Member/Nonmember Price: $75
Both the regulatory and industry pharmaceutical microbiologists are faced with keeping current with the ever changing and adapting microorganisms as they habituate to pharmaceutical products, their preservatives and production environments. Over the last several decades scientific literature, as well as industry product recalls, describe the emerging and evolving list of objectionable microorganisms. This poses a challenge for industry with developing methods that allow broad recovery of objectionable microbes, as these contaminants have spoiled drugs, biologics, and medical devices and have caused severe injury and even death to consumers. This address will explore key GMP regulations regarding objectionable organisms, describe a general frame work for defining “objectionable microorganisms” with FDA and USP resources to assist in this decision making process, and present a case study containing key elements associated with this topic.
Departments: Microbiology, Compliance, Engineering, Manufacturing, QA/QC, Development, Regulatory Affairs, Research and Development, Validation Level of Expertise: Executives, Management, Scientists / Technicians
Dennis E. Guilfoyle, PhD, Pharmaceutical Microbiologist, US Food & Drug Administration
Dr. Guilfoyle has been with the FDA for the past 38 years and has been classified as an international expert in pharmaceutical microbiology. He serves as an instructor at both national and regional FDA training courses for pharmaceutical, medical device and biotechnology inspections. Dr. Guilfoyle has testified and consulted as a government expert for the U.S. Attorney's Office on several FDA court cases (civil and criminal). He is a liaison to the USP expert committee. He also teaches cGMP and Process Validation graduate courses at St John’s University, Queens NY.
Jason E. Brown
Senior Programs Manager
Tel: +1 (301) 656-5900 ext. 131
Fax: +1 (301) 986-1093