I’ll be a Session Speaker at the 2019 ASQ Audit Conference in Orlando, Florida on 17-18 October. My sessions “Lessons on Change Management from a Consent Decree Site” and “ Auditing the Quality System for Data integrity”, two topics I hope folks known I am passionate about.
The Food, Drug and Cosmetic Division is sponsoring a track of speakers and I volunteered to participate. I look forward to meeting anyone who is at the conference.
With June almost over a look at the five top views for 2019. Not all of these were written in 2019, but I find it interesting what folks keep ending up at my blog to read.
- FDA signals – no such thing as a planned deviation: Since I wrote this has been a constant source of hits, mostly driven by search engines. I always feel like I should do a follow-up, but not sure what to say beyond – don’t do planned deviations, temporary changes belong in the change control system.
- Empathy and Feedback as part of Quality Culture: The continued popularity of this post since I wrote it in March has driven a lot of the things I am writing lately.
- Effective Change Management: Change management and change control are part of my core skill set and I’m gratified that this post gets a lot of hits. I wonder if I should build it into some sort of expanded master class, but I keep feeling I already have.
- Review of Audit Trails: Data Integrity is so critical these days. I should write more on the subject.
- Risk Management is about reducing uncertainty: This post really captures a lot of the stuff I am thinking about and driving action on at work.
Thinking back to my SWOT, and the ACORN test I did at the end of 2018, I feel fairly good about the first six months. I certainly wish I found time to blog more often, but that seems doable. And like most bloggers, I still am looking for ways to increase engagement with my posts and to spark conversations.
Thoughts from the pre-day at ASQ World Conference of Quality Improvement. May become a more meaty post.
Food, Drug and Cosmetic Division (FDC)
- What separates this division for the biomedical division? The commonalities between food, drug, cosmetics and medical devices are more pronounced in the US with the common regulatory responsibilities. But I have trouble seeing the cosmetics industry more closely aligned to me than a medical device.
- I think there is more commonality between cosmetics and type 1 and drugs and type 3 than there is often between drug and cosmetics. Though the drug to cosmetic or drug to food is a slippery slope.
- The type of conferences the FDC division attends tend to be more focused on nutrients and OTC then cutting edge bio it feels like.
- I’d love to see a SWOT, force-field analysis and definitely an X-matrix as they discuss strategic plan.
- Yep, ASQ is not getting technology. Oh dear, I feel what they really want is a stack exchange (ASQ should totally have licensed stack exchange instead of whatever is powering my.ASQ)
- Love to understand the decrease in CPGP. I think there is a a value statement the ASQ has failed to make.
- Would like to learn more about the new CHA BoK. Will it recognize the greater value of the tool outside of food industry? Can it do that without weakening the BoK’s value for the food industry?
- Still no training for the CPGP. Still volunteering and hoping to get called on. Part of forming that value statement will need to be good training.
- Maybe I should be glad my attempts to volunteer this year never went anywhere. Lots of talk on expense reports and I am super bad at expense reports.
- Pins. Between badges and ribbons and pins I feel like I am back in the boy scouts.
- Still not feeling the commitment to transparency that should be at the heart of a quality organization
- Change is hard
- Technology is super hard. But really we mean to get it this year (how about a smart phone app, pretty please)
- I think I like the new membership structure but still not sure how technical organizations will work
At ASQ BOSCON 2019 I spoke on “Knowledge management & effective change management.” From my proposal:
An effective change management system includes active knowledge management, leveraging existing process and product knowledge; capturing new knowledge gained during implementation of the change; and, transferring that knowledge in appropriate ways to all stakeholders. This session will focus on three key areas of knowledge management as it enables change. It will provide an understanding of the principles of knowledge management, including: transforming data into information; the acquisition and creation of knowledge; and the some shared best practices for dissemination and using information and knowledge for the purpose of change management and building a quality culture.
Warren is one of several senators eyeing White House runs who have introduced bills targeting the pharmaceutical industry. Just last week, Sens. Jeff Merkley (D-Ore.), Kamala Harris (D-Calif.) and Amy Klobuchar (D.-Minn.) introduced the CURE High Drug Prices Act, which would allow the federal government to block price increases on certain drugs. Merkley put forward separate legislation, the Low Drug Prices Act, weeks earlier. And Sen. Bernie Sanders (I-Vt.) introduced his own bill, the Prescription Drug Price Relief Act, in November.
The flurry of bills suggests that the powerful pharmaceutical industry will be a major populist target during the Democratic presidential primary and possibly the general election, as millions of Americans struggle with rising health care costs.
— Read on www.politico.com/story/2018/12/17/elizabeth-warren-bill-drug-manufacturing-prices-1067916
An Office of Drug Manufacturing. That could be interesting.