Webinar Duration: 60 minutes
RECORDED: Access recorded version only for one participant; unlimited viewing for 6 months (Access information will be emailed 24 hours after the completion of payment)
SPEAKER: T.C. Soli
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 â€œawareness trainingâ€� 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.
Why Should You Attend:
Someone must spearhead the effort to control a manufacturing site's microbial contamination issues. Though it typically is QA's responsibility to "assure" that production has no facility, raw material, or process contamination that could lead to product contamination, QA is not typically staffed by microbiologists who truly understand all the issues with this aspect of quality assurance. Therefore, it naturally should fall to the microbiology lab to take a lead role since likely no one else at the site has that expertise or is so intimately involved in the contamination assessment testing. Those supervising and doing this testing have a crucial role in the site's microbiological condition. They must be more than a data mill -- they must also interpret the data, even when not asked to do so. In spite of the logical role the Micro Lab can serve in proactively controlling microbial contamination on-site, there are often many impediments to their being able to assume this role. They are not insurmountable, but they must be overcome for the Labs to be able to help. Don't miss this webinar if you want to better understand how the micro lab can be more effectively utilized to prevent or head off microbial contamination issues as well as effectively resolve such problems should they have already occurred.
Areas Covered in the Session:
- How contamination is controlled
- Why the microbiology lab should lead in contamination control
- Routine contamination evaluation activities
- Microbiological training
- Root cause and impact investigations
- Impediments to leadership
- Observed contamination correlations & doing the right thing
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
T.C. Soli, is a Ph.D. Microbiologist and President of Soli Pharma Solutions, Inc. (www.solipharmasol.com), and is a consultant serving consumer products and FDA-regulated industries with training and contamination troubleshooting expertise covering water systems, sterile and non-sterile products and processes, and microbiological laboratory operations. Prior to full time consulting starting in 2004, he had 25 years of pharmaceutical operating company experience. He has lectured extensively at conferences and webinars, authored numerous papers and written several book chapters related to water system microbiology and biofilm control for USP, PDA and ISPE publications. He is currently serving in his third five-year term on USP Expert Committees responsible for Pharmaceutical Waters during which he completely rewrote USP Chapter which many consider to be USP's "pharmaceutical water bible".
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