Jay Chen is a Senior Vice President for the solution to FDA product tracing requirement (The Drug Supply Chain Security Act) at AceBIOS, Inc.
Acebios, Inc
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Senior Vice President For The Solution To Fda Product Tracing Requirement (Dscsa)Acebios, Inc 2017 - PresentPrinceton, NjAceBIOS, Inc is the exclusive distributor of Netorus, Inc. Netorus has over 15 years on innovation technology development and accomplished the whole flow eBPR(electronic Batch Production/Quality Records) for pharmaceutical industry. One of the innovations, the copyrighted technology “electronic monitoring code” was inspected by China FDA and has been enforced every drug and food manufacturer to utilize from 2007. The updated patented innovation cGMP QR eBPR/eBTR will be required by China FDA and the US FDA. AceBIOS locates at Carnegie Center, Princeton, NJ in 2011, and has positioned and partnered with many notable companies for their outsourcing business. The global pharmaceutical distributors have chosen the list of blockbuster generic drug products for AceBIOS contract manufacturing because Netorus eBPR cloud technology can guarantee ‘true records, best quality’. China government offer generous support. This position will allow AceBIOS to be at the forefront in the US Market as well in the Chinese Market.JC Chen welcomes all elites in the world to be friends and business partners, and share exciting life time together.The Drug Supply Chain Security Act (DSCSA) mandates that electronic serialization (eSerialization) be in place by November 2018 and unit level traceability by 2023. Netorus™ has the solution to FDA product tracing requirement. For the details, please see the following website:http://www.acebios.com/eSerialization/eSerialization.html
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Vice PresidentNetorus, Inc. 2002 - 2016Princeton, NjJC with Netorus team has achieved the following accomplishments:CSV(Computer System Validation)1st , The first innovator of the whole flow eBPR (electronic Batch Production/Quality Records) technology and corresponding the Computer System Validation Documentation in the world passed the US FDA inspection during Jan. 21 to Jan. 23, 2013.Patents2nd , NETORUS has over 2000 innovations. 3rd , 127 patent applications were submitted in China4th , 7 are already approved, 5th , 2 patents have been filed in the United States.Copyrights6th , NETORUS WEB-BASED GMP/ORP and GSP/ORP system V4.07th, NETORUS cGMP/GSP Quality Query V2.08th, Intelligent automation process control technology of SOP V1.09th, NETORUS PAT/MES V1.02013~, Netorus eBPR has been selected as the National Manufacturing Technology Model by China government in 2013. From 2009, all Chinese manufacturers who invested in Netorus Intelligent Manufacturing technology have been funded over RMB 100 Million by government of China.2012~2013, NETORUS V8.0 system and Computer System Validation was approved by the US FDA Jan23, 2013 at Conba Pharmaceutical.2010~2011, NETORUS V8.0 system was pre-approved by the FDA officers at pfizer Hisun Joint Venture Pharmaceutical. 2008~2009, NETORUS V7.0 system was developed at the Hisun Pharmaceutical and pre-approved by EU auditor. Whole-flow Computer System Validation was improved. 2006~2007, March 14, 2006, CSV was approved by SFDA at the Sine 2nd Factory of Shanghai Pharmaceutical GroupHisun Jiaojiang factory. Started Netorus V7.0 ORP/ MES.2004~2005, NETORUS V4.0 system was successfully implemented at the Yangtze River Pharmaceutical. Computer System validation were prepared based on V5.0. 2002~2003, Research and development of innovative technologies based on cGMP / ERP, and GAMP / MES.
Frequently Asked Questions about Jay Chen
What company does Jay Chen work for?
Jay Chen works for Acebios, Inc
What is Jay Chen's role at the current company?
Jay Chen's current role is Senior Vice President for the solution to FDA product tracing requirement (The Drug Supply Chain Security Act).
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