biosink: Current Good Laboratory Practices & Current Good Manufacturing Practices

Current Good Laboratory Practices & Current Good Manufacturing Practices - A Basic Primer: "

Current Good Laboratory Practices & Current Good Manufacturing Practices - A Basic Primer

Who Should Attend

The course is designed for all scientists (managerial and laboratory) and professionals in the biotechnology, biopharmaceutical, pharmaceutical and agrochemicals industries, whose job function necessitates the generation, evaluation and assurance of data that will be incorporated in regulatory filings with the US FDA and similar European organizations. It will benefit professionals who are new to the pharmaceutical industry and also those who need refresher training.

Learning Objectives

Upon completion of this course, attendees involved in establishing and assuring that Good Laboratory / Good Manufacturing Practice guidelines are in effect within their organization will have a thorough understanding of the current regulations (mandated by the USFDA and the International Conference on Harmonization), the necessity of rigorously implementing them in their groups, monitoring compliance in their and the collaborator’s organizations and incorporating this thinking in all scientific matters. The course will also discuss the consequences of non-compliance.

Course Description

This course is intended to give participants an introduction to Good Laboratory / Good Manufacturing Practice regulations and their application to laboratory studies and for manufacturing. This course will also 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 needs 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

“This course was very helpful! The Desmond was also great and enhanced the overall experience. The Instructor was knowledgeable and engaging with concrete examples. I would definitely recommend this course to others."
Kristen P., CRO Monitor, Wyeth

“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