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.
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"This course is certified by Regulatory Affairs Professional Society (RAPS). Attendees of Live Webinar are eligible for 1 RAC Points up on full
completion of the course."
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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, Ph.D. is President of Soli Pharma Solutions, Inc, with lecturing, auditing, and troubleshooting expertise covering water systems, sterilization, aseptic processing, contamination control, and microbiological laboratories. He has over 31 years of pharmaceutical experience as a consultant and with DSM Pharmaceuticals, Glaxo Wellcome, Burroughs Wellcome, and Pfizer. Dr. Soli’s career-long water systems and contamination troubleshooting, coupled with water-related USP, ISPE, PhRMA, and PDA committee involvements, afford him practical knowledge about process and contamination control; cleaning, sterilization and process validation; and all aspects of high purity water systems.
He is in his third 5 year term on USP Expert Committees responsible for Pharmaceutical Water, previously served 5 years on the Advisory Panel to the USP Microbiology Subcommittee, and helped develop the Water Conductivity and TOC specifications used by USP and adopted world-wide. He has authored many articles and chapters in books and industry guides published by USP, PDA and ISP.
