- 4:30-5:30 Rapid Micro Biosystems Tour
- 5:30-6:30 Sponsors/Networking Hour
- 6:30-7:00 Dinner
- 7:00-9:00 Presentations
To Stress or Not to Stress
There is a lot of debate around the importance of using stressed microorganisms as part of microbial test method validations, with arguments for and against the use of stressed microorganisms. You can also find arguments on the appropriate type of stress method. What is the right answer? This presentation will provide guidance to answer that question through the evaluation of stress methods, the impact stress has on delay in microbial recovery, and use for environmental monitoring methods.
The presentation will focus on the following objectives:
- List of common microorganisms found in the pharmaceutical manufacturing environments.
- A minimum of two microorganism stress methods
- Time-to-Result (TTR) analysis for stressed and non-stressed microorganisms commonly recovered in pharmaceutical manufacturing environments .
- Potential incubation temperatures and duration options for common microorganisms found in the pharmaceutical manufacturing environment that can be used to facilitate recovery from stress.
Owen has 12+ years of experience working in and leading laboratories for pharmaceutical companies, contract development and manufacturing organizations (CDMO), and contract research organizations (CRO). During his career he has worked in both sterile and non-sterile GMP facilities leading teams that support API, excipient, and drug product manufacturing activities. Over his career he has developed environmental monitoring programs, implemented contamination control strategies, designed microbial method validations, and led global initiatives as a Microbiology subject matter expert (SME).
Owen earned a B.S. in Microbiology and Laboratory Technology from Auburn University. Owen is currently the Director, R&D Microbiology at Rapid Micro Biosystems. In this role his team is responsible for new product development activities and customer applications support.
Data Integrity as an Indicator of Other Quality Control Issues
Data Integrity Issues: Implications on other Quality Control Process Issues?
Due to numerous and severe regulatory findings, companies have all boarded the Data Integrity train and started remediating their automated systems, developing checklists, process flowcharts and risk registers. But what if Data Integrity is not the real problem, but a result of another issue? This presentation will share experiences from a site where this was the situation – data integrity was the symptom of deeper issues. The presentation will share facts observed and how those facts came together to reveal the root issue—an issue likely shared at many companies. How do Process Engineering, Sales and Marketing, Analytical Development and Process Development create Data Integrity issues in the QC Laboratory? This presentation wants you to you re-think what you know about Data Integrity remediation.
- Member, ISPE and GAMP Community of Practice (CoP)
- Member, Parenteral Drug Association. Committee member for 2021 Data Integrity Conference
- Chair, ISPE Global Documents Committee (2017-2019); currently committee member
- Co-Lead, ISPE/GAMP Data Integrity Special Interest Group (Jan 2014-2021)
- Co-Lead, ISPE/GAMP Laboratory Special Interest Group (2011-2013)