Adaptable Leadership Workshop: Women in Pharma® Hosts Transformative Leadership Workshop at 2024 ISPE Annual Meeting & Expo

Moderated by Guido Kremer-van der Kamp, Senior Consultant, Merck Chemicals GmbH, the workshop explored adaptable leadership, team-building techniques, and regulatory interaction, particularly in the context of audits. Key presenters included Yolanda McLean, Senior Director, Quality, Strategy and Operations, Alnylam Pharmaceuticals, and Captain Jill Hammond, Director of Training and Regulatory Science, US Food and Drug Administration (FDA).

The workshop concluded with an in-depth panel discussion that delved into real-world examples of effective audit strategies and the human dynamics of regulatory interactions. Other panelists included:

• Vivianne Arencibia, Vice President, Global Quality Systems and Compliance, Moderna
• June Page, Senior Regulatory Officer, US FDA
• Vivien Santillan, Regional Director, Asia, Novatek International
• Tonya Wilbon, Assistant Director, Division of Industry and Consumer Education and Branch Chief, Center for Devices and Radiological Health, US FDA

Session 1: Adaptable Leadership

Kremer-van der Kamp opened the workshop with a compelling session on adaptable leadership. Drawing from his extensive experience in the global biopharmaceutical industry, Kremer-van der Kamp emphasized that adaptability is crucial in an era marked by constant regulatory and operational changes and stressed that leaders need to view change not as an obstacle but as an opportunity for growth. Change, as he explained, is inevitable in regulatory environments, particularly in the pharmaceutical sector, where evolving standards and unexpected challenges demand flexibility. Leaders who can adapt to these shifts will not only survive but thrive, fostering innovation and continuous improvement within their teams.

A key component of adaptable leadership is resilience. Kremer-van der Kamp pointed out that resilience allows leaders to weather setbacks and maintain focus under pressure. During audits or compliance challenges, leaders must remain calm and composed, setting a positive example for their teams. This resiliency not only boosts team morale, but also builds confidence during high-stakes audits.

Kremer-van der Kamp further discussed the role of proactive leadership. Being proactive, he explained, means anticipating challenges before they arise and taking steps to mitigate them. Whether it’s preparing for a regulatory audit or adjusting to new compliance standards, proactive leaders ensure that their teams are always one step ahead. This strategic foresight allows organizations to maintain operational flow and avoid disruptions.

One of the most valuable takeaways from Kremer-van der Kamp’s session was the focus on fostering a culture of ideation within teams. Leaders should encourage their team members to share new ideas and innovative solutions, which can help navigate complex regulatory landscapes. This open dialogue leads to creative problem-solving and ensures that teams are well-prepared to tackle any challenges that come their way.

Finally, Kremer-van der Kamp highlighted the importance of trust-building in leadership. Trust is the foundation of any successful team, particularly in high-pressure situations like audits. Leaders who build trust within their teams foster an environment where members feel confident and supported. This trust also extends to interactions with regulators, as transparency and honesty build credibility and ensure smoother audits.

Session 2: We Are All Humans

McLean guided the audience through the human aspects of regulatory interactions. In this session, she shared insights into effective audit behavior, demonstrating how building trust between auditors and auditees is critical to compliance and the success of audit outcomes.

McLean emphasized that effective audit behavior is essential to building cooperative and transparent relationships. Audits should not be viewed as confrontational, but as opportunities to collaborate and enhance quality systems. Key to this success is the ability to communicate openly and effectively with auditors, ensuring that all parties are aligned in their goals.

McLean outlined several key behaviors that contribute to positive interactions during audits. Among them:

• Open communication: Clear, ongoing dialogue with auditors ensures that both sides understand each other’s expectations, reducing the likelihood of misunderstandings.
• Transparency: By being transparent and open about processes and challenges, companies can build trust with auditors. This openness proves that there is nothing to hide, fostering a collaborative environment.
• Professionalism and respect: Maintaining a professional demeanor throughout the audit process ensures smooth and productive interactions.
• Avoiding defensiveness: McLean stressed that defensiveness could escalate tensions during an audit. Instead, teams should focus on collaboration, welcoming feedback as an opportunity for improvement.

McLean also highlighted best practices for audit success:

• Ensuring that the right inspection team is selected, including subject matter experts who can speak knowledgeably about the processes being audited.
• Adequately preparing subject matter experts for the audit by ensuring they understand the expectations and can clearly articulate their processes.
• Maintaining transparency throughout the audit process, ensuring that auditors have full access to documentation and information.
• Ensuring accessibility so that auditors feel supported and can ask for additional information as needed.

McLean’s session reinforced the importance of human connection and mutual understanding during audits. By fostering positive interactions and focusing on collaboration, companies can achieve better audit outcomes, enhancing both compliance and operational success.

Session 3: Training for Regulatory Excellence

In her session, Hammond focused on the role of training in achieving regulatory excellence. She provided an in-depth overview of the US FDA’s Compounding Quality Center of Excellence and the strategies the US FDA adopted during the COVID-19 pandemic to continue delivering critical training to industry professionals.

