Contamination Control Strategies for Sterile and Non-Sterile Operations

Venue: Doubletree Hotel, Jersey City

Location: Jersey City, New Jersey, United States

Event Date/Time: May 27, 2010 End Date/Time: May 27, 2010
Registration Date: May 26, 2010
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This one full day Comprehensive training will address the following topics:
Sources and quantities of microbial contamination
Using the QSIT approach assess microbiological contamination and their sources
Objectionable microorganisms – what they may be for your product
Facility design issues that may introduce contamination
Personnel and Material flows
Personnel hygiene and behavior
Gowning materials and gowning procedures
Facility, parts and equipment cleaning, storage and assurance of cleaning
Discussion on critical systems where microbial contamination may affect product quality
Confirming the validity of microbial contamination
Identifying the risks and liabilities
Administrative Controls for Investigating Microbial Contaminations
Systems to investigate when microbial contamination occurs
Establishing an investigation plan
Identifying areas to investigate
Data review
Summarizing findings
Determine the Assignable Cause: Systems to inspect for tracking the contamination to the source
Developing a Corrective Action Plan Recommendations
Points to Consider while compiling the Investigation Report


Doubletree Hotel-Jersey City 455 Washington Boulevard Jersey City, NJ 07310
Jersey City
New Jersey
United States