Controlling Microbial Contamination to Assure Product Quality, Patient Safety and Regulatory Satisfaction
Paul Sturman, PhD, Industrial Coordinator, Center for Biofilm Engineering, Montana State University-Bozeman
Kalavati Suvarna, PhD, Microbiologist, DMPQ, CDER, FDA
Biologic product sterility assurance is a critical quality attribute for parenteral products and certain medical devices and can only be achieved through strong aseptic manufacturing processes and control. Aseptic manufacturing microbial control is also important for many non-sterile products as well. The 2014 PDA Bioburden and Biofilm Workshop will discuss critical issues encountered during aseptic manufacturing processes which may contribute to microbial contamination and focus on current opportunities and challenges for individuals or firms engaged in the development of new processes. Industry and regulatory perspectives presented throughout the workshop will focus on defining effective microbial control program encompassing product for processes as well as facility, equipment, utilities and personnel controls.
Best practices for remediation of contaminated processes and equipment will be reviewed with case studies where remediation was possible. The case studies will provide lessons learned in effective quality investigations and regulatory interactions once problems occur. The workshop will present practical approaches to the prevention, detection, and remediation of microbial contaminations that attendees can use in daily production and laboratory operations. The workshop will also provide attendees with a first look at the outcome of the PDA survey on Bioburden and Biofilm Management along with an update on the status of the Bioburden and Biofilm Management technical report.
Upon completion of this workshop, you will be able to:
- Convey the principles and best practices of microbial control in pharmaceutical processes based on current best practices and regulatory expectations
- Provide a practical scientific understanding of the biology underlying bioburden development in pharmaceutical and biopharmaceutical drug substance production systems.
- Explain the mechanisms surrounding biofilm formation and the complex interactions between that exist between planktonic and sessile modes of microbial contamination
- Present information on typical control levels/limits for various types and stages of biopharmaceutical production systems, including critical utility systems
- Develop an understanding of the principles and best practices in prevention, detection, and remediation of microbial contamination in pharmaceutical/biopharmaceutical drug substance or API production systems, including current regulatory guidance and expectations
- Manage microbial quality issues and conduct effective investigations, remediation, and regulatory interactions
Who Should Attend
Microbiology, Compliance, Engineering, Manufacturing, QA/QC, Development, Regulatory Affairs, Research and Development, Validation
Level of Expertise
Executives, Management, Scientists/Technicians