Thanks to our relationship with LSTI and an outstanding team here at Accelovance, we have built a training program that is able to be leveraged moving forward to address an industry need.
My main reason for taking the course was to re-evaluate quality agreements and how to improve our current template. Coming out of this, I would like to compare a few of our supplier quality agreements against the structure and checklist given in the course to see how they align.
Cook Pharmica LLC
All parts of the training were useful, including the topics of Documentation, Change Control and Revisions. I will now review our current Quality Agreement to make sure the requirements are included, and if not, add them.
I took the course to get a better understanding of FDA requirements. As an ISO 9001 registered organization, we need to control and cooperate with suppliers and this gave me some ideas on more formal ways to do that. The webinar was easy to attend with clear audio.
Eldon James, Corp.
I took this course based on our new products that will require submissions. I have a much better understanding now of the different types of submissions and how to plan our strategy. I thought the instructor was wonderful. I have spent time talking with others on this subject and walked away more confused. His approach allowed me to understand and stay engaged. This was very helpful!
I have paid for on-line training classes before and only received a very general explanation of the topic and also found that the presenters were mediocre. Gordon Glass was very knowledgeable and he knew the topic extremely well! I will use the takeaways from this course to communicate the timeline presented for serialization and I have a better understanding of how serialization coding needs to occur.
Regulatory trends as a whole are very important to my organization, specifically my department of IT Validation Services and our counterparts in Compliance. So the entire course was useful, especially the “Top 10” info relating to FDA/MHRA findings. This type of information could influence the direction we take to validate systems and enforce our own compliance. The content and presenter were very good, and the user interface including polling questions were great and very easy to use.
I just wanted to reach out to let you know that my team and I found today’s Pediatric Clinical Trials webinar to be extremely well done. The presenter obviously had a lot of experience and did a great job with getting his message across in a manner that was captivating. We found it to be very worthwhile!
The most useful part was learning what the trends are and finding out where others are in the journey. The information about RCA and also the information on training and knowing that your employees are trained makes for compelling arguments on what we need to do better in management. Looking forward to reading the white paper.
DUSA Pharmaceuticals Inc.
The instructor had a good delivery of the material, presenting real life examples which were easy to relate in our own jobs. The course enabled us to review the areas where the FDA finds most issues to verify that we are in compliance.