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Good Laboratory Practices (GLP) for Pre-Clinical Testing

 
  July 14, 2014  
     
 
Center for Professional Innovation & Education, Inc., Malvern, PA
Dec. 8 – 10, 2014


Good Laboratory Practices (GLP) generally refers to a quality system of management controls for laboratories and research organizations that regulates how non-clinical safety studies are planned, performed, monitored, recorded, reported and archived.  Many Bioanalytical laboratories have also chosen to follow GLP as the quality system for the control of testing for pharmacokinetic and other clinical studies.  This ensures the consistency and reliability of results for submissions to the USFDA, the OECD and other national organizations.

This three-day GLP training course is designed for all Scientists (managerial and laboratory), Regulatory Affairs and Compliance personnel who are active in regulated laboratory studies.  It will be of most benefit to professionals whose job function necessitates the generation, evaluation, assurance and submission of laboratory data to regulatory agencies.  Principal Investigators, Study Directors, Study Monitors and professionals aspiring to these positions will derive benefit from this course.

 

Also included is a discussion of functions related to quality assurance unit responsibilities and the need to effectively audit laboratory activities and data for regulatory compliance. Successful audits are often a result of good planning and interaction between QA staff and management. This course will cover a range of audit activities (internal and external) including responsibilities and requirements for compliance including those required at collaborator sites, records management, GLP special requirements, archiving of data and inspections.

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, Inc.
Invited Speakers:

Dr. Kenneth Cleaver is a highly regarded GLP consultant with over 20 years of industry experience. Since 2001, Dr. Cleaver has taught GLP courses and consulted for a variety of organizations. These include Medtronic, M.D. Anderson Cancer Institute, Exxon-Mobil, Hewlett-Packard and Phillips Oral Care. His experience covers such disciplines as basic research, drug re-formulation, medical device development, contract laboratory testing and environmental studies.

Prior to 2001, Dr. Cleaver served as Vice President of Product Development for Novadel (formerly Flemington Pharmaceutical). Before this, he was a consultant with Medical Development Quality Associates and directed the Quality Assurance Unit at Oread Laboratories – a CRO specialized in distribution, metabolism and excretion of drug substances in various animal species. He has also run several toxicology studies in mice, rats, guinea pigs and dogs for such clients as Upjohn Laboratories, Marion Laboratories, Bristol-Myers Squibb and Burroughs-Wellcome.

Dr. Cleaver received his Ph.D. in Pharmaceutics and M.A. in Organic Chemistry from Temple University. He received his B.S. in Chemistry from Albright College.

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