Last week, I served as the keynote quality speaker at the international Personal Care Products Council's 2011 Science Symposium in Newark, New Jersey. The turnout was very impressive - every where I went, rooms were packed - more so than any conference I've attended in recent years. A great number of the attendees had a solid grasp of the challenges they faced and were looking for real-world solutions and advice. It's always a good sign when the majority of conference attendees are managers, directors and vice-presidents.
One positive comment that came up with everyone I spoke to was an appreciation for how the PCP Council had organized the symposium. Far too many conferences force attendees to choose amongst specialized niche tracks - quality issues just for device makers, quality issues just for biologics, quality issues for supplier management, and so on. It's always been my opinion that while such niche specialty tracks have the potential to better focus the advice provided, the reality is that an attendee ends up missing out on far too many cross-industry best practices and missing key learnings from how other industries are tackling similar challenges.
The PCP Council's symposium consolidated the tracks into two options: one focused just on scientific-oriented challenges and speakers, and one focused on quality and regulatory issues and speakers. Breaks and lunches were timed together to ensure that attendees mingled and networked with each other, the speakers and the sponsors in one central refreshment area.
Not being a microbiologist, I happily attended the quality and regulatory workshop and listened to several fantastic talks on cleaning validation best practices and the current state of GMPs in the EU. Now, cleaning validation is not exactly a topic that grabs my interest, but I have to admit that the two speakers were not only excellent but they really brought to life the challenges and the available solutions with stories, diagrams, and step-by-step suggestions.
Karyn Campbell from the FDA gave a superb overview of the new process validation guidance, discussing not only the structure of how process validation should be conducted (from process design to process qualification to continuous process verification), but the intent behind the revisions. She noted that the new process validation really takes as its core an almost quality-by-design-"esque" mindset that focuses on controlling the process from its initial conception through on-going monitoring and continuous improvement. She noted that FDA really likes how some companies are using continuous process verification through "out of trend" results to avoid "out of spec" problems, to continuously monitor processes to correct for process drift over time.
There were, of course, the usual presentations on current challenges such as dealing with suppliers, but these didn't arouse that much audience interest because I think we all recognize the challenges we face. Personally, I'd like to see more speakers stop delving into just the challenges and start offering specific supplier quality tips, advice and solutions. Now, let me step off my soapbox and contrast that with an experience I'd had the day beforehand, serving on a supplier quality management expert panel at the Intermountain Biomedical Association's annual conference in Salt Lake City, Utah.
Myself and the other two panel members (a former FDA director and a current biomedical firm director) walked attendees through a number of specific steps to take to improve supplier oversight programs from the 20th century to the 21st century. We covered a lot of ground, from key tactics stemming from the heparin scandal (see my newsletter, SmarterCompliance #43, July 2010) to making better use of the Internet when it comes to supplier due diligence and monitoring. If you attended the risk-based supplier management workshop I gave in August with my friend Dan O'Leary, then you know exactly the type of "do-this, don't-do-that, this-seems-to-work-better-than-that-tactic" type of advice that we started to get into at the IBA conference panel discussion.
As a side note, if you were unable to attend either the August workshop or the IBA panel discussion, you can request the workshop for your company by contacting me directly.
As I thought about the IBA panel experience while listening to several of the speakers simply review supplier management challenges at the PCP symposium, I realized that a conference planner has to walk the same sort of line that a good speaker treads: you need to give enough valuable information that you satisfy attendees, keep them interested and encourage them to come back, but not too much so that an attendee interacts with you once, never to contact you again. It's a line that's impossible to balance across without slipping to one side or the other.
I look forward to attending the PCP symposium and the IBA conference next year. I hope I'll see you there.