Why Should You Attend:
The Microbiology Lab must take leadership in contamination control support for production because it is the hub of the necessary technical expertise. This broad manufacturing support role covers many areas, including routine raw material and product testing, disinfectant/sanitant qualification, water and compressed gas testing, environmental monitoring, microbiological “awareness training” of production operators, etc. Perhaps their most difficult leadership role is in contamination control investigations where product is at risk, manufacturing may be at a standstill, and the pressure to resume operation with a quick (and possibly incorrect) fix is tremendous. In these situations, the microbiology lab can either gain or lose credibility in the eyes of manufacturing management depending on the timeliness of its success in discovering and resolving the problems.
This presentation will discuss these roles and how the lab can assure these activities are performed in a manner that facilitates root cause excursion investigations and avoids the lab or its personnel becoming the inadvertent cause of the excursions.
Areas Covered in the Seminar:
Why the microbiology lab must lead in contamination control.
Lab personnel have microbiological knowledge and expertise; QA usually doesn't
Lab uses tools and techniques able to assess contamination and sources
Lab uses appropriate controls to detect and prevent testing problems
Routine contamination evaluation activities.
RM and Product testing
Environmental monitoring
Water, steam, and compressed gas monitoring
Sanitizer and disinfectant evaluations
Microbiological awareness/aseptic process training for operators.
Root cause microbial contamination investigations.
Ability to interpret investigation data and microbial impact
Ability to withstand production pressure for hasty, potentially faulty conclusions
Truly understand cause(s) of problem so can derive effective CAPA
Microbiological conscience for the company
The Microbiology Lab must take leadership in contamination control support for production because it is the hub of the necessary technical expertise. This broad manufacturing support role covers many areas, including routine raw material and product testing, disinfectant/sanitant qualification, water and compressed gas testing, environmental monitoring, microbiological “awareness training” of production operators, etc. Perhaps their most difficult leadership role is in contamination control investigations where product is at risk, manufacturing may be at a standstill, and the pressure to resume operation with a quick (and possibly incorrect) fix is tremendous. In these situations, the microbiology lab can either gain or lose credibility in the eyes of manufacturing management depending on the timeliness of its success in discovering and resolving the problems.
This presentation will discuss these roles and how the lab can assure these activities are performed in a manner that facilitates root cause excursion investigations and avoids the lab or its personnel becoming the inadvertent cause of the excursions.
Areas Covered in the Seminar:
Why the microbiology lab must lead in contamination control.
Lab personnel have microbiological knowledge and expertise; QA usually doesn't
Lab uses tools and techniques able to assess contamination and sources
Lab uses appropriate controls to detect and prevent testing problems
Routine contamination evaluation activities.
RM and Product testing
Environmental monitoring
Water, steam, and compressed gas monitoring
Sanitizer and disinfectant evaluations
Microbiological awareness/aseptic process training for operators.
Root cause microbial contamination investigations.
Ability to interpret investigation data and microbial impact
Ability to withstand production pressure for hasty, potentially faulty conclusions
Truly understand cause(s) of problem so can derive effective CAPA
Microbiological conscience for the company
