With international trade and trade relations becoming a hot topic in the news as a new president takes his seat in the White House, those manufacturers who currently do business in China and those who want to may have questions and concerns about the latest regulatory requirements for manufacturing medical devices there.
Those questions and concerns will be addressed by an expert in the field during an FDAnews Webinar on January 31, 2017, from 1:30 p.m. to 3:00 ET. Our CEO, Grace Fu Palma, who has over 20 years of medical device industry experience between China and the United States, will be speaking on these regulatory changes during the webinar. In addition to extensive industry experience, including driving product strategy, positioning, launches, sales channel development, partnership, and JV establishment, Grace, originally from Beijing, has unique insight into China-U.S. business relationships, having worked with large multinational corporations and start-ups in both countries.
In this webinar, Grace will discuss recent developments in manufacturing regulations that apply to manufacturers in China and abroad. She will address Good Manufacturing Practices (GMPs), self-inspections, foreign inspections, and trends in enforcement, providing attendees with a practical understanding of compliance issues relating to:
- Implementation of the new GMPs, including the procedural rules for inspections, preparation, communicating with investigators, 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.
The opportunity to learn about medical device regulatory changes from an insider with vast experience and knowledge specific to the field is a must for any business professional, consultant, or service provider who is involved in the engineering, management, R&D, compliance, manufacturing, strategic planning, and quality control of medical devices.
For more information about, or to register for this webinar on China Medical Device Regulatory Changes, please visit http://www.fdanews.com/chinamdregulatorychanges, or call 888-838-5578 or 703-538-7600.