FDA Publishes New Field Alert Reporting Draft Guidance
— Read on www.fdalawblog.net/2018/07/fda-publishes-new-field-alert-reporting-draft-guidance/
Month: July 2018
DIY medicines -another compounding pharmacy disaster?
“Meet the Anarchists Making Their Own Medicine” mostly avoids bringing the typical “technology can solve anything” silicon-valley messianic fevor to an interesting idea, that of micro-pharmaceutical manufacturers.
“Unless the system is idiot proof and includes validation of the final product, the user is exposed to a laundry list of rather nasty stuff,” DeMonaco told me in an email. “Widespread use [of Four Thieves’ devices] would provide an entire new category for the Darwin Awards.”
Discussing at the high level the risks of DIY drug synthesis, the article points to compounding pharmacies as a lesson on how to do this right. Not sure I agree, as compounding pharmacies have had a slew of problems in recent years, and frankly quality systems still need improving.
I do think we will see more and more hospitals turn to small scale manufacturing. Hopsitals are more used to the idea of quality systems and can build the encessary systems and processes to do this safely.
FDA Announces Two Initiatives to Modernize Drug Quality Programs | FDA Voice
FDA Announces Two Initiatives to Modernize Drug Quality Programs | FDA Voice
— Read on blogs.fda.gov/fdavoice/index.php/2018/07/fda-announces-two-initiatives-to-modernize-drug-quality-programs/
ASQ to quality professionals – change is hard!
The ASQ has announced the theme for the 2019 World Conference On Quality And Improvement: “Leading Change”.
Change has always been constant, but in today’s digital landscape the pace of change is accelerating at a faster and faster rate. Within this dynamic is the opportunity for quality professionals to lead their organizations through the changes that each is destined to go through.
The focus areas are:
- The Future of Quality
- Managing Change
- Building and Sustaining a Culture of Quality
- Quality Basics
- Advanced Content Master’s Series
For those interested, you can submit your proposal at https://asq.org/conferences/wcqi.
Looking back at the last few years:
- The 2018 theme, was the “Innovation of You,” with focus areas of “Building and Sustaining a Culture of Quality”, “Master’s Series”, “Quality 4.0: The Future of Quality Starts Here”, “Quality Fundamentals in the Digital Age” and “Risk and Change.”
- The 2017 theme was “Grow Your Influence: In the Profession, Through the Organization and Around the World” with focus areas of “Focus on the Customer
Operational Excellence”, “Quality as a Competitive Advantage”, “Quality Fundamentals” and “Risk and Change.”
From this I draw the following opinion:
- Change is perceived as hard
- The future is murky
- Culture of Quality is definitely something important (we might not be sure exactly what it is, but it is important!)
All of which are true. It also iterates what I fundamentally believe is a core function of quality. We drive change, we build a culture of excellence, we help navigate the future.
I enjoyed the 2018 ASQ WCQI in Seattle and will certainly plan on going whether as a speaker again or a participant. While I wish the ASQ would be the perfect organization of my dreams, I do deeply believe that an approach defined in the 2019 focus areas is one that brings a lot of value to any organization.
I have begun recommending co-workers submit this year, and I have a few ideas I am toying with myself. Proposals are due Aug. 17. I encourage you to be contemplating the best practices in your organization and be considering how you can share them with the wider quality world.
Take Control of Your Learning at Work
It’s up to you to set aside the necessary time to learn.
— Read on hbr.org/2018/07/take-control-of-your-learning-at-work
Spot on In many ways. I would advocate that is is a key part of any knowledge management system to set up the appropriate to ensure continual learning is a fact of life.