
View Course Agenda

Past Participants' Comments:
"This is one of the few courses on the subject of DMFs from which I got useful, definitive information. After most other courses, I wish I hadn’t gone at all because of the work I wasn't getting to. This time, it was well worth it."
Dustin S., Sr. Regulatory Affairs Associate, Noramco
"The workshop at the end of the course was very good & inclusive. A true joy."
Therodore R., Associate Clinical Manager, Astellas Pharma
"Best training course I’ve ever attended! Small classroom approach allows for more dialogue with colleagues. The instructor asked about everyone’s background witch enabled him to tailor content to the audience's needs."
Christina R., Regulatory Affairs, Kerry Bio-Science
"Excellent instructor! Encouraged questions and answered them clearly. Small class allowed for effective Q&A."
Teresa M., Regulatory Manager-Pharma, Kerry Bio-Science
"The Course Director's presentation was clear and interesting. His interaction with the group was stimulating and responses to questions were well thought out and on target. A terrific presentation."
Peter S., Associate Director, Genzyme
"The course was absolutely perfect! It was especially nice that the Course Director knew about both EU and US regulations."
Christine O., Regulatory Associate, Novo Nordisk
"The Course Director did an excellent job in presenting and discussing the subject of DMF. This course and the Course Director have both exceeded my expectations."
Farid S., Director, Quality, Winpak Packaging
"I am very happy with the DMF course material and related discussion. This course has given me added confidence to successfully approach a Drug Master File. To aid development of my knowledge, I intend on seeking additional training from CfPIE to develop my R.A. credentials."
Annie Y., RA Manager, Tech Group Europe
"This course and director really made the entire process so much clearer. Well worth the investment!"
Anita N., Quality Coordinator – Regulatory Group, Mallinckrodt Baker, Inc.
“I found this class to be extremely informative. I came into this training knowing only how to archive this type of document. This course has broadened my knowledge of what a DMF is and the reason for these types of documents. I am very excited to go back to my office and review the DMFs we currently have in our archives."
Priscilla D., Document Coordinator, Otsuka America
"The Course Director presented the material in a clear and concise manner. His use of examples that everyone can relate to makes the material much more clear and more poignant. In addition, the setting and amenities of the facility added to the comfort and ease of the program...kudos!"
Charlie, Vice President, CSCS
