Inside PDA’s Impact: A Conversation with Tita Tavares

In just a few weeks the Parenteral Drug Association (PDA) will be hosting its annual PDA/FDA Joint Regulatory Conference aimed to help those in the world of biotech get insights into regulatory expectations coming down the pipeline relating to manufacturing and quality assurance. I was recently privileged to initiate an engaging discussion with Tita Tavares, the past President of the PDA Capital Area chapter. Her perspective offered a valuable lens through which to understand this global organization’s comprehensive role and its ongoing efforts to shape the future of the life sciences industry.

By Ezekiel Kelley | August 21, 2023

This article is part of our In Conversation series, one of our ongoing People & Places Features. Go indepth with some of the most interesting people making impact across BioBuzz’s growing biohubs.

A Hub for Knowledge: Innovative Conferences and Empowering Education

Tavares painted a vivid picture of PDA as a vital informational pillar within the life sciences sphere. This organization stands out with its nuanced, targeted, and comprehensive approach to knowledge sharing and exchange, providing multifaceted resources tailored for industry professionals. Immediately following the PDA/FDA Joint Regulatory Conference and vendor event, PDA will host a series of two educational events, complementary to one another: PDA 576 Root Cause Investigation for CAPA training course and the 2023 PDA Mastering Deviations workshop.   

“Our workshops and trainings transcend the realm of usual industry lectures,” Tavares stated emphatically. She underscored the unique quality of PDA’s events, specifically the interactive and pragmatic approach that the workshops embody. They tackle complex challenges that professionals encounter in their day-to-day work, such as proven investigation methods and root cause analysis to effectively manage deviations and reinforce the importance of authoring a comprehensive report. These sessions aren’t merely theoretical; they furnish attendees with the robust knowledge and tangible skills they need to address these intricate issues effectively.

Each training and workshop is carefully constructed, reflecting the ever-evolving landscape of the industry. Tavares further elaborated, “We are conscientious in ensuring our content is in line with the current trends and best practices. Our goal is to provide relevant, practical solutions to the challenges within the life sciences domain.”

Then, Tavares pivoted the discussion towards another exciting aspect of PDA’s efforts – the creation of the Technical Report Live virtual events. With palpable enthusiasm, she described this novel initiative: “Imagine blending the energy of MTV’s TRL Live with the depth of a technical subject – that’s our Technical Report Live event.” The event is designed to break the mold and prove that technical knowledge need not be dry or impenetrable. The intent is to create an environment where members can absorb knowledge while being deeply engaged, immersed in the process and with the authors.

This event typifies PDA’s fresh approach to professional knowledge sharing, melding entertainment with technical insights in a dynamic setting. “It’s a rare opportunity to explore complex industry concepts in a format as vibrant and interactive as a live show,” Tavares added. The unique, participatory nature of the event enables a more comprehensive grasp of the subject matter, fostering a more profound connection between PDA’s members and the wealth of knowledge the organization strives to share.

Tavares’ explanation underscored the impressive strides PDA is making as the life sciences resource for knowledge, best practices, and as an educational hub. It’s not just about information dissemination; PDA is shaping an environment that pulses innovative ideas, practical workshops, and interactive events. It’s an environment committed to nurturing industry professionals and empowering them with the tools and knowledge they need to excel in the dynamic world of life sciences.

Extending the Reach: PDA’s Global Impact

Tavares transitioned the conversation toward PDA’s broader role, underlining its significant local and global influence. “PDA is instrumental in shaping the biotech and pharmaceutical sectors, helping startups navigate regulations, and aiding established companies in maintaining quality,” she said. PDA’s progressive approach was highlighted by its partnership with Innerspace a virtual reality company. This collaboration shows PDA’s ambition to lead and adapt to technological advancements. “We’re integrating technologies like VR to offer immersive training experiences,” Tavares confirmed.

PDA’s global impact is significant, influencing both local startups and multinational corporations. “PDA is a driving force in the biotech and pharmaceutical sectors, affecting every facet of these industries,” Tavares explained. ‘The integration of VR technology in our training programs demonstrates our mission to lead the ever-evolving industry landscape,’ Tavares said. PDA’s role in shaping the industry is indeed compelling, affecting local startups to multinational corporations. Their efforts, from guiding startups through regulations to supporting established companies in maintaining quality, underscore their vital role in the life sciences industry. The proactive integration of technologies like VR for immersive training signifies PDA’s commitment to innovation, while their emphasis on quality and innovation highlights their drive to uphold industry standards.

Overall, Tavares depicted PDA as a transformative force in the life sciences industry, guiding its current state and paving the way toward its future.

Fostering Future Leaders: Supporting Early-Career Professionals and Students

During our conversation, one theme consistently stood out: PDA’s dedication to fostering the next wave of pharmaceutical manufacturing professionals. Tavares spoke earnestly about the organization’s commitment to nurturing these newcomers, “We are firmly committed to providing an environment that encourages growth and learning for these emerging talents. After all, they are the future torchbearers of the pharmaceutical manufacturing industry.”

PDA’s support for this group goes beyond mere words. The organization backs its pledge with concrete actions. “Last year, we were successful in raising over twelve thousand dollars through various initiatives,” Tavares shared with evident pride, “This enabled us to sponsor the attendance of five students at the PDA annual meeting – a significant step in their professional journey.”

