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Avoiding Pharmaceutical and Biopharmaceutical Data Integrity Problems

 
  July 06, 2016  
     
 
CfPA-The Center for Professional Advancement, 90 Minute Accredited Online Training
August 4, 2016 at 11:00 a.m.–12:30 p.m. (ET)


Who Should Attend?
This timely online training course will benefit professionals in the following FDA-regulated industries: Pharmaceuticals, Biopharmaceuticals, Vaccines, Cellular and Tissue Therapies and other Biologics, PET Drugs.

This online training course will be of benefit to all persons whose span of responsibility includes compliance with the U.S. Food and Drug Administration’s (FDA’s) Current Good Manufacturing and Good Tissue Practice Regulations (CGMPs and CGTPs) including, but not limited to, scientists and other professionals in: Quality Assurance, Quality Control, Regulatory Affairs, Compliance, Development, Manufacturing and Production, Auditing. The course will also benefit senior management staff of FDA-regulated companies. 

Course Description
“In recent years,” states the Agency, “FDA has increasingly observed CGMP violations involving data integrity during CGMP inspections.” This intensive 90-minute accredited online training course focuses on how you can look for, assess, and correct possible Data Integrity issues at your firm, and demonstrate to FDA that your CGMP data are ALCOA (attributable, legible, contemporaneously-recorded, original or a true copy, accurate). The centerpiece of our discussions will be a new Draft Guidance for Industry published by FDA which expresses the Agency’s current thinking on this crucial subject.
 
 
Organized by: CfPA-The Center for Professional Advancement
Invited Speakers:
Thomas J Pritchett, Ph.D., Consultant

In his more than 25 years working with the US, European, Canadian and other pharmaceutical, biopharmaceutical, and biologics industries, Dr. Tom Pritchett has gained considerable experience in most aspects of Quality Assurance, Quality Control and CGTP and CGMP Compliance for both investigational and marketed products. He is also an experienced teacher, and has been directing courses for the Center for Professional Advancement since 1995. In addition, Dr. Pritchett has provided training sessions for the US FDA, for the US National Institutes of Health (NIH), and for officials, regulators, and industry professionals of countries in the Gulf Cooperation Council (GCC). Dr. Pritchett is also an industry consultant and 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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