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.
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
Who will benefit:
This webinar will be valuable for all companies that operate WFI or Purified Water systems, particularly for those in FDA and EMEA regulated industries, including Medical Devices, Diagnostics, Pharmaceuticals, and Biologics fields, as well as consumer products and cosmetics companies. The employees who will benefit include:
- 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
Instructor Profile:
T.C. Soli, is a Ph.D. Microbiologist and President of Soli Pharma Solutions, Inc. (www.solipharmasol.com), and since becoming a full time consultant, has served consumer products and FDA-regulated industries with training and troubleshooting expertise covering water systems, sterilization, aseptic processing, microbiological and beta-lactam contamination control, microbiological laboratory operations, and has served as a pharmaceutical expert witness in several "contamination" litigations. Prior to full time consulting, he had 25 years of diverse "Big Pharma" operating company experience.
During his 30 year career he has lectured extensively at conferences, authored numerous papers and recently written several book chapters related to water system microbiology for PDA and ISPE publications. He is currently Vice-Chair of the USP Pharmaceutical Waters Expert Committee through which he authored the complete rewrite of USP’s Chapter <1231> which many consider to be USP's “pharmaceutical water bible”.
