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US FDA 510(k): How to Put Together a Compelling 510(k): Good Practices with Increased Awareness

 
  October 21, 2013  
     
 
Global Compliance Trainings, online
2013-11-20


Dr.David Lim, Ph.D., RAC, ASQ-CQA. Dr. Lim is President and Principal of Regulatory Doctor (www.RegulatoryDoctor.com). Dr. Lim frequently presents global regulatory and quality compliance topics in various forums and meetings. Recently, Dr. Lim developed 510(k) templates ready for use compliant with e-Copy and RTA policy. In addition, Dr. Lim developed FDA inspection checklists for drug and medical device manufacturers based on his analysis of FDA inspectional observations cited in 483s for the past seven years. Dr. Lim provides his feedback to regulatory agency (e.g., US FDA) through public comments and also served as a panel member during the FDA’s transparency public meeting in 2009. Dr. Lim contributes to the Regulatory Affairs Professional Society (RAPS) as an author. Dr. Lim leads and directs all research projects including pharmacovigilance, medical device reporting, recalls and patient safety signals being conducted at the Regulatory Doctor
 
 
Organized by: Global Compliance Trainings
Invited Speakers: Dr. David Lim
 
Deadline for Abstracts: 2013-11-20
 
Registration: 2013-10-21
E-mail: globalcompliancetrainings1@gmail.com
 
   
 
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