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The Hero of Manufacturing Contamination Control -- The Microbiology Lab

Date: 25-Sep-12 to 25-Sep-12
Location: OnlineWebinar / California / United States
Category: Healthcare & Pharmaceuticals Conferences & Trade Fairs

This webinar on Contamination Control will discuss, how the micro lab can be more effectively utilized to prevent or head off microbial contamination issues as well as effectively resolve problems like recurring micro failures, investigations, and ineffective CAPAs.
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.
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

Visitors

QA managers and personnel involved in investigations of excursions and preparing CAPAs
QC managers and personnel involved in sampling, testing, and trending chem and micro data from water systems
Utility operators and their managers involved in maintaining and sanitizing water systems
Validation managers and personnel
QA managers and Regulatory Affairs personnel involved in defending water system operations and quality data to FDA and EMEA inspectors and outside auditors
Consultants and Troubleshooters

Exhibitors

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Keeping things simple and straight forward , so that we all can indeed improve the quality of our processes, our work, our businesses and enhance compliance globally.
Being inclusive, giving the process experts ( & novices! ), compliance professionals, quality champions, and regulatory agencies a voice so that all of us can contribute and make a difference.

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