2025 PCPC Science Symposium & Expo – Agenda
2025 PCPC Science Symposium & Expo – Agenda
Agenda
October 28, 2025
Networking Breakfast
Opening Remarks

Keynote Session: Eco-NAMs Exchange: A Forum for the Future of Ecotoxicity Testing
This session highlights cutting-edge research, practical applications, and emerging trends in ecotoxicity testing, with a focus on reducing reliance on traditional animal-based methods and enhancing environmental protection. Whether you're a seasoned scientist or simply curious about the future of environmental toxicology, Eco-NAMs offers a unique opportunity to engage with the science shaping tomorrow’s ecological safety standards.



Break with Exhibitors
Water System Compliance: Are You Audit Ready?
MicrobiologyWater systems are fundamental to the manufacturing of pharmaceutical and personal care products, impacting product quality, safety, and regulatory standing. Ensuring compliance with FDA guidelines and microbiological standards is essential to prevent contamination and guarantee consumer protection. This session will provide a comprehensive overview of the design, operation, and monitoring of manufacturing water systems in the context of regulatory expectations. Key topics include classification of water types (such as USP Purified Water and Water for Injection), critical system components, routine microbiological testing, and strategies for controlling and remediating biofilm formation. Practical approaches for documentation, deviation management, and responding to FDA inspections will be discussed. The session aims to support manufacturing and quality professionals in establishing robust water systems that consistently meet regulatory and microbiological compliance requirements.
Break with Exhibitors
Hygienic Failures in Automated Cleaning System: Prevention and Detection
MicrobiologyJoin us for an informative session that will examine the microbiological risks associated with Clean-in-Place (CIP) and Clean-out-of-Place (COP) systems when they are improperly designed, implemented, or maintained. Attendees will gain insights into common misconceptions and design flaws that can lead to microbial contamination and harborage. The session will also present practical strategies for identifying hygiene hazards and implementing effective controls to ensure system integrity and product safety.

Networking Lunch
Microbial Challenges of Environmental Isolates in the Cosmetic Industry
MicrobiologyMicrobial contamination remains a significant concern in the cosmetic industry, with environmental isolates posing persistent and complex challenges. Between 2011 and 2023, the U.S. FDA received over 400 adverse event reports related to cosmetics, of which 76.8% were associated with microbial contamination. Environmental isolates such as Pseudomonas species and the Burkholderia cepacia complex present particular challenges to the cosmetic industry because they are difficult to control in a manufacturing setting. The session will explore microbiological risks posed by these organisms, the regulatory landscape, and practical strategies for mitigation within cosmetic production settings.

Break with Exhibitors
Unlocking the Potential of the Microbiome
MicrobiologyJoin Dr. Samaras as she presents human studies of the skin microbiome and its transformative role in cosmetic science. This session will explore how the microbiome varies across individuals, ages, and body sites, and how recent findings link its composition to psychological wellbeing, opening new avenues for innovation. Dr. Samaras will also discuss the microbiome’s resilience to external perturbations and how these insights have guided the design of safety evaluation studies within a decision framework. Finally, the session will highlight the integration of artificial intelligence in clinical studies to further uncover host-microbiome functions, driving the future of safe and effective cosmetic solutions.

Accelerated Product Design of Safer and Eco-friendly Consumer Products through Expert Formulation Science Guided AI/Machine Learning
MicrobiologyAs consumer demand for safer, more sustainable products grows, the cosmetic and personal care industry is shifting toward bio-based alternatives like biosurfactants and biopolymers. But replacing traditional ingredients isn’t just about going green—it’s about matching or exceeding performance standards like rheology and surface activity. In this session, Dr. Amin will highlight how AI/ML based models for optimizing surfactant and polymer physico-chemical properties like rheology, surface activity etc and a smarter limited Design of Experiments (DOE) can be utilized to accelerate the product development process for complex multicomponent consumer and cosmetic formulations.

Closing Remarks & Early Career Microbiologist Award Ceremony
Microbiologists play a pivotal role in bringing innovative and safe products to market. PCPC is committed to nurturing talent and paying it forward to support the future of our industry. Join us as we celebrate the 2025 recipient of the Early Career Microbiologist Award and hear closing remarks from PCPC Microbiology Committee chair, Dennis Neeson.

Reception
October 28, 2025
Networking Breakfast
Opening Remarks

Keynote Session: Eco-NAMs Exchange: A Forum for the Future of Ecotoxicity Testing
This session highlights cutting-edge research, practical applications, and emerging trends in ecotoxicity testing, with a focus on reducing reliance on traditional animal-based methods and enhancing environmental protection. Whether you're a seasoned scientist or simply curious about the future of environmental toxicology, Eco-NAMs offers a unique opportunity to engage with the science shaping tomorrow’s ecological safety standards.



