Events
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The Online Seminar shows the Possibilities of the use of Desktop-Sharing Software. The Online-Seminar is free of charge an will contain the following topic. How to Setup the Software. The Webinar will held on request, the duration is approx. 30 Minutes Further Information to the Online-Seminar Start: 02/22/2012 9:00 am
Course Description: All pharmaceutical, biologics, and medical device facilities are likely to have high purity water systems. In spite of this purity, microorganisms can flourish within these systems and lead to undesirable contamination of facility processes and their products. Of all the individuals at the facility who should understand the microorganisms in water systems and how best to monitor and control and them, it should be the site’s microbiologists. Sadly, this is often not the case due to the lack of familiarity with biofilm and its impact on water system sampling, testing, sanitization, and routine maintenance. This course is designed to provide a microbiology-focused education about all aspects of water systems and how biofilm manages to thrive there. Prior microbiological education or training, though a plus, is not a requirement. The instructor can provide the necessary background needed to understand this very important subject matter. This understanding is essential to the proper design, validation, operation, monitoring, and maintenance of a high purity water system. Without this understanding, water system control consists of a set of rules that often don’t work and can cause very costly system downtime or even product recalls. Start: 02/22/2012 10:00 am
There is a pervasive public perception that the FDA has been ineffective in protecting the public. Recent news events seem to support this perception. The FDA is working hard to change that perception. Industry must be prepared to adapt, and recognize that such adaptation will actually work to their long-term benefit. This webinar will discuss and evaluate the effects that this call for change has on a company and its selection, audit, use and on-going relations with its suppliers of services and products / components. What are the "new" expectations for the COA and COC? How can companies address the FDA's stated desire to require "on-site" audit of all Pharma suppliers? Expectations for meaningful, results driven actions that addresses and resolve any underlying compliance issues or product problems are increasing among regulatory agencies worldwide. To meet the new regulatory climate and be competitive, companies need to reevaluate their vendors and the methods used in selecting, evaluating, auditing, retaining or cutting adrift such regulatory "partners". Why you should attend: The last few years have seen the U.S. FDA come under increasing negative public scrutiny. High profile drug recalls, food chain problems and contamination, import problems, resignations. The commissioner vows no more "business as usual". Data in cGMP records must be more science based. Companies are outsourcing more; with some thinking they can also outsource some of their cGMP compliance as well. Thus, the FDA has indicated that a key area they are focusing attention is on a company's suppliers, for both services and products / components. Why needed? FDA expectations? How are successful companies meeting this challenge. Tools that need to be put in place or enhanced. The required supporting infrastructure for COAs and COCs. Meeting the challenges of more "on site" audits. Getting supplier buy-in. Coping with "rogue" suppliers. Areas Covered in the Session: Price List: webinars@globalcompliancepanel.com Phone: 800-447-9407 1000 N West Street | Suite 1200 | Wilmington | DE | Zip 19801 | USA Start: 02/22/2012 10:00 am
Validation of reusable medical devices requires that the manufacturer develop methods for cleaning (after use) washing to remove all foreign matter possibly disinfecting and repackaging for the next use. The diversity of medical devices their intended use and classification in accordance with the food and drug administration requires that the manufacturer develop and validate the reprocessing of the medical device. Reprocessing usually entails that the manufacturers thoroughly understand the design of the device and what potential hazards can occur if the device is not properly cleaned before reprocessing. This usually means that the manufacturer must establish clear and efficacious instructions on how to reprocess the medical device before reuse. Why you should attend: To assist you in the identification of key factors during the development of your protocol. you will be guided on how to identify key factors in the protocol design process. Key factors such as selection of chemical agents specifically biocidal agents and or biostatic agent(s). Identify testing that will be required to evaluate these proposed agents Biocompatibility issues, such as should you test for cytotoxicity, tolerable contact limit (TCL) as stated in ISO 10993-7. If you require sterilization of your reusable should packaging and penetration issues be addressed. What will be the required sterility specifications for your product. Sterility assurance issues will be discussed. Areas Covered In the Session: Who will benefit: Price List: webinars@globalcompliancepanel.com Phone: 800-447-9407 1000 N West Street | Suite 1200 | Wilmington | DE | Zip 19801 | USA Start: 02/22/2012 11:00 am
Live 30-Minute Webinar, Bonus VDI Whitepaper | ||
