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

February, me and the ASQ

February is a busy month for me and the ASQ.

February 11th – Boston Section meeting on “Mixed Reality in Quality 4.0”

Augmented Reality and Virtual Reality are more than just a science fiction dream, with the market expected to exceed $50 billion by 2024.

The technology promises that workers will have more information about the task at hand, which makes them more efficient and productive. In this session we will explore several opportunities the technologies present and provide a glimpse on how Thermo Fisher Scientific is working with key technology providers to implement on the pharmaceutical manufacturing floor.

It will be fun to discuss some of the fun stuff I’m working on at work. Thermo Fisher is hosting the event at the Waltham facility, which I haven’t even visited yet. Should be a fun time.

February 23-25, Lean and Six Sigma Conference in Phoenix

At the conference I will be presenting on “Sustaining Change – Executing a Sustainability Plan.” Sustaining change is one of my core competencies, and I’m excited to continue the conversation on this. If you re coming to the conference I look forward to seeing you there.

February 29, Unconference for the Team and Workplace Excellence Forum

What better day to hold an unconference on leap day, an un-day.

We have a stimulating day planned. We will be discussing team excellence and quality culture and contributing to development of a body of knowledge for the Team and Workplace Excellence Forum. The agenda is here.

The Unconference is free to members of the ASQ. For non-ASQ members there is a charge of $15.00 per person for lunch.

Please RSVP by February 24th, so we can reserve a seat for you. We are looking forward to seeing you there. If there is anything you will need or have any questions, please don’t hesitate to let me know. The RSVP is here.

The my.ASQ.org event page is here: https://my.asq.org/communities/events/item/170/60/1568

It is going to be a great way to end the month and I hope you can join us.