Break with Exhibitors
Environmental Risk Assessment (ERA) 101
Environmental ScienceEnvironmental risk assessment (ERA) is used to understand the potential risk to organisms (e.g., fish, birds, etc.) posed by chemicals released into the environment. This presentation will discuss the importance of the volume/mass of chemicals and ingredients released, pathways into the environment, prediction of environmental concentrations (e.g., soil, water), and concentrations which could have negative effects on organisms in the environment.

Break with Exhibitors
Impact of Personal Care Products in the Environment: Focus on Wastewater Treatment Processes and Wastewater Permitting
Environmental SciencePersonal care products (PCPs) have dramatically increased over the last several decades and will continue to do so. Because of their increased use, PCPs have been found in wastewater, which is discharged to the environment. Surveys in the US and globally have detected PCPs in surface water, however, the mere presence does not specifically indicate harm, because most of these concentrations are below environmentally relevant levels. While PCPs may occur in soil and air, this presentation focuses on aquatic environments, as discharges to surface water are the most common pathways for PCPs to enter the environment and the associated wastewater treatment processes. Removal of PCPs by conventional wastewater treatment technology varies broadly from low (<50% removal) to high (>80% removal). Advanced wastewater treatment such as membrane biological reactor (MBR) and sequencing batch reactor (SBR), often using additional technologies such as oxidation and ultrafiltration or nanofiltration systems, are much more efficient at degrading PCPs due to using both aerobic and anaerobic conditions. Removal rates of these advanced treatment strategies have been reported at 90% to above 95%. In addition to discussing wastewater treatment processes, this presentation will also discuss wastewater permitting, such as NPDES permitting and/or pretreatment requirements, with specific consideration to PCPs.

Networking Lunch
Scientific Issues Associated with Use of QACs in Personal Care Products
Environmental ScienceQuaternary ammonium compounds (QACs) are widely used antimicrobial agents in personal care products, disinfectants, and cosmetics. This session will examine the environmental fate, toxicity mechanisms, and ecological and health impacts of QACs released from personal care products into aquatic, residential, and terrestrial environments. Special attention will be drawn to the evaluation of data quality and its suitability for risk assessment and regulatory decision-making.
Break with Exhibitors
Characterization and Detection of Microplastic in Consumer Products and the Environment
Environmental SciencePlastic is a huge part of the global consumer product market today. Microplastics can come from the breakdown of the consumer products themselves or can be added intentionally to endow other properties to the products. Consumers are becoming more wary of the impacts of microplastics on the environment and on their health. In this presentation, Dr. Cowger will cover the current scientific knowledge about microplastics from consumer products, current and proposed policies, best practices in product development, and techniques for monitoring and tracking progress in reducing microplastic release from consumer products.

Communicating Science and Risk: Lessons from Chemical Risk Evaluation and Management under TSCA
Environmental ScienceEffective science and risk communication is critical to building trust, enhancing regulatory understanding, and supporting informed decision-making in chemical policy. Under the Toxic Substances Control Act (TSCA), chemical risk evaluation and management involve complex scientific analyses, nuanced regulatory frameworks, and a wide range of stakeholder perspectives—from government agencies and industry to NGOs and the public.
In this session, Dr. Hartigan will explore the importance of transparent, accurate, and audience-tailored communication in the TSCA context. Through real-world case examples from recent risk evaluations and management actions, it will highlight common communication challenges and showcase strategies for translating technical findings into clear, credible, and constructive messages. Attendees will gain insights into how effective communication can reduce confusion, foster trust, and support meaningful engagement across diverse audiences.
This presentation will examine the importance of transparent, accurate, and audience-appropriate communication. Using case examples from recent risk evaluations and management actions under TSCA, it will highlight both challenges and opportunities in translating technical findings for expert and non-expert stakeholders. The discussion will offer insights for conveying complex science in ways that are clear, credible, and constructive, supporting more informed engagement across regulators, industry, and the broader public.

Environmental Science Program Closing Remarks

Reception
October 29, 2025
Networking Breakfast
Opening Remarks

Keynote Session: MoCRA Compliance in Action: Adverse Event Reporting, Recordkeeping and Risk Management
This session will provide an up-to-date overview of MoCRA implementation, highlighting key regulatory milestones and evolving FDA guidance. It will unpack adverse event reporting and recordkeeping requirements, offering best practices for compliance, documentation, and data analysis. Attendees will gain practical insights into aligning procedures with MoCRA’s expanded oversight and enforcement provisions.



