Learning Objectives

By the end of the course, attendees will have a strong understanding of the compliance requirements for current Good Laboratory Practice (GLP) and Good Manufacturing Practice (GMP) guidelines, and be able to apply compliance protocols in all efforts aimed at generating regulated data.  All participants will gain a fundamental understanding of the basis of the regulations, the necessity of rigorously implementing them in their groups, and incorporating this regimen and proactive thinking in all scientific matters. The consequences of non-compliance will be exemplified.



Course Description

This course is intended to give participants an introduction to Good Laboratory Practice and Good Manufacturing Practice regulations and their application to laboratory studies and manufacturing. This course will provide participants with an understanding of terminology for laboratory studies and the role GLPs/GMPs play in assuring the validity of these studies.  Those attending will also get an understanding of the need for thorough and comprehensive training and documentation.

View Course Agenda

Past Participants' Comments

“Very engaging presenter.  I have never met anyone that knows subject matter so in-depth as this presenter.”
Eva H., GE Healthcare

“The course director is very knowledgeable in this area.  His many years of experience in this field has led to many interesting and meaningful stories that have added depth to his teachings.  The course director is very thorough in his teachings and I am surprised that he was able to cover everything in the syllabus.  This course is very well-designed and I recommend it highly.  Time very well spent for this 2 ½ days of GLP course/workshop.”
Siow F., Principal Scientist, Amgen

“I found the course to be extremely informative and useful as I have never worked in a GMP environment until now, and therefore this course served its purpose.”
Lakshmi R., Senior Research Associate/Quality Specialist, Neose Technologies

"Very timely examples and useful material.  This was my first CfPIE course but I can see why they've become our preferred provider of external training.  Also, the venue was outstanding.  Well done!"
Senior Manager, Bristol Myers

"Even though I am in clinical, many of the GLP/GMP specifics gave me a broader picture of where areas of GXP may intertwine.  It was great to see the “big picture” in the area of pharmaceutical regulations."
Kelly F., Compliance, Wyeth
 
"This course is very good for individuals beginning their understanding of GLP/GMP regulations."
John S., COO, Semafore Pharmaceuticals
 
"Just entering into the field of ‘GxP,’ this course has given me an excellent overview of important issues to cover.  The Course Director was extremely knowledgeable, adding many real-life examples to his teaching.  The handouts will be a useful reference for my future work with GxP issues."
Thomas L., Technical University of Denmark
 
"A very informative and comprehensive cGMP training program!" 
Juan A., Research Program Coordinator, Mount Sinai School of Medicine
 
"This was an excellent course for me as I come from a synthetic chemistry background.  The material was particularly relevant to the manufacture of small molecule drugs and their progress through dosage forms and the drug product in the context of GLP & GMP." 
Kieron W., Associate Director, Edison Pharm