology from the University of Sciences in Philadelphia (formerly the Philadelphia College of Pharmacy and Science), a Ph.D. in molecular biology from the Johns Hopkins University, and a law degree from the Georgetown University Law Center. In addition to his consulting activities, Dr. Colonna is the Director of the MS in Regulatory Science and MS in Food Safety Regulation programs at Johns Hopkins University.Dr.
Colonna provides consulting services in the scientific and regulatory aspects of a wide range of medical devices and biologics with particular expertise in the areas of in vitro diagnostics (ELISA-based, PCR-based, SNPs, microarrays, and pharmacogenomics), medical device software (including bioinformatics), and biotechnology-based products. Dr. Colonna?s consulting clients range from Fortune 500 companies to small start-up companies located throughout the US, as well as, Canada, India, and Russia.
Widely published in numerous fields, Dr. Colonna brings a unique multidisciplinary approach to problem solving. Location: San Diego, CA Date: April 20th & 21st, 2017 and Time: 8:30 AM to 5:30 PM Venue: Four Points By Sheraton San Diego DowntownAddress: 1617 1st Avenue - San Diego, California, 92101 - United States Price: Register now and save $200. (Early Bird) Price: $1,295.00 (Seminar Fee for One Delegate) Until March 15, Early Bird Price: $1,295.00 from March 16 to April 18, Regular Price: $1,495.00 Register for 5 attendees Price: $3,885.00 $6,475.00 You Save: $2,590.00 (40%)* Quick Contact:NetZealous DBA as GlobalCompliancePanel Phone: 1-800-447-9407Fax: 302-288-6884Email: email@example.com Follow us on LinkedIn: https://www.linkedin.com/company/globalcompliancepanel?Like us our Facebook page: https://www.facebook.com/TrainingsAtGlobalCompliancePanel/Follow us on Twitter: https://twitter.com/GCPanel
Four Points By Sheraton San Diego Downtown 1617 1st Avenue San Diego,
92101 United States
Conference organized by NetZealous DBA as GlobalCompliancePanel
- NetZealous LLC-globalcompliancepanel, 161 Mission Falls Lane, Suite 216, Fremont,CA94539, USA
- Event Manager