Break with Exhibitors
Toxicology Hot Topics - The New Era of Safety
SafetyDr. Danielle Wikoff is at the forefront of applying evidence-based toxicology to cosmetic safety, using systematic reviews and AI-assisted methods to assess ingredient risks across diverse data streams. Her work emphasizes transparency in evaluating data quality and uncertainty, helping regulators and industry stakeholders make informed decisions about cosmetic formulations and consumer health. Dr. Wikoff will share her insights on food dye regulation, environmental safety assessment, and implementing NAMs in regulatory decision making.

Break with Exhibitors
Precision in Practice: Modeling Real-World Exposure to Cosmetics
SafetyDr. Benjamin Smith of the Monell Chemical Senses Center and Anne Marie Api of RIFM will presenting cutting-edge approaches to exposure assessment for cosmetic ingredients and products, highlighting the role of consumer use patterns and quantitative modeling. Their presentation will detail the integration of real-world exposure data with toxicological thresholds to improve safety evaluations and regulatory confidence.

Networking Lunch
Rooted in Science: Best Practices for Botanical Safety Assessment
SafetyConnie Mitchell, through the HESI Botanical Safety Consortium, is driving collaborative research to develop science-based methods for evaluating botanical ingredient safety, with a focus on advancing in vitro and in silico tools. Anne Marie Api of RIFM leads efforts to assess fragrance ingredients, including botanicals, using robust safety frameworks that integrate exposure modeling and toxicological data. Bart Heldreth of the Cosmetic Ingredient Review, champions transparent, expert-driven evaluations of botanical ingredients in cosmetics to ensure consumer safety and regulatory compliance. Together they will guide us through the current best practices of botanical safety assessment and provide insight on future directions.

Break with Exhibitors
Considerations for Clinical Studies of Cosmetics
SafetyDr. Neena Tierney, Global Head of Translational Science R&D at Kenvue, will share how clinical testing of cosmetics translates cutting-edge skincare science into effective solutions for consumers. Her work spans in vitro and clinical research, focusing on rigorous study design, claims substantiation, and ethical clinical testing practices across major global brands like Neutrogena and Aveeno.

Bridging Beauty and Safety: The Role of Science and Risk Communication in Cosmetics
SafetyCompanies are increasingly having to defend their products and their scientific research against attacks from activists and influencers, which can quickly escalate into reputational and trust crises. As Andy Grove, former CEO of Intel, once said, “Bad companies are destroyed by crisis. Good companies survive them. Great companies are improved by them.” This interactive panel explores best practices for companies and their scientific teams to strengthen credibility, protect their science and emerge stronger in the face of public scrutiny.




Safety Program Closing Remarks

October 29, 2025
Networking Breakfast
Opening Remarks

Keynote Session: MoCRA Compliance in Action: Adverse Event Reporting, Recordkeeping and Risk Management
This session will provide an up-to-date overview of MoCRA implementation, highlighting key regulatory milestones and evolving FDA guidance. It will unpack adverse event reporting and recordkeeping requirements, offering best practices for compliance, documentation, and data analysis. Attendees will gain practical insights into aligning procedures with MoCRA’s expanded oversight and enforcement provisions.



Break with Exhibitors
Engagement through Quality Agreements
QualityBreak with Exhibitors
Artificial Intelligence: The New Frontier
QualityArtificial Intelligence (AI) is transforming quality operations by enhancing accuracy, consistency, speed, and decision-making. But the next generation of AI goes beyond task support—it collaborates. Agentic AI systems function like high-level strategists: identifying emerging risks before they surface, bridging gaps across regulatory, consumer, and R&D silos, and retaining context to evolve with your organization. This presentation will explore the current AI landscape, while the afternoon session will dive into a real-world case study to illustrate its practical application.

Networking Lunch
MoCRA: The Path Forward
QualityTom Cosgrove and Jessica O’Connell, Covington partners in the firm’s Food, Drug, and Device Practice Group will reflect on the current landscape shaped by emerging FDA regulations and shifting compliance expectations. Bring your questions for an engaging and informal conversation with the experts.
Break with Exhibitors
Practical Approaches to Cleaning and Validation
QualityVeteran quality leaders will engage in a discussion on the topic of Cleaning Validation. Through the voice of practical experience, you’ll gain insight on what the current thinking is on residue testing, the most useful cleaning agents and methods for specific applications and equipment, how to manage hard-to-clean areas, best practices for routine verification activities, different approaches for cosmetic vs. OTC lines, and more.






Artificial Intelligence as a Quality Tool
QualityAI predicts. It doesn’t understand. In this session, you’ll learn how to spot hidden risks in AI outputs and apply the Truth Spiral™, a simple tool to question results and strengthen critical thinking. We’ll also show how AI can support real-world quality tasks like recall scanning and data hygiene, giving you practical takeaways you can use right away.

Quality Program Closing Remarks
