Thursday, July 9, 2020 | 12:00 pm – 1:10 pm ET
China has been increasing its surveillance on post market monitoring with more regulations and random inspections both inside China and outside of China. Find out how to meet the upcoming deadline for the new Period Risk Evaluation Report (PRER) regulations now required by National Medical Products Administration (NMPA) for all Class II and Class III devices in their 1st approval cycle. Do not miss the PRER submission deadline of September 30, 2020.
In these webinar, we will give you a brief idea about:
- What is the latest requirements/regulations for PMS/QMS in China NMPA and US FDA
- How to complete and meet the China NMPA PRER submission deadline of September 30 2020
- Familiarize yourself with how to leverage your overseas QMS for your China operations by understanding China GMP regulations and Chinese culture differences
- Find out how to comply with required adverse events (AE) and serious adverse events (SAE) reports in FDA and NMPA
- Case Studies about mock audit, AE/SAE reporting, etc.
Grace Fu Palma
CEO, China Med Device, LLC
Grace brings 20+ years of industry experience to the medical device industry. She is the CEO of China Med Device (www.ChinaMedDevice.com) with offices in Beijing and Boston providing turnkey solutions for western medical device/IVD/CDx/combination products companies to enter China with NMPA (CFDA) regulation and CRO services. The company has processed 1,000+ CFDA certificates, 250+ Chinese and western companies’ success. A seasoned bilingual and bicultural MedTech executive, she held a variety of marketing, operational and strategic development management positions at both large multinationals (Hewlett Packard Medical) and startup companies (Teratech). She specializes in China NMPA (CFDA) regulatory (RA/QA/CRO/CER) and commercialization services. In addition, she founded Chinese American Heart Association (500+ cardiovascular clinical professionals) in 2005. Regulator speaker at key national and local MedTech meetings, a frequent contribute writer to multiple journals, FDA News, RAPS Forum, Medtech News etc. She grew up in Beijing, China and received a BA degree from Peking University, China, and an MBA from Yale University in New Haven, CT.
Director of Quality Assurance, China Med Device, LLC
Jason Liang is the Quality Assurance Director of China Med Device. He has 15+ years of QA/RA experience in medical device/IVD. He has held QA and RA management positions in several international corporations including Philips, Intertek, and TÜV Rheinland.
Jason is veteran auditor of medical device/IVD QMS for both international and domestic manufacturers in China. He is an expert on ISO 13485, QSR 820, China cGMP and understands the QMS dynamics between China, US, and EU. He has performed audits on a wide range of manufacturers in medical devices and IVDs (active, non-active), such as GE, Shimadzu, Fukuda, Panasonic, and many China domestic manufacturers.
Jason is a seasoned QMS trainer. His major training experience includes:
- ISO 13485 QMS training;
- European IVD Directive 98/79/EC, medical device Directive 93/42/EEC, and Directive 2007/47/EC training;
- Application of ISO 14971 risk management, including assessment of essential performance for IEC 60601-1 3rd edition;
- Application of IEC 62366 medical device usability; and China cGMP training.
Associate Director, Quality Assurance
With experience since 2002 in medical device Quality Assurance, Mr. Dan Goldstein is an Associate Director of Quality Assurance at MCRA. His primary focus is on quality system requirements for bringing new devices to market and on keeping experienced manufacturers in compliance with FDA and Notified Bodies. Mr. Goldstein provides MCRA clients with gap assessments, mock FDA inspections, Form 483 remediations, manufacturing transfers, Design History Files, Technical Documentation, and MDD-to-MDR updates.
Mr. Goldstein received his Bachelor of Arts from University of Maryland University College. He is certified by the American Society of Quality (ASQ) as a Certified Quality Auditor (CQA), and by Exemplar Global (RABQSA) as an ISO 13485:2016 Lead Auditor and an EU MDR Auditor.
Prior to joining MCRA in August 2016, Mr. Goldstein worked in Quality Assurance for various medical device manufacturers, with specialties including autologous blood products for wound healing and computer-aided-detection software for lung diseases. Mr. Goldstein updated, streamlined, and maintained quality systems for compliance with ISO standards and with regulations for FDA, EU, Canada, and Australia. He hosted FDA inspections and Notified Body audits, produced annual PMA reports to FDA, and created MDD-compliant Technical Files and FDA-compliant Device Master Records. He collaborated with hardware and software engineers, research scientists, and manufacturing staff to create component specifications, and led numerous training sessions on regulations and standards. Mr. Goldstein planned and directed validations of hardware design, software design, and manufacturing processes to build fully compliant Design History Files.