PDA Southeast Chapter: Spring Conference Mastering Challenges in Pharma QC Microbiology

Join industry experts for a one-day, immersive conference focused on overcoming key challenges in pharmaceutical QC microbiology. This event combines in-depth discussions with hands-on workshops, providing practical insights and regulatory perspectives on:

• Alternative/rapid test method validation
• Effective microbial deviation investigations
• Environmental Monitoring Performance Qualification (EMPQ)
• Cleaning validation & disinfectant efficacy
• Setting environmental monitoring (EM) alert & action levels

Designed for microbiologists, QC laboratory professionals, quality practitioners, and regulatory specialists, this conference offers a unique opportunity to gain actionable knowledge, engage in interactive discussions, and refine laboratory practices to meet evolving industry standards.

During the breaks and lunch, meet with local exhibitors who will bring the industry's latest products, technologies, and services that could help transform your work.

Designed for microbiologists, QC lab professionals, quality practitioners, and regulatory specialists, this conference offers a unique opportunity to bring something actionable back to your team!

We look forward to welcoming you to what promises to be an enlightening and impactful day of professional development!

WORKSHOPS:

EMPQ Design Challenge:

This workshop immerses participants in the process of designing an Environmental Monitoring Performance Qualification (EMPQ) for a cleanroom environment. Attendees will work through a risk-based EMPQ example, incorporating site selection, sampling methods, incubation protocols, and data analysis approaches.

Microbial Investigation Mini-class:

This workshop uses an analogy to guide participants through the critical steps of a microbial data deviation investigation, from initial detection to root cause analysis and corrective and preventive actions (CAPA). Through guided exercises, attendees will assess environmental monitoring data, identify potential contamination sources, and apply risk-based decision-making to resolve deviations. Key topics will include microbial identification, contamination trend analysis, investigative techniques, and best practices for documentation and reporting.

Devising a Disinfection Efficacy Strategy:

In this workshop, participants will engage in a hands-on design challenge to develop an effective disinfection efficacy strategy for pharmaceutical cleanrooms. Attendees will assess materials of construction, microbial risks, select appropriate disinfectants, and start to design a validation study that meets regulatory requirements. Participants will determine challenge organisms, contact times, rotation strategies, and methods for evaluating efficacy.

Practical EM Alert and Action Limits Determination:

This workshop will have participants will engaging in a hands-on exercise to establish risk-based limits based on regulatory expectations, historical data, and contamination risk factors. Attendees analyze environmental monitoring data to identify trends, justify limits, and ensure compliance. Discussion points may include statistical approaches, microbial recovery rates, and responding to excursions.

Validating and Implementing Rapid Microbial Methods:

This workshop guides participants through the key steps of validating and implementing an alternative/rapid microbiological method (ARMM) in a pharmaceutical setting. Attendees will work an example to develop a validation strategy, including method selection, risk assessment, equivalency testing, and regulatory considerations. Participants will also explore the practical challenge of integrating rapid methods into existing QC workflows, including training, documentation, and change control