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cGMPs for Medical Devices, Including In Vitro Diagnostic Devices

 
  June 05, 2012  
     
 
ComplianceOnline, Online Event
2012-06-26


Why Should You Attend:

To achieve sustainability and to remain sustainable and competitive in medical device markets, it is necessary to establish and follow good manufacturing practices (cGMPs) set out in the quality system regulations (QSRs), which help assure that medical devices are safe and effective for their intended use.

Understanding QSRs and the quality requirements can significantly contribute to achieving compliance fast, resulting in saving significant amount of time and efforts and bringing innovative medical products to the market faster.

This webinar will discuss QSRs, requirements and compliance. This session will familiarize participants with the current Good Manufacturing Practice (cGMP) for medical devices including in vitro diagnostic devices. At the end of the webinar, you will get empowered in a way that you would plan, develop, maintain and implement the relevant procedures efficiently and effectively.

Areas Covered in the Seminar:
  • QSRs for medical devices and in vitro diagnostic devices.
  • Definitions.
  • Flexibility of the QSRs.
  • Quality system (QS) requirements.
  • Management responsibility and personnel.
  • Audits.
  • Design control: design and development planning, design input, design output, design review, design verification, design validation, design transfer, and design changes.
  • Design history file (DHF).
  • Device master record (DMR).
  • Quality system procedures.
  • Purchasing controls.
  • Inspection, measuring and test equipment.
  • Process validation.
  • Corrective and preventive action (CAPA).
  • Complaint files.
  • Servicing.
  • Quality requirements for premarket approval (PMA) application.
  • Enforcement actions: case studies.
  • Lessons learned.
 
 
Organized by: ComplianceOnline
Invited Speakers: Dr. Lim, obtained his Ph.D. in biological sciences at the University of Missouri-Columbia and published his thesis research in the prestigious journal “Science.” Since then, Dr. Lim has held various positions at Duke, US National Laboratories, Intrexon Corporation, Terumo, US FDA/CDRH, and EraGen Biosciences, Inc., A Luminex Company. In 2009, Dr. Lim served as a panel member during the FDA’s Transparency Public Meeting. Prior to founding his own consulting firm (www.RegulatoryDoctor.com/davidlim), Dr. Lim was Senior Vice President of Scientific and Regulatory Affairs at Aquavit Pharmaceuticals, Inc. in New York, wherein Dr. Lim provided inspiring and actionable solutions for sustainable business operation
 
Deadline for Abstracts: 2012-06-26
 
Registration:

For Registration:

 http://www.complianceonline.com/ecommerce/control/trainingFocus/~product_id=702349?channel=hummolgen

E-mail: referral@complianceonline.com
 
   
 
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