Boscon 2022

I am pretty excited that Boscon, the local ASQ section’s conference is back on and calling for proposals. So for local folks, a good time to share some best practices and case studies.


BOSCON is an annual quality conference hosted by ASQ Boston. BOSCON is the New England signature event where national and international quality professionals hear speakers discuss different quality topics and network with them. The conference focus for 2022 is Navigating Quality Performance in a post-Pandemic World (Risk management, Impact/risk & mitigation of pandemic on companies, Work-life balance, Resource management, Employee Safety, Virtual/ remote workspace, Customer satisfaction, Supply chain).

Tracks and possible focus

  • Technical Quality tool (CAPA, 5S, SPC, Lean 6 sigma, etc);
  • IT/Software (Cybersecurity, cloud, virtual workspace, etc);
  • Pandemic Supply Chain (Lean reconsidered, Change management);
  • Personnel/People (Work-life balance, resource management).

Not interested in presenting, but want to participate as a volunteer?
Contact Snehal Rane  Snehalrane90@gmail.com BOSCON 2022 Chair

B0SCON 2022 PRESENTATION PROPOSAL FORM

We invite you to submit your proposal(s) for BOSCON 2022 oriented towards one of the track areas above.  Please provide a concise and clear description of your session topic and the values it provides to our attendees. 50 minutes are provided for your presentation and any Q&A.

KEY DATES

  • August 15th => Please complete the form referenced below and submit to both Snehalrane90@gmail.com and dmanalan@alum.mit.edu as soon as possible, and no later than August 15th.
  • September 1st => Applicants will be notified if the submitted proposal was accepted, confirmation requires a signed speaker agreement.
  • September 15th => Sign speaker agreement and submit.
  • October 1st => Submit final set of slides by October 1st.

Fill out the form- Word version at

https://1drv.ms/w/s!Aq7kI8QOQQN5hD-FL4JLDqGKF8yc?e=USkE6y

Thoughts on ISPE 2022 Aseptic Conference

Just finished up the 2022 ISPE Aseptic Conference, and here are a few thoughts.

EU GMP Annex 1 expected in later half of the year

Paul Gustafson, chair of the Pharmaceutical Inspection Co-operation Scheme (PIC/S) and a senior corporate regulatory compliance and enforcement advisor with Health Canada, stated that the plan was to issue the widely anticipated Annex 1 in mid-year 2022. He repeatedly said July to September so that is interesting news and start getting your contamination control strategies going. There will be a one-year period before in force, with 2 years on some of the lyophilizer requirements.

For those keeping track, it retains the provision calling for testing filters used in the sterilization process, pre-use, post-sterilization integrity testing (PUPSIT). The PUPSIT provision “has driven a substantial amount of discussion and has resulted in a number of papers being drafted,” said Gustafson. This was a very gracious understatement, and I have to admit I really admired his Canadian humor.

FDA continues to evaluate COVID inspection measures

Alonza Cruse, Director of the Office of Pharmaceutical Quality Operations at FDA/ORA did a thorough job going through the COVID measures of Remote Regulatory Assessments and Remote Interactive Evaluations and discussed how the agency was in the process of learning how best to do things going forward.

He also clearly state how they were continuing to get back to normal inspections and discussed new personnel in foreign offices, such as India.

Highlights from Panels

One of my favorite panels was Jo Ann Jacobs and Kara Vogt speaking on “Building Resiliency into Single-Use-Technology Systems” They laid out some good work they are doing as part of a startup to design good functional equivalency and supplier management, obviously learning from PPAP and similar measures. Quite well done. While it leans heavily into my own practice around functional equivalency it was good to see such a rock-solid implementation, and I felt like I learned a few good ideas.

I spoke on Contamination Control, Risk Management and the Quality Management System, having a blast doing so. I was followed by Christa Myers who spoke on “Contamination Control Strategy: From Annex 1 Draft Requirements to Implementation in Practice.” We made a good duo and between the two I hope participants got a real solid idea on how to do this contamination control strategy effectively.

I learned a lot about robotics and isolators.

Still a big fan of ISPE’s Women in Pharma.

Conference Attendance

Conference attendance is both an important way to make connections and to grow as a quality leader. I’m here in Phoenix for the ASQ Lean and Six Sigma Conference, and in waiting for the event to begin I have a few thoughts on planning for conferences as part of development.

Plan your conference attendance 6-12 months out, and treat it as a rolling calendar.

Go and do some research on the conferences that make sense to you. It is easy to start with those of your professional organization, like the ASQ. Whenever you come across a conference and it seems to be in your wheel house, add it to the list. You want to pay attention to three key dates: When the conference is, when the registration deadlines tend to be, and when the call- for-speaker periods end. This last one is important because…

Speak at the Conference!

The best way to get value for a conference is to speak at it. Conferences compensate attendance, and that means your organization is much more willing to let you go (and pay for travel). Speaking allows you to talk about the work you, your team and your organization have done. This draws in people who are interested in the problems you are solving, which helps with networking. It serves as advertising, can help recruiting, and can build reputation.

Yes, you can speak at a conference. If you are new to it, speak at a local regional conference first. You get better by doing these, and I’m serious, the opportunity to discuss the issues important to you will be plentiful. Your team has solved problems. You have learned things. This is gold to others! There is nothing more popular than a good case study talk.

The people you meet at the conference will be more valuable then the talks you attend. Talks are usually fairly high level and are targeting a wide audience (yes, even mine). But they do help you identify people with problems similar to yours. And you will learn a lot. A few key tactics:

  1. Introduce yourself to each and every speaker you attend. Ask questions, follow-up, share. As a speaker I treasure these conversations
  2. Never sit by yourself. Sit by someone, introduce yourself and talk. Even we introverts can do this, and you will be amazed by what you learn this way.
  3. Engage in the hallway track – those impromptu conversations in the hall can often become the main event (well other than your presentation of course)

Make sure to take notes and share them. With your team back home, with the world. I will always take 3-4 key things I learned and do a lunch-and-learn or coffe klatch at work. I also like to do blog posts and share with the world. This will help solidify your key take aways and continue those excellent conversations.

Remember that conference attendance is part of your development. Do a retrospective and determine what went well, what was valuable, was it as valuable as missing those days of work would have been? Use that learning for the next conference. Take an iterative approach and plan for the next engagement.

Understanding the Levers of Change

As part of my presentation “Sustaining Change – Executing a Sustainability Plan” at the ASQ Lean and Six Sigma Conference tomorrow I’ll be talking about levers of change.

Understanding the change landscape

Change Management practitioners usually talk about seven levers:

  1. Infrastructure – Investing in the tools, processes, and other resources that employees need to be successful with the change initiative.
  2. Walk the Talk – active leadership is about ownership; it includes making the business case clear, modeling behaviors, clearing obstacles and making course corrections.
  3. Reward and Recognition – acknowledgement and compensation for employees who work to move the initiative forward
  4. Mass Exposure – getting out information about the change through broadcast messages and other communication pathways
  5. Personal Contacts – creating opportunities for advocates to share their experience of the change with peers who feel disengaged
  6. Outside advocates – bringing in resources (internal or external) to gain expertise for the change initiative
  7. Shift Resisters – moving people to areas less affected by the initiative.
7 levers of change