Past Participants' Comments:

"This is the most valuable course I have taken in many years. I will be applying what I learned to my current project immediately. The information could not have come at a better time for me. Every section was valuable!"
Duane V., Program Director, Hoffmann-LaRoche
 
"I thought the Course Director did an outstanding job of giving a detailed overview of CMC issues.  The course was rich with practical information and his examples made the information more interesting.  Thanks!"
Dana A., Consultant, The Vaccine Company

"This was the first course that totally deals with all CMC issues from Phase I through to BLA/NDA filing.  I would recommend this course to any start-up biotechnology company on how to design your CMC strategy." 
Warren D., QA Manager, Progen Industries

"Small classroom format is very beneficial to learning.  As a result classroom dynamics were excellent.  Participants felt free to ask questions during the presentation and the ensuing discussions were beneficial to all attendees.  Also, the course director was approachable and answered each question without dismissing seemingly obvious ones.  He understood the diverse disciplines from which the attendees came." 
Maureen M., Manager, Regulatory Affairs, Merck Frosst Canada

"The Course Director was excellent and is extremely knowledgeable in regards to CMC for biopharmaceuticals/biologics. He presented various examples from his experience and answered all questions thoroughly."
Nisha P., Associate Manager, QA Compliance, Centocor

"This course provided a thorough broad understanding of the CMC Regulatory process.  I would highly recommend this course to any technical person who is involved in preparing CMC documents."
Steven M., Senior Program Manager, Bristol-Myers Squibb

"The organization of the course material gave the proper foundation from topic to topic.  Emphasis on critical development issues to avoid delays in the approval of the application were well discussed and rationalized.  As someone with no prior Biologics regulatory background I found this a very good introduction to the complexity of the requirements for BLA/NDA submissions."
David L., Director Regulatory Affairs, Forest Laboratories

"Good in-depth course covering all facets of CMC with biopharmaceutical focus - which is hard to find!"
Greg S., QA Manager, GSK

"This course is a precise overview of current CMC regulatory requirements and approaches taken by industry to meet agency regulations.  Instructors presentation of the topic under the theme of “CMC  continuation” was excellent."
Prakash S., Assoc. Director, Enzon Pharmaceuticals

"Excellent course!  Everyone involved in CMC regulatory compliance related matters needs to attend."
Richard S., Group Director – CMC, Hoffman La Roche

"This course was excellent.  The amount of information is incredible and the content was laid out very well.  Anyone who wants to learn about CMC Regulatory compliance for biopharma & biologics should take this course."
Rodney C., Analytical Validation Specialist, BMS

"The course was very informative and helpful.  The only CMC training program I have found that deals with Biologics and Biotech products."
Anne G., CMC Associate, Intrexon

"Excellent Presentation.  Great, in-depth information for BLA Submissions. I am looking forward to attend more training courses in the future."
Angel G., Regulatory Associate, SAIC