Sponsor or Organizer: Benastrum

Description: Biofilm contamination and control continues to create concerns in the manufacturing of biological, biotech and pharmaceutical products. Facing regulatory compliance issues, sterile manufacturing processes often experience intense regulatory focus. Several microbiological investigations have been cited in FDA Warning letters as a result of being unable to identify the "root cause" of contamination, which has resulted in significant regulatory and financial impact on a company's ability to license new products. In some of these cases, biofilm formation and contamination may have been the cause.

During this live and interactive web seminar, Dr. Frank S. Kohn will look at the main microbiological issues cited by the FDA in manufacturing, primarily biofilm formation and contamination, cross-contamination, risk assessment, prevention and control. Various approaches for the removal of biofilm will also be reviewed, including mechanical, biocide and sterilization techniques. Insight and experience from biofilm case studies will be discussed, providing a comprehensive approach to the prevention and control of biofilm found in biological and pharmaceutical products.

Dates: 04/08/2008

Location: Online, IA, USA