FDA's Consumer Safety Officers - Jan 29, 2007
Ever wonder about the qualifications of the FDA investigators? The official job title is Consumer Safety Officer. This position is the frontline position of the FDA. CSOs are stationed at over 200 locations throughout the US.Read the official job description. Go towww.gmptrainingsystems.com/asp/resources.aspClick on FDA Resources.GMP Training Systems, Inc.www.GMPTrainingSystems.comServing 1043 clients since 1996Our first GMP Boot Camp in 2007 is filling up fast.February 21 - 22 in Hampton, VA. Learn more atwww.gmptrainingsystems.com/asp/public_workshops.aspPlease forward this post to others in your organization who might benefit.
45 Years of CGMPs - Jan 23, 2007
This year marks the 45th anniversary of the birth of CGMPs. These regulations have reached middle age and are still evolving. Dr. Suzanne White Junod, FDA Historian, wrote an interesting article about the beginnings of CGMP, entitled "God, Motherhood and the Flag" Implementing the First Pharmaceutical Current Good Manufacturing Practices (CGMP's) Regulations
To read this article, go to:
www.gmptrainingsystems.com/asp/resources.aspClick on Timely Resource Articles
GMP Training Systems, Inc.www.GMPTrainingSystems.comServing 1041 clients since 1996Our first GMP Boot Camp in 2007 is filling up fast.February 21 - 22 in Virginia Beach, VA. Learn more atwww.gmptrainingsystems.com/asp/public_workshops.aspPlease forward this post to others in your organization who might benefit.
FDA Halts Sales at Medical Device Company - Jan 15, 2007
GE OEC Medical Systems signed a consent decree with FDA which prohibits the manufacturing and distribution of specified GE OEC Medical Systems X-ray surgical imaging systems at facilities in Salt Lake City, UT, and Lawrence, MA.This action follows a Warning Letter issued to the company in March 2005. Here's one excerpt from the Warning Letter."Our inspection disclosed that your firm discovered that test technicians were not completing original test procedure documentation (Process History Records), but instead were copying test results from one device to another for a period of at least one year.""Not only were test technicians found to be using photocopied device test results as noted above, but supervisory staff and management who reviewed and signed off on these records never caught this practice which occurred for at least one year."Read the entire Warning Letter, FDA's Press Release announcing the Consent Decree, and a newspaper account of this action. Go to:http://www.gmptrainingsystems.com/asp/resources.aspClick on Timely Resource Articles.GMP Training Systems, Inc.www.GMPTrainingSystems.comServing 1039 clients since 1996Our first GMP Boot Camp in 2007 is filling up fast.
February 21 - 22 in Virginia Beach, VA. Learn more at
www.gmptrainingsystems.com/asp/public_workshops.aspPlease forward this post to others in your organization who might benefit.
Congress to Split FDA? - January 8, 2007
Will the new Congress, controlled by the Democrats, split FDA into two agencies? One for Foods and one for the Medical industries?Stripping FDA of the responsibility for Foods regulation could result in a more focused, stronger agency for the regulation of pharmaceuticals and medical devices. Read this insightful article published on January 7. Go to www.gmptrainingsystems.com/asp/resources.aspScroll down to Timely Resource ArticlesGMP Training Systems, Inc.www.GMPTrainingSystems.comServing 1035 clients since 1996Our first GMP Boot Camp in 2007 is scheduled forFebruary 21 - 22 in Virginia Beach, VA. Learn more at www.gmptrainingsystems.com/asp/public_workshops.aspPlease forward this post to others in your organization who might benefit.
Getting Fit in 2007 - Jan 3, 2007
Now that the holidays are behind us, many people's thoughts are on losing unwanted pounds and getting fit. Even the FDA is in this mode. For FDA's tips on How to Lose and Manage Weight, go to www.fda.gov/oc/opacom/hottopics/obesity.htmlGMP Training Systems, Inc.www.GMPTrainingSystems.comServing 1030 clients since 1996
Our first GMP Boot Camp in 2007 is scheduled for
February 21 - 22 in Virginia Beach, VA. Learn more at www.gmptrainingsystems.com/asp/public_workshops.aspPlease forward this post to others in your organization who might benefit.
