PTI's TRAINING PROGRAMS ON SOLID DOSAGE FORMS
PROGRAM TITLE:
A 5-Day Modular and Case Study Oriented
Training Program on
FORMULATION & PROCESS DEVELOPMENT
FOR ORAL DOSAGE FORMSWhen was it offered?
April 25-30, 2004
Where was the location?
Nassau Inn, Princeton, New Jersey
COURSE EVALUATION Summary of Course Evaluation
Summary of Location (Hotel, Meal, etc) Evaluation
Technical Content
Presentation Speed
Quality of Visual Aid
Quality of Handouts
Opportunity to Discuss with a Speaker
Overall Program Rating
Which Presentation(s) did you like best?
Which Presentation(s) did you like least and could be omitted from future programs?
Which speaker(s) did you lIke best?
Did the course meet your overall expectations? If not, why?
Additional Comments Related to Hotel/Lecture Room/Meals etc.
Suggestion for new courses by PTI?
Additional Comments?
Excellent
(%)Very Good
(%)Good
(%)Fair
(%)Poor
(%)Technical Content 48 38 14 0 0 Presentation Speed 10 43 43 5 0 Quality of Visual Aid 43 38 19 0 0 Quality of Handouts 38 38 24 0 0 Your opportunity to interact with speakers 67 24 10 0 0 Overall Programming Rating 38 48 14 0 0
Excellent
(%)Very Good
(%)Good
(%)Fair
(%)Poor
(%)Lecture Room 5 47 42 5 0 Coffee Break 26 21 42 11 0 Suitability of Location 21 79 0 0 0 Hotel Room 5 47 42 5 0 Meals in Hotel 16 11 63 11 0 Hotel Service 16 37 42 0 5 “Speakers generally very knowledgeable”
“I expected more in-depth dealing of pharmaceutical unit processes, especially their scale-up”
“Very good, but too much for one course”
“The content was very rich and diversified.”
“All aspects of solid oral dose for development covered well in depth and in a scientific and orderly manner”
“Some presentations too basic knowledge. i.e, coating (Aulton)”
“I enjoyed the course”
“Good overview”
“More focus on process”
“Sometimes too much information for the time allocated”
“Cramming too many presentations in the time slots”
“Presentations often very long. A short break in the middle of a long presentation might be helpful.”
“Need to reduce the amount of information, and concentrate in one aspect rather than multiple-aspects”
“Very good, but the speed of some very interesting topics was too fast, because of the time-line”
“Sometimes, the speakers had a lot of slides, so to finish them, they go fast.”
“All of information presented could have easily been a tow week course”
“First day was very concentrated and could bury someone with very little experience.”
“In general very good, but very much dependent on the speaker and my assessment by my prior knowledge of the topic. However, although this course is for somehow experienced people, I find it very good every time a new topic is introduced to go through quickly some of the basic terms and tehpry.”
“Some speakers spent a long tome in basic topics. Some speakers used to skip their slides. 60%-70% of the speakers were OK”
“Some too fast, some too slow, overall fine except omissions. Shouldn’t cut out SUPAC and VAL related issues if mentioned on agenda. Pace of presentations should be monitored so topics are not dropped”
“Some speakers spend too long time in the beginning, which meant they went very quickly through the last part, which was a shame.
“Sometimes to quick, if the presentation before had been too long”
“Some of the graphs/images hard to read”
“Having access to CD of presentation is very helpful. Perhaps double-sided printouts would help condense contents”
“Excellent slides, but some slides were hard to read”
“Mostly very good. Some presentations “excessively wordy ‘Read only’”
“Maybe a bit more animation for some of the equipment/processes”
“No complaints”
“Excellent, by using a standard format. Good color combination.”
“Excellent”
“I am extremely pleased with the handouts and their quality. I appreciate very much the effort and diligence took by the presenters and coordinators in this”
“Complete and well organized”
“Missing some information, hard to see some of the graphs on the handouts”
“CD was an excellent idea. Plenty of material to take home and study/reference”
“Impressive and the CD is (will be) also very valuable.”
