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Integration of Risk Management Principles and Activities into the Quality System

 
  July 10, 2015  
     
 
Center for Professional Innovation & Education, Inc., Malvern, PA
August 10 & 11, 2015


Risk management is a practice with processes, methods, and tools for managing risks in a project.  It provides a disciplined environment for proactive decision making to continuously assess what could go wrong within an organization and with its products.  This course will cover which risks are important to deal with and how the implementation of strategies can reduce and mitigate risks. 

Topics cover current US and international regulatory requirements with respect to development and implementation of effective risk management program.  A focus will be placed on ICH Q9 and an overview of ISO 14971.

The QMS elements to be covered are Corrective and Preventive Action, Supplier Management, Change Control, Complaints, Management Reviews and Audits.

This course will also provide participants with a systematic approach for identifying potential failure modes and analyzing effects for product design and manufacturing processes.

This course has been pre-approved by the Regulatory Affairs Professionals Society (RAPS) as eligible for 12 credits towards a participant's RAC recertification upon full completion.

 
 
Organized by: Center for Professional Innovation & Education
Invited Speakers:

Tanvir Mahmud has more than 17 years’ experience in product development, quality and project management in regulated industries including Biogen Idec, Vertex Pharmaceuticals, Boston Scientific and Consulting Companies.  She has a Master’s Degree in Physical and Biochemistry and a Master Certification in coaching.  ASQ Certificate Of Achievement For Presentation of Quality Risk Management at the NEQC 59th & 60 th Conference 2012 and 2014.

Her professional experience relates to research and development, analytical development, formulation development, quality management, chemistry manufacturing and control, drug/device/biologics/combination product stability, training, leadership development and program management.

Tanvir designs, develops and delivers training in Quality Risk Management and other customized training for Pharma, Biopharma and Medical Device Industries.  Tanvir is a member of the Regulatory Affairs Professional Society, Project Management Institute and a Toastmaster International Club.

 
Deadline for Abstracts: n/a
 
Registration: CLICK HERE TO REGISTER
E-mail: info@cfpie.com
 
   
 
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