Overview of-device-regulation-fda-san-diego-ca
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The document details a 2-day in-person seminar on FDA device regulation taking place on April 20-21, 2017, in San Diego, CA, led by Dr. Thomas E. Colonna. The seminar will cover various topics including regulatory strategies, 510(k) processes, and post-market surveillance, and is targeted at regulatory professionals in the medical device field. Registration is available with early bird discounts, and participants will receive materials and networking opportunities.
Overview of-device-regulation-fda-san-diego-ca
- 1. 2-day In-person Seminar: Knowledge, a Way Forward… Overview of Device Regulation - FDA San Diego, CA April 20th & 21st, 2017 8:30 AM to 5:30 PM Thomas E. Colonna Price: $1,295.00 (Seminar for One Delegate) Register now and save $200. (Early Bird) **Please note the registration will be closed 2 days (48 Hours) prior to the date of the seminar. Price Overview : Global CompliancePanel 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. 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. $6,475.00 Price: $3,885.00 You Save: $2,590.0 (40%)* Register for 5 attendees Founder, Biotech Consultant LLC
- 2. Global CompliancePanel Agenda: Day One Day Two 2-day In-person Seminar: Overview of Device Regulation - FDA Lecture 1: Overview of FDA Medical Device Regulation 9 am - 10.30 am Registration & Breakfast 8.30 am - 9.00 am Lecture 2: Overview of FDA Medical Device 510(k) Premarket Notification Process 11.00 am - 12.30pm Break 10.30am - 11.00 am Lecture 3: Overview of FDA Medical Device PreMarket Application Process 1.30 pm - 3.00 pm Lunch 12.30 pm - 1.30 pm Lecture 4: Overview of FDA Device Manufacturing Issues 3.30 pm - 5.00 pm Break 3.00 pm - 3.30 pm Lecture 5: Q & A 5.00 pm - 5.30 pm Lecture 1: Overview of In Vitro Diagnostic Regulation 9 am - 10.30 am Registration & Breakfast 8.30 am - 9.00 am Lecture 2: Overview of Biomedical Software Regulation 11.00 am - 12.30pm Break 10.30am - 11.00 am Lecture 3: Overview of FDA Medical Device Post-Market Surveillance 1.30 pm - 3.00 pm Lunch 12.30 pm - 1.30 pm Lecture 4: Overview of Device Regulatory Strategies 3.30 pm - 5.00 pm Break 3.00 pm - 3.30 pm Lecture 5: Q & A 5.00 pm - 5.30 pm 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. Who Will Benefit: Regulatory professionals working in the medical device field Areas Covered in the Session: Describe the elements impacting the definition and classification of medical devices Determine the points to consider in the development of a regulatory strategy Define the tools for regulatory strategy development Recognize sources of regulatory and competitive intelligence Identify the elements of a regulatory plan Apply regulatory principles to develop a regulatory plan
- 3. Global CompliancePanel www.globalcompliancepanel.com Kindly get in touch with us for any help or information. Look forward to meeting you at the seminar GlobalCompliancePanel What You will get Special price on future seminars by GlobalCompliancePanel. Networking with industry's top notch professionals 7 9 1 Learning Objectives 2 Participation certificates Interactive sessions with the US expert Post event email assistance to your queries. Special price on future purchase of web based trainings. Special price on future consulting or expertise services. 3 4 5 6 Seminar Kit – includes presentation handout, ID card, brochure, trainings catalog, notepad and pen. 8 Contact Information: Event Coordinator NetZealous LLC, DBA GlobalCompliancePanel 161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA Toll free: +1-800-447-9407 Fax: 302 288 6884 Email: support@globalcompliancepanel.com 10% 20% 25% 30% 2 Attendees to get offer 3 to 6 Attendees to get offer 7 to 10 Attendees to get offer 10+ Attendees to get offer Group Participation Payment Option 1 Credit Card: Use the Link to make Payment by Visa/Master/American Express card click on the register now link 2 Check: Kindly make the check payable to NetZealous DBA GlobalCompliancePanel and mailed to 161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA PO: Please drop an email to support@globalcompliancepanel.com or call the our toll free +1-800-447-9407 for the invoice and you may fax the PO to 302 288 6884 Wire Transfer: Please drop an email to support@globalcompliancepanel.com or call our toll free +1-800-447-9407 for the wire transfer information 3 4 2-day In-person Seminar: Overview of Device Regulation - FDA