“Electronic copy very good idea; double sided printing would cut down amount of paper; proof hard copy of the slides before printing”
“Speakers were all readily accessible after the presentation and also during the interactive session”
“All speakers were helpful and very informative”
“Program enhanced by involvement of participants and speakers in program”
“Plenty of opportunity to speak with speakers and small group/speakers attended lunch and meals.”
“Interaction with the speakers was excellent. All questions were answered thoroughly. All speakers were experts in their fields.”
“All very accessible and welcoming for a talk in breaks, lunch etc.”
“Sometimes, speakers talked to each other and did not allow audience to ask questions”
“The speakers are very gentle people”
“All speakers were available and answered all the questions. Gary Bubb was very patient while answering questions- even after a long day; David Grant was always available and approachable during the entire program”
“At times, very intense and too much of information were presented in a short time. Some talks were overlapping. However, the case-studies were helpful”
“Just a comment on the amount of information should be reduced”
“Ambitious program given scope and material covered; Quality of presentations mostly good and appropriate …”
“This is a complete course covering most aspects of solid dose development, scale up and manufacture from a formulation and technical prospective. This course would be very helpful for persons new to the industry as well as technical and manufacturing experts. Presentation and quality of the expert systems presented was well done. Scientific principles were affectively put into context as they relate to solid dosage manufacturing.
“Fluid bed drying mechanism should be discussed to give a background on the technology; include more case studies on granulation process”
“I appreciate all of the work and preparation time that was put into this program. It provided a lot to think about and good information.”
“I love the idea of letting the speakers/topics …. And not being to much time controlled. However, there was some detailed discussion that could have been dealt with in between the presentations. So perhaps, a little bit better control of time for each speaker. And sometimes, it affected you PTI-guys presentations, which was a pitty as they were also very (more) interesting.”
“Good information. Defining terms and all acronyms at the beginning or during presentation would be helpful; better to start early on the last day, not later”
“Some presentations were too long”
“Excipients”
“Nanotechnology; Compaction/Compaction Simulators I would have loved to hear more about compaction simulators”
“All”
“The Blending and Flow presentation; The milling presentation”
“Troubleshooting the film-coating process”
“Most very good but some too basic for many attendees”
“The presentations about polymorphism, compaction and choice of excipients”
“All presentations involving granulation”
“Granulation, film coating and mixing”
“Modules 1,2,3,4,8”
“XRD and DSC; Selection of Excipients; Multifunctionality of excipients; mixing and flow; scale up of fluid bed process; SUPAC issues; Instrumentation of Granulators and Tablet Presses”
“Polymorphism; Preformulation; Scale-up; Technology Transfer; New Technologies in Dosage Forms; Expert Systems”
“Technology Transfer”
“Most of them”
“Fluidized bed granulation, the film coating granulations”
“James Prescott - Powder flow; David Jones-Fluid bed granulation; Mike Aulton- Film Coating”
Which Presentation(s) did you like least and could be omitted from future programs?
“None to be omitted”
“Scale-up presentations (did not address the key concerns for me and was looking for more “how to” information”
“Being a preformulation scientist by training, I thought 1 ½ - 2 days was a little bit too much. However, tailoring the presentations should be done based on the diverse audience present.”
“The end point determination presentation”
“Overview of pharmaceutical coating”
“Milling”
“The presentations involving crystals”
“Preformulation presentations were very theoretical however they should not be eliminated since they provided a good basis for the remaining days of the courses.”
“None"
“Dr. Aulton’s presentation should be updated to current storage and testing”
“Nanoparticles and Michael Choi’s presentation on using mathematical modeling to scale-up film coating processes”
“I don’t think is the presentation. I think is the speaker. i.e., there were 2-3 speakers looked and talked as they were a business man (salesman) instead of a scientific speaker.”
