In recent years Mold Contaminations and Recalls have been a focus of attention for the FDA. The wave of mold related inspections and recalls are in response to a deadly fungal meningitis outbreak linked to contaminated steroids from a now infamous compounding pharmacy and a wave of high profile recalls. A risk-based approach to mold is required in order to prevent a catastrophic outcome.
There is no one solution for preventing, controlling and remediating mold contaminations. The same mold may be detrimental in one product but may have no clinical implication in another. Understanding mold, its proliferation methods and its clinical relevance is the solution. The key is not to panic at the first sight of mold.
Environmental monitoring programs which are not risk based rarely track mold thus prevention cannot be practiced. Disinfection is misunderstood in relation to mold proliferation, hence disinfection programs may not kill mold and conducting efficacy studies does not provide holistic solutions. Many times facility design, maintenance and airflow patterns are not adequate and mold may spread within the cleanroom or barrier system due to these deficiencies. A product passing <USP> antimicrobial efficacy test does not guarantee that no mold will grow in the product as preservatives/antimicrobials are tested against easy to control mold.
While non-sterile production facilities do not require stringent environmental controls, many mold species are still detrimental in
certain non-sterile products.
Mold proliferation, prevention and control are not understood because there is a gap in mycological expertise within the pharmaceutical industry. Microrite invites you to attend this never before offered intensive workshop.
This course is taught by a mycologist with over 25 years of experience in mold contamination investigations.