Recognizing the importance of making complex technical knowledge accessible to young professionals, PDA recently rolled out a novel initiative – a book club. “Our book club is a dedicated platform to simplify and break down complex technical reports,” Tavares explained. “This way, we facilitate smoother knowledge transitions for our younger members, aiding their understanding and increasing their competency in the industry.”

These earnest efforts to promote the growth and learning of the next generation of professionals underline PDA’s commitment to ensuring the future of the pharmaceutical industry is bright, well-educated, and well-prepared.

Engaging the Broader Ecosystem: PDA and the Business Community

As our discussion ventured into PDA’s relations with the broader business environment, Tavares highlighted the key role of its collaborations. “The active participation of the business community, from event sponsorships to equipment donations for our training institute, substantially enhances our capacity to execute our mission,” she stressed.

Tavares particularly underscored the importance of financial support. “The contributions we receive facilitate a diverse array of workshops and unique events like the Technical Report Live series. These are pivotal in disseminating industry-specific knowledge,” she expanded.

In addition to funding, Tavares pointed out the value of in-kind donations, especially for PDA’s training institute. “These donations allow us to provide practical, hands-on training experiences. Our ability to deliver such training is significantly amplified by the generosity of our business partners.”

The partnership with the virtual reality company, a testament to PDA’s commitment to technological advancements, was also highlighted. “Incorporating virtual reality into our training enriches the learning experiences of our members. Partnerships like these keep us on the leading edge,” she affirmed.

Moreover, Tavares touched on the involvement of the business community in PDA’s governance. “We have business community representatives on our board. Their insights help guide our strategic decisions, ensuring we’re aligned with the broader business environment.”

In summary, the interplay between PDA and the wider business community enhances PDA’s operations. As Tavares concluded, “Their contributions significantly boost our mission fulfillment, bringing diverse resources that enable us to innovate, educate, and effectively shape the future of the pharmaceutical industry.”

Navigating the Regulatory Landscape: PDA-FDA Joint Regulatory Conference and Deviations Workshop

Our conversation gravitated toward PDA’s unique initiatives, specifically the PDA-FDA Joint Regulatory Conference. Tavares detailed how this event, a key feature on the industry’s calendar, offers an unparalleled opportunity for professionals to engage in direct dialogue with FDA regulators. She expressed that these interactions foster an enriched understanding of compliance and regulatory specifics, crucial in the complex biotech and pharmaceutical landscape.

As we delved deeper into the specific programs and workshops PDA conducts, Tavares highlighted the significance of the Mastering Deviations workshop. She explained, “Regulatory compliance isn’t straightforward, and managing deviations effectively is a critical aspect of it. Our workshop, designed with this in mind, guides attendees in creating well-structured and informative deviation reports.”

In addition to these practical skill-building elements, Tavares emphasized PDA’s broader commitment to fostering open dialogue between industry professionals and regulatory bodies. She pointed out that initiatives like the PDA-FDA Joint Regulatory Conference are indicative of PDA’s commitment to fostering understanding and facilitating conversation, thus helping industry professionals navigate the complexities of the regulatory landscape more effectively.

Discussing the PDA-FDA Joint Regulatory Conference with Tavares, I was struck by the unique opportunity it offers for direct interaction with regulators. This event aids in understanding compliance, crucial for navigating the complex biotech and pharmaceutical industry. Similarly, the importance of the Mastering Deviations workshop was clear, as it provides attendees and their organizations with tools and strategies to help manage deviations—an essential aspect of regulatory compliance.

Tavares’ comments underscored PDA’s commitment to fostering dialogue between professionals and regulatory bodies, and it’s clear that this collaborative approach aids the industry in achieving its mission. My conversation with Tavares affirmed the significant role of PDA in promoting a culture of compliance and excellence in the pharmaceutical industry.

In summary, our discussion spotlighted the vital role PDA plays in promoting a culture of compliance and excellence in the biotech and pharmaceutical industries. Through its unique collaborations and proactive approach to addressing industry challenges, PDA is shaping a future where regulatory compliance is understood and embraced across the industry.

A Catalyst for Change

Reflecting on my conversation with Tavares, her unwavering dedication and passion for PDA’s mission became unmistakably clear. Her enthusiasm for the work in driving innovation, fostering community, and building educational platforms was indeed inspiring.

If you want to meet Tita and other leaders from PDA and the broader ecosystem make sure you stop by the Whiskey A Go Go networking event. Send an email to Greg Paetow or Tita Tavares if you’re interested in being a sponsor for the event as there are a few spots left. PQE Group (the lead sponsor for this event) is a long-time supporter of the PDA FDA Joint Regulatory Conference – for more than 10 years, it has been a priority meeting for us and one in which we always participate. The conference is very important for the life sciences industry and also provides a great opportunity to reconnect with peers and clients. We look forward to seeing PDA FDA attendees at our booth, and at the PDA Capitol Chapter Whiskey A Go-Go event on Tuesday night!” said Thomas Carganico, Vice President, VP Strategic Development, Marketing & Communications; Local Equity Partner, PQE Group.

Under the leadership of individuals like Tita Tavares, PDA has emerged not just as a participant, but as a catalyst in the pharmaceutical industry. By educating and empowering professionals, nurturing future leaders, and driving technological integration, PDA continues to redefine the contours of the industry. The insights gleaned from this discussion have underscored the significance of PDA’s role and left me with a sense of anticipation for the innovative strides the organization will take in the future.