Falls Church, VA (PRWEB) August 09, 2016
http://www.fdanews.com/mdinspectionschina. Devicemakers need to be up to speed on the latest device inspection requirements for manufacturing in China. And, importing them into the country.
John Balzano, a leading authority on China medical device regulation, will provide an analytical introduction to China’s medical device regulations including GMPS, self-inspections, foreign inspections and enforcement trends and requirements for importing devices.
In 90 minutes, attendees will gain a practical understanding of the following compliance issues:
- Implementation of new GMPs, including the procedural rules for inspections, preparation, communicating with inspectors, resolving issues, and potential penalties.
- Transfer of manufacturing sites and amendment of manufacturing and device licenses.
- Policies and rules on contract manufacturing for medical devices.
- Handling self-inspections and evaluations of past compliance, including recent examples.
- Issues in importation, testing and new trends in e-commerce.
Register today to gain a comprehensive understanding of the regulations that will affect operations in China.
Meet the Presenter:
John Balzano, Special Counsel, Covington and Burling, LLP
John Balanzo practices in the firm’s New York office in the food and drug group. Mr. Balzano represents companies and industry associations on U.S. and China regulatory and policy matters in the drug, biologic, medical device (including in vitro diagnostics), cosmetic and food spaces. He assists companies with compliance with the regulations of the China Food and Drug Administration (CFDA) and the National Health and Family Planning Commission (NHFPC), and advises on how to develop strategies for bringing their products to market in China.
Who Will Benefit:
- Consultants/service providers
- Engineering and design controls teams
- Compliance officers
- Executive management
- Manufacturing directors and supervisors
- Personnel new to the industry
- QA/QC personnel
- R&D staff
- Regulatory/legislative affairs professionals
- Risk management specialists
- Strategic planning and business development staff
- Attorneys/legal department
Medical Device Inspections in China
Aug. 30, 2016 — 1:30 p.m. – 3:00 p.m. ET
$287 per site
Easy Ways to Register:
By phone: 888-838-5578 or 703-538-7600
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