home   genetic news   bioinformatics   biotechnology   literature   journals   ethics   positions   events   sitemap
 
  HUM-MOLGEN -> Events -> Courses and Workshops  
 

FDA Inspections: What Regulators Expect and How to Prepare

 
  June 27, 2014  
     
 
Center for Professional Innovation & Education, Inc., Malvern, PA
Oct. 6 & 7, 2014


This course is designed to provide participants with an understanding of the parameters, approaches, and concerns of FDA inspectors, and the tools for preparing, coping, and managing those inspections in pharmaceutical, biologics, and device facilities.

Additional benefits of this class include discussion of:

  • FDA authority and process including 483s, Warning Letters, recalls, and other potential actions
  • The FDA inspection process and approach
  • Device Master Records requirements
  • The use of a mock audit and outside certifying audit
  • Required documentation, format, and archive
  • How to respond to inspection and audit results
  • Parallel process from the EMEA, TGA, PMDA, and other international regulatory agencies
  • A chance to actively learn form fellow participants and well as from an instructor who brings 30 years of practical regulatory experience to a lively combination of lecture, discussion, and exercises

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:

Mr. Kerry Potter is the founder of Summit Consulting. He has more than 30 years of experience in project management, regulatory compliance systems, quality assurance, quality systems audits, regulatory training, employee development, GMP and documentation.

During the past five years, Kerry has offered consulting and mentoring services to several companies through remediation activities, training and project management. In this time, he has assisted pharmaceutical firms worldwide in remediation and project management in quality systems, manufacturing controls and training functions for the past five years.

Mr. Potter gained his pharmaceutical-manufacturing experience during a 28-year career with Merck. His experience has spanned quality operations, audits/inspections, laboratory services, human resources and learning/development. His responsibilities included quality inspector, analytical chemist, quality motivation administrator, laboratory quality-management assessment, GMP lead auditor, FDA quality-management system manager, 5S coordinator, GMP trainer, OSHA regulations, process safety management training and public relations.

Mr. Potter received his B.S. in Chemistry from James Madison University. He has also received qualifications and certifications in facilitation and training – including instructional design and competency-based curricula.

Mr. Potter is currently ASQ Certified as a Quality Auditor. His past affiliations have included ASQ, ASTD, PDA, GMP-TEA, ASPI and AQP.

 
Deadline for Abstracts: n/a
 
Registration: CLICK HERE TO REGISTER
E-mail: info@cfpie.com
 
   
 
home   genetic news   bioinformatics   biotechnology   literature   journals   ethics   positions   events   sitemap
 
 
 

Generated by meetings and positions 5.0 by Kai Garlipp
WWW: Kai Garlipp, Frank S. Zollmann.
7.0 © 1995- HUM-MOLGEN. All rights reserved. Liability, Copyright and Imprint.