“Frank Chrzanowski Presentation”
“Too many presentations on Expert Systems. Best to group them together and give shorter presentation”
“End point determination”
“David Jones, Navnit Shah, Ben Murugesu, Jim Prescott”
“Gary Bubb, Hashim Ahmed, Metin Çelik, David Grant “
“All”
“Navnit Shah, Waseem Malick, Metin Çelik, Stuart Porter”
“Duk Soon Choi, David Jones, James Prescott”
“Metin Çelik, David Jones, Stuart Porter”
” James Prescott”
“Ben – Good interaction. Mike Aulton – Good flow and easy to follow”
“Hashim Ahmed, Aslihan Akkar, Metin Çelik, Waseem Malick, Navnit Shah, David Grant, Stuart Porter”
“All of the speakers were very enthusiastic especially Hashim Ahmed”
“Michael Aulton, Stuart Porter, Juri Holinej and James Prescott”
“James Prescott, Gary Bubb”
“James Prescott: Very convincing and many good information; David Jones: Good, maybe a bit fast; Lynne Taylor; Hashim Ahmed: Many good information; Aslihan Akkar: Interesting topic – convincing presentation; Metin Çelik: I liked the compaction presentation by would have liked a general introduction at the beginning of the presentation”
“Metin Çelik, Hashim Ahmed, David Grant, Stuart Porter, Harry Brittain, James Prescott”
“Metin Çelik”
”James Prescott – Great presentation style, excellent visual aids, great teacher”
“Harry Brittain, David Jones, James Prescott, Mike Aulton, Jurij Holinej, Lynne Taylor”
“James Prescott”
“Yes, exposed to a lot of new strategies and techniques; would have liked it to have been more geared to formulation and what excipients are most appropriate for each technique”.
“Yes, I did get an overall idea about the product process development. Additionally, the various case studies presented in various modules were very appropriate in delivering the content”
“Yes, and more than what I expected.”
“Yes, overall. Some presentations could have been shortened”.
“Yes, it was very helpful for me and I learned a lot from the experience of the speakers”
“Yes, very good overview of all aspects of formulation and process design.”
“Yes. It was a very through seminar. However, late night sessions …. From learning. Sessions should end by 6:00 pm.”
“Yes, pretty much. I think most of the development work/most important technologies covered. And with very good and acknowledged speakers, which is important.”
“Yes, it was great”
“Yes”
“Yes – good overview. Metin and Stuart were very gracious hosts”
“Yes, but too much focus on formulation instead of process development.
Additional Comments Related to Hotel/Lecture Room/Meals etc:
“Missing: Coffee in the lecture room just after lunch and fruit in the afternoon.”
“Had to go to registration desk 2 additional times right after check in. Key mix up upon registration. Given room for occupied room. Major security break. Otherwise service was excellent.”
“Snack at pm break (fruit, nuts) considering course completion time”
“Noise factor high in hotel room, bathroom not set up well (poor design); water difficult to control”
“The bad control of the conditioned air affected my health. I caught a cold which was terrible. Nassau Inn has only one PC-internet. It’s unbelievable – You see… only in a Business Center in a 2004 room hotel in America”
“The hotel was too expensive if you consider the quality of the services. I can find a $90 - $ 100 hotel, with beautiful and friendly services”
“Fruit in breaks would be good. Lunch 1st day was best.”
“Some fruit or cookies or something else to eat on coffee breaks would have been good since it is an intense program, and it would help keep concentration up”
“No high speed internet connection. Temperature in lecture room was a little warm. Noise coming from the kitchen. Hotel room was warm, had to open window to cool off.”
“More comfortable chairs”
“Internet access is too limited for size of hotel and number of guests.. In year 2004???”
“Meals should have been offered with a little bit more variety”
“Afternoon snacks would have been nice”
“Evening sneaks would have been good since we often skipped the dinner break.
“Presentations on newer technologies (PAT related) e.e., NIR etc as applied to process with Case Studies.”
“Encapsulation process overview to process with case studies.”
“It would be great to have real examples from start to finish of formulation steps and choice of excipients and choice of proper process. Real examples makes me apply what I learned better.”
“Cleaning Validation”
“Use of NIR as a development tool and may be in-process tool in this course.”
“On-Line courses especially for foreign students”
“This course could be divided into two separate courses. The first course could be on preformulation and formulation, the second course could be on scale up and production support issues; Controlled Release Technology.”
“The stability session should include presentation regarding stability testing and issues to be aware of on ICH stability programs and stability needed for IND applications.“
“Could be very good idea to give recommendations of more readings/references for each topic/Speaker presentations.”
“Maybe making an evaluation form that evaluates each speaker presentation,”