Pharmaceutical Microbiology East Coast - Virtual Conference

SMi is proud to announce the 3rd Annual Pharmaceutical Microbiology East Coast Virtual Conference taking place on October 28th – 29th, 2020. .. Read more The pharmaceutical microbiology industry has seen many changes during the progression into the 21st century. With advances in rapid microbiological methods, revisions being made to regulations in the industry, enhanced knowledge of the human microbiome, and novel testing methods, innovative approaches in ATMP facilities, this industry is ever expanding.ndustry experts to discuss and analyze the latest advances and challenges within the industry. Network with industry professionals, discuss revisions in regulatory and guidance documents, explore data integrity considerations for conventional and rapid microbiology methods, analyze arising issues with environmental monitoring to best control contamination and gain insight into an industry perspective on automated endotoxin testing and process automation. Pharmaceutical Microbiology East Coast will discuss the ongoing complication of personnel derived contaminations from the FDA. Gain valuable insight towards microbiological quality considerations in non-sterile manufacturing and control of BCC from Parexel. • Introduction of the FDA’s impending guidance on this topic • Regulatory Expectations for microbial control of non-sterile drugs • Case studies of microbiological contamination of non-sterile drug products to demonstrate the impact on product quality and the manufacturing process.