Feb 16-17 2006 — Crowne Plaza, Foster City, San Francisco Area
http://www.microrite.com/Investigating_Microbial_Contaminations_San_Francisco_February_2006.pdf
March 23-24 2006– Caribe Hilton, San Juan, Puerto Rico
http://www.microrite.com/Investigating_Microbial_Contaminations_Puerto_Rico_March_2006.pdf
January 18, 2006 — /MEDICAL INDUSTRY E-MAIL NEWS SERVICE(TM)/ — RAMSEY, N.J. — Microrite Inc released today its schedule of upcoming microbial contamination seminars.
DAY 1
Investigation Strategies & Investigating Media Fill Failures
<>Discussion on critical systems where microbial contamination may affect product quality
<>Confirming the validity of contamination
<>Identifying risks & liabilities
<>Administrative controls for investigating microbial contaminations
<>Systems to investigate when microbial contamination occurs
— Establishing an investigation plan
— Identifying areas to investigate
— Data review
— Interviews
— Summarizing findings
<>Determine the assignable cause: systems to inspect for tracking contamination to the source
<>Developing corrective action plan recommendations
<>Points to consider while compiling the investigation report
<>Discussion on aseptic media fills & sterility testing
— Similarities & differences between the 2
<>Discussion on validation of aseptic processing guidance for industry
<>Elements of investigation for failed media fill runs
— Facility
— Equipment
— Personnel
— Training
<>Addressing unusual events during media fills
<>Consequences of contamination during media fills
DAY 2
<>Investigating environmental monitoring excursions & equipment cleaning & sterilization
— What is an environmental monitoring excursion?
— What do you do when you find an EM excursion? (step-by-step)
— What safety issues need to be addressed when you find an excursion?
— How is an investigation for an EM excursion conducted?
— What type of information do you need to collect during your investigation?
— How people misuse of information from microbiology text books.
— How much information do you need to make decisions with?
— What are corrective actions & how do you know that they worked for sure?
— When is it appropriate to use EM data as a product release criterion?
— What type of investigational approach is used for media fill failures?
— What type of investigational approach is used for sterile batch failures?
— What expectations do FDA officials have regarding failure investigations for sterile products?
<>Discussion on cleaning kinetics issues during investigations of equipment contamination
— What is going on during the cleaning process
— Is the equipment getting cleaned to remove all prior product or contamination
— Investigating equipment design flaws that can lead to contamination
<>Discussion on what to look in equipment design when investigating product contamination
— Points to consider while choosing equipment & parts from a contamination control perspective
— Definition of a CIP Cycle – What is each step for?
— Understanding & developing CIP cycles to avoid contamination
— Investigating appropriateness of CIP Cycles as a part of a contamination investigation
— CIP skid components – what to look for in the plant
— Step by step investigating components of the CIP skid to ensure that CIP cycles are effective
<>Types of bioburden reduction:
<>Sanitary vs sterile
<>Steam-In-Place (SIP)
<>Saturated steam conditions
— Temperature/pressure relationship
— Function of steam traps
<>Autoclaves, Vessels, Filters & Transfer Lines
— Autoclaves (Vacuum vs Nonvacuum)
— Empty vessel SIP
— Full vessel SIP
— Sterile envelope boundary
<>Proper Use of Tempilstik
<>Post-Contamination Procedure
— Be prepared
— Immediate actions following a contamination investigation
— Step by step investigation
<>Findings
— What to conclude from your findings
— False positive?
<>Contamination Prevention
— Preventive Steps
— Good equipment design
— Design flaws (Avoid at all cost)
ACCOMMODATIONS:
Limited sleeping rooms are available at reduced rates for both hotels.
FOR FURTHER INFORMATION, PLEASE CONTACT:
Ziva Abraham
Microrite Inc
5019 New Trier Ave
San Jose CA USA 95136
408-445-0507 phone
408-445-1236 fax
[email protected]