FDA Draft Guidance on “Considerations for Complying with 21 CFR 211.110”

Usually I expect the FDA to publish some basic primer material as a webinar, so I was a little surprised when “Considerations for Complying With 21 CFR 211.110” was recently published as a draft. I’ve been rereading it, looking for what is actually worthy of a guidance here, and quite frankly, struggling.

It literally is a refresher course on 21CFR211.110. Maybe I should read it as “No we were serious about ICH Q8 and critical quality attributes.” Or maybe it is just the result of one too many bad Type C meetings lately.

Anyway, good refresher on product quality, in-process controls and samples. Still I think this would be better as a webinar with some graphics. Maybe I’ll better understand why this was published based on what sort of crazy comments are made and I can scratch my head and wonder what shenanigans some of these companies are up to.

Understanding Policies

The article “Research: Do New Hires Really Understand Your Policies?” by Rachel Schlund and Vanessa Bohns in HBR does a great job discussing consent that I think have real ramifications on GMP training, especially of the read-and-understood variety. Really gets me thinking on GxP orientation and the building of informed consent.

Building Effective Consent

1. Transparent Communication

Provide clear, detailed information about the why’s.

2. Staged Introduction

Instead of overwhelming new hires with all that GxP training at once, introduce them gradually over time. This approach gives employees the opportunity to digest and comprehend each requirement individually.

3. Interactive Training Sessions

Conduct engaging training sessions that explain the rationale behind each major requirement set and allow employees to ask questions and voice concerns.

4. Regular Policy Reviews

Implement periodic reviews with employees to ensure ongoing understanding and address any evolving concerns or questions.

5. Clear Benefits Communication

Explain the benefits of each requirement to the employee and the organization, helping new hires understand the value and purpose behind the requirements.

Dangers of De-Regulation

Nothing makes me decide someone is an unserious thinker than the line “There are too many regulations” when discussing drug development and manufacturing. Okay, which one? Point to me the regulation you want to get rid of? Because frankly they all exist mostly as reactions to the crap some corporation got up to.

I am going to be honest. I don’t trust corporations to do the right thing. Otherwise we wouldn’t have problems like we see in OTC and consumer goods. Just look at this recent article on cancer causing shampoos, sunscreens and tampons. And that is the tip of the iceberg if you ask me. Don’t even get me started on the risks in generics coming from China and India. Or the mess that is the supplement industry.

So definitely put me in the category of regulations are a good thing. Are some poorly written? Sure. Are there some that need updating? Definitely. But as a whole 21CFR chapter 1 is a pretty decent set of regulations (don’t ask me about the other chapters, I rarely use them). The European Eudralex, pretty straightforward (okay I would get rid of QPs and RPs and all the rest but that is a cultural thing).

I personally think we don’t go far enough. I want to write the regulation that requires every c-suite in every pharma, med device, OTC, consumer goods, supplement and food company to do an intense reading of the Jungle and then quarterly restorative justice sessions with victims of badly executed decision making. I want to see a regulation makes executives and board members truly accountable. I want to stop reading horror stories and seeing recalls.

Trusting the Journey: When Uncertainty is a Feature

I spend a lot of time discussing uncertainty and how to address it in our quality system and within our organization. However, we often find ourselves at a crossroads, faced with uncertainty and the unknown in our careers – certainly, the last few years have been hard in biotech. My current approach has been to reframe this uncertainty not as an obstacle but as a feature of my journey—something it might have taken me 54 years to learn. I am striving to embrace the concept of “trusting the process” personally and as a quality practitioner so I can navigate life’s twists and turns with greater ease and purpose. As we go into the New Year, here are my current approaches.

The Power of Small Steps

If you are like me, it is easy to get lost in the day-to-day pressures of work. There is always a new issue, a new course correction. It is easy to focus on the overwhelming big picture to our next best steps and forget that the journey counts. My QA problem-solving self often wants to focus on problem-solving and forgets that we must strike a balance between action and acceptance, recognizing that while we can’t control every outcome, we can control our response to each situation. I am working to maintain agency in the present moment while surrendering to the unfolding path ahead.

Embracing Uncertainty as a Catalyst for Growth

Uncertainty, often viewed as a source of anxiety, can actually be a powerful catalyst for growth and innovation. By reframing uncertainty as a feature, we can open ourselves up to new possibilities and unexpected opportunities. This mindset shift encourages us to:

  1. Remain curious and open-minded
  2. Adapt more readily to changing circumstances
  3. Cultivate resilience in the face of challenges

The Art of Experimentation

One practical way to embrace uncertainty is through the practice of running small experiments. These controlled tests allow us to:

  • Gather quick feedback
  • Minimize risk
  • Foster creativity and innovation

We create a culture of continuous learning and improvement by incorporating regular experimentation into our personal and professional lives. This approach is particularly valuable when balancing the demands of serving an organization while pursuing personal growth.

Balancing Service and Growth

The challenge of running small experiments while fulfilling organizational responsibilities is common. Here are some strategies to help strike that balance:

  1. Integrate experiments into daily work: Look for opportunities to test new ideas or approaches within your existing projects and responsibilities.
  2. Time-box your experiments: Set aside specific, limited time periods for experimentation to ensure it doesn’t interfere with core duties.
  3. Communicate with stakeholders: Share your experimental approach, highlighting how it can benefit.
  4. Learn from successes and failures: Treat every experiment as a learning opportunity, regardless of the outcome.
  5. Start small and scale up: Begin with low-risk, high-potential experiments and gradually expand based on results and buy-in.

Cultivating Trust in the Process

Trusting the journey is not about blind faith or passivity. Instead, it’s about developing a deep relationship with your wisdom and decision-making process. This trust is built over time through:

  • Consistent self-reflection
  • Recognizing patterns in your choices and their outcomes
  • Staying connected to your core values and goals
  • Celebrating small wins and learning from setbacks

As you cultivate this trust, you’ll find yourself better equipped to navigate uncertainty confidently and gracefully.

Embracing the Journey

Trusting the journey can feel counterintuitive in a world that often demands certainty and immediate results. However, by embracing uncertainty as a feature of our growth process, we open ourselves to a richer, more fulfilling experience. Through small experiments, mindful action, and a willingness to surrender to the unknown, we can create a life and career that is both purposeful and adaptable.

Remember, the journey itself is where true growth and discovery happen. By trusting the process and focusing on our next best steps, we can navigate the complexities of life with greater ease and authenticity. So, take that first step, run that small experiment, and trust that the journey will unfold in ways you may never have imagined.

This is my New Year’s plan: to continue to apply to my personal space the skills and mindsets that have made my career so fruitful.