This 2-day course is designed to follow PTI's introductory level course, but may also be taken as a stand-alone class for attendees with experience in aspects of biotechnology. Details will be presented on technical issues in designing and executing specific critical analytical studies. Practical examples will be provided as illustration for key studies and ample time will be allowed for discussion designs and outcomes. Finally, tips on the suitable generation of internal study reports and the presentation of data for regulatory dossiers will be given.
All attendees will be given a USB drive containing over 1800 global CMC (Quality) regulatory guidance documents, industry white papers and compliance warning letters associated with the development and commercialization of biopharma and biosimilar products.
"Nadine was very good and really went into a lot of detail. I really liked the fact we were given USB sticks with the course content. Excellent course!"
Tamara Mandusic Nazor, Quality Assessor, HALMED
"The trainer was very clear, interesting and an experienced trainer. The topics were very interesting, especially the HCP methods. The literature contained in the USB sticks was also very helpful."
Petra Sokol, Quality Assessor, HALMED
"The course content fitted well with our company's current challenges. I found the course content very relevant and I had also know the trainer from industry white papers."
Analytics Researcher, ILKOGEN
"The trainer was extremely enthusiastic and knowledgeable and managed to explain everything in a simple way. Nadine was also ready to stay over-time to explain and discuss any issues; she was really accommodating."
Bioprocessing Trainer, National Institute for Bioprocessing Research and Training
The course trainer was very knowledgeable and covered topics to a good level of depth.
It was great that there was real life examples and the trainer conveyed their ability to teach the class well on the topic.
There was comprehensive instruction about validation of method.