FDAnews Announces — China Medical Device Regulatory Changes Webinar, Jan. 31, 2017

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If manufacturers are doing business in China or want to, they need to know the latest device regulatory requirements for manufacturing devices there. During this webinar Grace Fu Palma, founder of China Med Device, will discuss recent developments in manufacturing regulations including new GMPs, self-inspections, foreign inspections and trends in enforcement.

China Medical Device Regulatory Changes
**An FDAnews Webinar**
Jan. 31, 2016 — 1:30 p.m. – 3:00 p.m. ET
http://www.fdanews.com/chinamdregulatorychanges        

If manufacturers are doing business in China or want to — they need to know the latest device regulatory requirements for manufacturing devices there.

Grace Fu Palma — founder of China Med Device — knows them. She has over 20 years of medical device industry experience in China and the United States, working with multi-national corporations and start-ups. Originally from Beijing, she capitalizes on a cross-cultural mindset gained from her experiences in both China and the U.S.

During this webinar Grace will discuss recent developments in manufacturing regulations including new GMPs, self-inspections, foreign inspections and trends in enforcement. These developments can affect all medical device companies, whether the manufacturing facilities are in China or abroad.

After this 90-minute webinar attendees will have a practical understanding of the following compliance issues:

  •     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.

Register today and be up-to-date on China’s medical device regulations.

Meet the Presenter:
Grace Fu Palma, Founder, China Med Device

Grace Fu Palma founded China Med Device in 2012 in Boston, Massachusetts. Since its founding, China Med Device has helped many U.S. medtech companies expand into China. Grace has over 20 years of medical device industry experience including driving product strategy, positioning, launches, sales channels development, partnership and JV establishment for both large multinationals and start-up companies. She is bilingual (English/Chinese) with a proven leadership ability to develop business alliances and grow sales in both emerging and mature markets.

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

Webinar Details:
China Medical Device Regulatory Changes
**An FDAnews Webinar**
Jan. 31, 2016 — 1:30 p.m. – 3:00 p.m. ET
http://www.fdanews.com/chinamdregulatorychanges

Tuition:
$287 per site

Easy Ways to Register:
Online:     http://www.fdanews.com/chinamdregulatorychanges                            
By phone: 888-838-5578 or 703-538-7600

About FDAnews:
FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations.

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Michelle Butler
FDANEWS
+1 (703) 538-7665
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