Hammond provided a background on the Compounding Quality Center of Excellence, which was established in 2019 to address the growing need for high-quality compounded drugs produced by outsourcing facilities. These facilities must adhere to Current Good Manufacturing Practices (cGMPs), and the Center plays a crucial role in ensuring compliance.

The mission of the Center is to build the capacity of outsourcing facilities to meet the increasing demands of healthcare providers while maintaining the highest quality standards. Hammond outlined several key initiatives undertaken by the Center, including:

• Training on cGMP and compounding policy
• Conferences to discuss emerging trends and share best practices
• Research and analysis to better understand the challenges facing outsourcing facilities
• Regulatory science to examine complex technical questions and provide clarity

One of the most significant challenges the Center faced was the shift to virtual training during the COVID-19 pandemic. Hammond discussed the strategy change that was implemented to adapt to the worldwide shutdown, ensuring that training could continue uninterrupted. Despite the challenges of virtual delivery, the Center successfully transitioned to online platforms to deliver online instructor-led and self-guided courses. Hammond shared that maintaining engagement and effectiveness in the virtual environment was a top priority, and the Center developed interactive courses to ensure that participants remained involved and enthusiastic.

From 2020–2024, the Compounding Quality Center of Excellence achieved several major milestones under Hammond’s leadership, including:

• Developing and delivering six instructor-led trainings
• Offering virtual training for more than four years, with more than 13,000 course completions
• Expanding educational opportunities through recorded webinars and self-guided online trainings on topics such as environmental monitoring, process validation, and sterile drug compounding

The session offered attendees a comprehensive understanding of how the US FDA has adapted its training programs to meet the evolving needs of the pharmaceutical industry while continuing to deliver high-quality education to professionals.

Panel Discussion: Navigating Audit Challenges

The workshop culminated in an engaging panel discussion, moderated by McLean, bringing together US FDA representatives and compliance experts. This interactive session allowed attendees to ask questions and engage directly with experts about the challenges of audits and regulatory compliance.

Building trust between the US FDA and companies was another essential theme. The panel discussed how transparency is fundamental to this relationship. Trust is built over time through open communication, honesty, and a commitment to improvement.

One of the central themes raised during the discussion was the importance of collaboration. Hammond, Wilbon, and Page emphasized the US FDA’s role is to find gaps to help collaboration, not to penalize. US FDA inspectors want to partner with companies to identify areas for improvement. Audits should be seen as opportunities for learning and growth, rather than confrontations.

The panel highlighted the need for effective communication during audits. Misunderstandings often arise, but panelists stressed the importance of seeking clarity rather than becoming defensive. Asking follow-up questions instead of assuming intentions allows for smoother dialogue. Page particularly emphasized that defensiveness could escalate situations unnecessarily, making audits more challenging for both parties. Approaching audits with openness and a willingness to learn ensures more productive outcomes.

A significant point that emerged was the value of emotional intelligence during audits. Emotions run high on both sides, and maintaining composure, especially during stressful moments, can make a huge difference. Panelists discussed how managing emotional dynamics and creating a calm, supportive environment can ease tensions. Emotional intelligence is critical on both sides to facilitate cooperation and collaboration, Kremer-van der Kamp stated.

One key piece of practical advice shared by the panel was ensuring the right people are in the room during audits. Too often, companies place managers who are not the process experts in front of inspectors, which leads to ineffective communication and delayed responses. Panelists agreed that it is essential to have subject matter experts (SMEs) present—those who are directly involved in the processes under inspection. Arencibia stated that having SMEs present ensures that auditors get accurate, insightful information that can help move the audit along more efficiently.

The concept of involving a technical translator during audits was also discussed. Experiences in the Asia-Pacific region suggest that having someone who can explain complex technical details in simpler terms to auditors—without losing accuracy—can be crucial. This person can bridge communication gaps, ensuring that both parties are on the same page.

Building trust between the US FDA and companies was another essential theme. The panel discussed how transparency is fundamental to this relationship. Auditors and companies need to trust one another, and this trust is built over time through open communication, honesty, and a clear willingness to improve. Keeping logbooks of document requests and questions is important on both sides for maintaining transparency and ensuring smooth progress throughout the audit, Page stated.

Another crucial topic that emerged was about team structure during audits. Successful audit teams typically involve two key players: a quality assurance lead, who oversees communication and manages the flow of information, and a runner, who logs document requests and questions. This combination ensures that audits are handled efficiently, and that no information is missed. The US FDA speakers said this kind of team structure can help train colleagues internally by demonstrating best practices for audit handling.

Panelists discussed the stress involved on both sides during audits, noting that emotions can easily escalate, especially when pressure is high. Emotional intelligence is vital, not only in navigating the stress of the situation, but also in creating an environment of mutual respect and understanding. Arencibia added that human interaction and empathy should always be part of the equation, emphasizing that both regulators and company representatives are under pressure and must work together to manage emotions constructively.

The panel wrapped up with a discussion about how companies can prepare for audits. Confidence comes from preparation, panelists agreed, and this confidence helps foster trust with regulators. Well-prepared teams project competence and readiness, which makes auditors feel reassured. Preparation is not just about technical readiness but about ensuring the right team members are involved, that everyone is briefed and confident, and that processes are well understood.