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Current Good Tissue Practices: Achieving and Maintaining FDA Compliance

 
  June 06, 2016  
     
 
CfPA-The Center for Professional Advancement, Burlingame, CA
October 13-14, 2016


Who Should Attend?
This course will benefit anyone who works for human cell, tissue, and cellular and tissue-based product firms which must comply with CGTP regulations. This includes, but is not limited to:

  • Quality Assurance, Quality Control, and Regulatory Affairs professionals
  • Recovery technicians
  • Production and quality assurance supervisors and operators
  • Quality, Production, and Facilities Engineers
  • Managers and Senior managers from Recovery Agents, Cellular and Tissue 
     Banks, Cellular and Tissue Processors, and Cellular and Tissue Distributors

Course Description
The Current Good Tissue Practice regulations (CGTPs) (21 CFR 1271, specifically Subparts C & D) are essential components of what can appear to be a labyrinthine plethora of essential legal requirements which manufacturers, processors and distributors of Human Cells, Tissues, and Cellular and Tissue-based Products (HCT/Ps) must follow. Other regulations are found in other subparts of 21 CFR 1271, 21 CFR 207/210/211, various subparts of 21 CFR 800 and more. In this course, we will answer the crucial question: Who must follow which regulations, why, when, where, and how? Next, we will go through the CGTPs and the requirements and expectations they create in detail, always with an eye to their practical application. Along the way, we will delve into many of the most common violations for which various types of HCT/P firms are cited.
 
 
Organized by: CfPA-The Center for Professional Advancement
Invited Speakers:
Thomas J Pritchett, Ph.D.; Consultant

Thomas J Pritchett, Ph.D., has worked with US, European, Canadian and other pharmaceutical, biopharmaceutical, and biologics industries for more than 25 years, during which he has gained considerable experience in regulatory and technical aspects of Quality Assurance, Quality Control and CGMP Compliance for both investigational and marketed products. He is also an experienced teacher, and has been directing courses for the CfPA since 1995. In addition, Dr. Pritchett has provided training sessions for the US FDA, the NIH, and for regulators and industry professionals in the Gulf Cooperation Council (GCC). Dr. Pritchett is an active industry consultant, sits on the Editorial Advisory board of BioProcess International, and is the co-founder/publisher of the newsletter BioQuality (www.bioquality.biz).
 
Deadline for Abstracts: n/a
 
Registration: Please click here for registration information.
E-mail: jmorbit@cfpa.com
 
   
 
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