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Quality Risk Management Overview for Pharma and Biopharma, ICH Q9/ISO 14971

 
  September 12, 2012  
     
 
ComplianceOnline, Online Event
2012-11-09


Why Should You Attend:

In this 90-minute webinar we will define risk and what constitutes risks primarily per ICH Q9 and reference ISO 14971 where applicable. The presenter will discuss principles and examples of tools for quality risk management that can be applied to different aspects of pharmaceutical quality.

The overall goal of this course is to raise awareness for Quality Risk Management to improve patient safety and also to prepare organizations for regulatory inspections. The session provides quality assurance professionals with a management perspective to make the right decisions for their organization to balance cost vs. risk.

This training provides participants with the knowledge, tools and confidence to understand and participate in a risk management program in a pharma and biopharma industry and an understanding of the significance of effective communication.

Areas Covered in the Seminar:

Quality Risk Management Overview

  • Understanding Risk
  • Application of ICH Q9
  • Definitions and Concepts
  • Risk Assessment
  • Risk Control
  • Risk Communication
  • Risk Review
  • Example of Risk Management Methods and Tools

Event Details:
 
Date:                     November 09, 2012
Time:                    10:00 AM-11:30 AM PDT
Cost:                     $249 per attendee per computer terminal
Registration:        SIgn-Up on-line now.  Add to your shopping cart.

 

 
 
Organized by: ComplianceOnline
Invited Speakers: Tanvir Mahmud, has more than 14 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 Masters Degree in Physical and Biochemistry and a Master Certification in coaching. 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. 
 
Deadline for Abstracts: 2012-11-09
 
Registration: http://www.complianceonline.com/ecommerce/control/trainingFocus/~product_id=702422?channel=hummolgen
E-mail: referral@complianceonline.com
 
   
 
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