This event has been cancelled due to inclement weather and will be rescheduled for a later date.
In recent years mold contaminations and recalls have been a focus for the FDA. This wave of mold related inspections is in response to a deadly fungal meningitis outbreak linked to contaminated steroids from a now infamous compounding pharmacy. A risk-based approach to mold is required in order to prevent a catastrophic outcome.
A specific 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.
When facility design and maintenance, risk based environmental monitoring and disinfection programs as well as airflow patterns are not adequate it is hard to track, prevent or control mold.
While non-sterile production facilities do not require stringent environmental controls, many mold species are very critical in certain non-sterile products. 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.
Which industries does this workshop apply to?
Pharmaceuticals, Biotechnology, Medical Device, and In Vitro Diagnostics, Nutraceuticals and Pharmacies
Who will benefit?
QC Microbiologists, Manufacturing, Quality Assurance, Validation, Facilities and Training
Date: September 17th-18th 2018
Location:North Carolina Biotechnology Center
Address: 15 TW Alexander Dr, Durham, NC 27703
About Microrite, Inc.
Microrite is a San Jose, CA based Consulting and Training Company helping Pharmaceuticals, Biotechnology , Medical Devices and Drug-Device Combination Products, Biofuels and In Vitro Diagnostics in the areas of Quality Assurance, Quality Control, Microbiology, Process Development, Process Validation, Facility and Utility Validation and Equipment Validation.
Controlled Contamination Services is a leading provider of facility solutions for the pharmaceutical, biotech, medical device, electronic, semiconductor, manufacturing, high tech, IT, and aerospace and defense industries. CCS provides its clients with highly specialized cleaning, bio-decontamination, as well as a wide array of technical service solutions that exceed the health, safety, and environmental requirements at facilities of any size and use. With more than 28 years of industry and quality knowledge and experts across the US, CCS utilizes an in-depth understanding of FDA regulations and GxP requirements to meet and exceed the most stringent cleaning and decontamination needs. Whether your site is a multi-million square foot facility or a more modest project, CCS is your choice to deliver the highest quality solutions for your environment.
CCS’s Data Center Services Division provides a wide range of specialty cleaning services that included: Data Center Cleaning, Hot Aisle, and Cold Aisle Containment Systems, Water and Leak Detection, Facility Monitoring, Computer Room Cleaning, Post Construction Cleaning, Underfloor Plenum Cleaning, Raised Floor Access Cleaning, Equipment, and Environment Cleaning, Zinc Whisker Testing and Remediation, 7 X 24 Disaster Recovery Services. CCS also offers High-Efficiency Infrastructure Optimization products and services for data center customers who are in need of improved infrastructure cooling, power and monitoring efficiency, and management.