Day 2- Monday- Session Reviews

The Keynote Address lead off the meeting and several speakers provided their thoughts on our industry; Jane R. Brown, of GlaxoSmithKline, Ron Branning of Genentech, Nat Ricciardi, President of Pfizer Global Manufacturing, (first half) (second half), and finally, Bob A Spina of Walt Disney World.

I was talking to Marc Steinman about the sessions and he was very impressed with the Keynote Address by Mr. Spina…Marc noted that Disney employs more than twice the number of people who work for his company worldwide…and this was just at the Orlando site…here is the link to a review on the ISPE Annual Meeting Blog…Marc took note of the way Disney looks for new ideas from it’s front-line employees…the post captures some of this with some great points about the sources of innovation and new ideas in large organizations…good issues we should all be thinking about…


I spent the afternoon attending sessions…as usual, I tend to jump in and out of various presentations...trying to get my money’s worth, I guess...

Quality By Design - What the ICH Guideline Q8 Says About QBD6

I hadn’t planned on attending this session, but have been thinking that Q8 is an important issue...not worth all day, but the first session was noted as an FDA overview so I thought that might be worth a few minutes...

When I poked my head in, Elaine M. Morefield, PhD, FDA/CDER/ONDC was just being introduced. Her presentation was an FDA perspective on the Q8 Quality by Design program underway at the FDA. It is always good to get feedback from a regulatory viewpoint...A good presentation which was very well attended...Obviously, many questions still exist around the topic of "Design Space"...

From there I jumped to the Vaccine Facilities of the Futuresession, which was one of my main interests of the meeting...

Anand Ekambaram, Associate Director, Merck & Co Inc, provided a great presentation regarding a risk- based approach to definition of project requirements and doing both a thoughtful analysis and good job documenting the results…useful for future reference...this is a critical point...if it’s anything like my project work, the amount of turnover in the various organizations involved in executing a project can be quite extensive...

Both of these presentations deserve a more in-depth review, but I am running way behind as it is...when I can gather my notes and get some time I hope to provide a bit more information...

After the afternoon sessions finished up, I grabbed a quick bite for dinner...the evening weather was quite pleasant so I went out for a walk around the resort...

The combination of being up early to travel and the sessions make for a tiring day, so I was back in my room early...

Reviews of Days 3 and 4 to follow…

ISPE Annual Meeting