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FDA Inspections - What Regulators Expect and How to Prepare

 
  January 06, 2016  
     
 
Center for Professional Innovation & Education, Inc., Malvern, PA
March 21 & 22, 2016


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, Inc. 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 10 years, Kerry has provided consulting, training and mentoring services to several pharmaceutical firms in the United States and Europe through regulatory remediation activities (e.g. Consent Decree, Warning Letters), training and training systems development, documentation control, and project management.

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

Mr. Potter received his B.S. in Chemistry from James Madison University. He has received qualifications and certifications in quality auditing, facilitation and training – including instructional design and competency-based curricula. His past and current affiliations include ASQ, ASTD, PDA, GMP-TEA, ASPI and AQP.

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