Conference & Events
Leadership in Manufacturing Contamination Control - Webinar By GlobalCompliancePanel
The Microbiology Lab must take leadership in contamination control support for production because it is the hub of the necessary technical expertise.
Date: 05 June 2012 10:00 - 11:30
1000 N West Street
United States of America
Contact for Event Information
Name : Online Training
1000 N West Street
United States of America
Contact Useful link:http://www.globalcompliancepanel.com
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 31+ year career he has lectured extensively at conferences, authored numerous papers and recently written several book chapters related to water system microbiology for USP, PDA and ISPE publications. He is currently serving in his third five-year term on USP Expert Committees responsible for Pharmaceutical Waters through which he authored the complete rewrite of USP Chapter <1231> which many consider to be USP's "pharmaceutical water bible".
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.
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
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
Live : $245.00
Corporate live : $995.00
Recorded : $295.00