Open App
9 hours
Embassy Suites by Hilton Raleigh Durham Research Triangle
Starting at USD 25
Wed, 28 May, 2025 at 08:00 am to 05:00 pm (GMT-04:00)
Embassy Suites By Hilton Raleigh Durham Research Triangle
201 Harrison Oaks Boulevard, Cary, United States
The Parenteral Drug Association (PDA) Southeast Chapter is hosting a one-day, interactive conference curated to address critical challenges in pharmaceutical QC Microbiology. This special event combines presentations from industry experts and corresponding workshops, providing training and guidance on:
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!
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
MANY THANKS TO OUR CHAPTER SPONSORS!!
Info: Renee Shaw is a Quality Control Microbiology Manager with Sumitomo Pharma America. Her experience includes extensive knowledge in environmental monitoring, microbiology, and sterility assurance within sterile injectable product manufacturing and cell/tissue therapy manufacturing.
Previously she has acted as a Sterility Assurance Specialist with Merck, Process Area Specialist (EM) with Novo Nordisk, and Quality Control Specialist with Cellectis Biologics. Renee has her BS in Biology from Elon University
Info: Lindsey Colvin is an Executive Director of Sterility Assurance at Eli Lilly. In this role, she supports Eli Lilly’s global parenteral manufacturing operations. Lindsey provides oversite for environmental monitoring, contamination control strategy, contamination control strategy metrics, aseptic training, and cleaning validation. Lindsey has also previously worked at Bristol Myers Squibb, Merck, and Pfizer where she held various positions ranging from quality to manufacturing shop floor. Lindsey previously presented at 2020 PDA Annual Microbiology Conference, and she was recently selected as a team member for the development of the new PDA Material Transfer TR. Lindsey holds a bachelor's degree in Biological Sciences and a bachelor’s degree in Chemistry from North Carolina State University.
Info: Dave Shields is Director, Applied Microbiology at STERIS. He has been with STERIS for 15 years and has over 20 years of professional microbiology experience, including Disinfectant Efficacy Testing, Reusable Medical Device Cleaning and Disinfection Validation, Microbial Limits, Antimicrobial Efficacy, Biological Indicator Testing, and a variety of microbiological food testing. Dave is a frequent author of articles for the aseptic manufacturing industry, has presented many webinars to industry on Disinfectant Efficacy Testing, and currently sits on the BSI CH 216 Chemical Disinfectants and Antiseptics Committee, developing standards for disinfectant registration in the European region.
Info: Paula Peacos brings over 30 years of practical industry experience as a Microbiologist and possesses extensive experience in aseptic processing, biological API/drug
substance manufacturing, cell and gene therapies and nonsterile production, both
clinical and commercial, as well as microbiological laboratory management.
She has also conducted numerous compliance audits internationally as a
microbiological subject matter expert. She is an experienced trainer and has developed
and implemented creative, customized developmental and remedial programs both in
the US and abroad.
In recent years, Paula has published a number of articles, conducted technical
webinars and presented at major industry meetings on topics such as data integrity,
using contamination rates for trending analysis, designing and implementing robust
environmental monitoring and trending programs and performing successful root cause
analyses, among others.
Info: Allison Scott has evaluated and supported bio-fluorescent particle counting rapid
microbial technologies for air and water applications for over fifteen years. As part of
this work, she is an active member and facilitator of the Modern Microbial Methods (M 3 )
Collaboration, a group of industry experts dedicated to advancing the knowledge,
adoption, and implementation of modern microbial technologies. Allison serves as a
Principal Scientist at BWT Pharma & Biotech Inc., where she specializes in online water
bioburden analyzers, and is also a member of the United States Pharmacopeia (USP)
Microbiology Expert Committee.
Info: At registration, select three workshops led by subject matter experts to enhance your training.
Info: At registration, select three workshops led by subject matter experts to enhance your training.
Info: At registration, select three workshops led by subject matter experts to enhance your training.
Also check out other Workshops in Cary, Business events in Cary, Conferences in Cary.
Tickets for Mastering Challenges in Pharmaceutical QC Microbiology can be booked here.
| Ticket type | Ticket price |
|---|---|
| PDA Member Registration | 250 USD |
| PDA Non-Member Registration | 275 USD |
| Student Registration | 25 USD |
| Exhibitor Table with Registration for 1 | 750 USD |
| Exhibitor Table- Extra Admission only | 125 USD |
We have gathered all the information for you in one convenient spot, but please keep in mind that these are subject to change.We do our best to keep everything updated, but something might be out of sync. For the latest updates, always check the official event details by clicking the "Find Tickets" button.
