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Effective Document Management for the Pharmaceutical, Biotech & Medical Device Industries

 
  July 10, 2015  
     
 
Center for Professional Innovation & Education, Inc., Los Angeles, CA
August 24 & 25, 2015


If you didn’t write it down, it didn’t happen! This is the position of the FDA and most regulatory agencies internationally. Good documentation is vital for doing business in the regulated world from discovery through marketplace. It is also important for due diligence and regulatory inspections, and is necessary for the success of your products and services. While the regulations tell you what you must do, they don’t tell you how. Based on industry best practices, this course clarifies how to refine your existing system, create a new one, or prepare to transition from a manual system to electronic controls.

This course also addresses what documents you need to control, what documentation you need to support your actual system and how to keep your documents current and compliant.

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:

Kay Monroe

Specialties: Quality, Management

Kay Monroe is Acting Executive Director of Zagaya. This non-profit – specializing in Malaria – works to bring innovative technologies to the problems of global health in the developing world.

Ms. Monroe has spent over 25 years with biotechnology and pharmaceutical companies around the world; working on global project teams from Research through Phase IV and introducing Project Management Offices into several companies. She has extensive experience in product lifecycles and the creation of submission documents. In addition, she has sourced both items and processes for pharmaceuticals, biologics and devices.

Ms. Monroe has held positions as Vice President of Operations, Project Management and Quality Assurance in companies such as Lundbeck, Synarc and Genentech. She has extensive experience in the start-up environment with such companies as Cerus, Dynavax and Amyris.

Ms. Monroe received her Bachelors of Science in Animal Science from UC Davis and her MBA from Golden Gate University.

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