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: 08/21/2012 9:00 am
End: 08/21/2012 11:00 am
This 120-minute webinar will help medical device manufacturers to understand what you need to do to ensure that your process, the methods, and the procedures that you have established to implement the requirements for design controls are in perfect order. Why Should You Attend: In the global economy and supplier partnership, it is critical that every product development process for product, service or logistics, is well designed - that the design inputs are well defined, design outputs are documented and auditable as well as design transfers are successful. There are millions of dollars spent on design transfers that are not effective - and instead of creating a benefit and remove liability, they instead increase the liability and risk. There have been number of FDA findings and warning letters issued against the design control processes to all sizes of medical and pharmaceutical manufactures. This 2-hr session will review the FDA design control requirements under GMP regulations and show how, as a medical device manufacturer, you can design faster, transfer faster, make faster yet never compromised quality and be in full compliance with FDA requirements. By attending this training, you will be in a position to ensure that your process, the methods, and the procedures that you have established to implement the requirements for design controls are in perfect order. Areas Covered in the Seminar:
Event Details: Date: August 21, 2012 Start: 08/21/2012 10:00 am
End: 08/21/2012 11:30 am
This 90-minute session on risk-based verification and validation planning will discuss "must have" elements from the U.S. FDA cGMP, ICH Q9 and ISO 14971 for hazard analysis and product risk management, and show how you can integrate these into a company's quality management system. Why Should You Attend: FDA Warning Letters and recent high-profile recalls indicate major cGMP deficiencies in big name device and pharma companies. And now the FDA is taking an even tougher stance. One major failing is lack of sufficient or targeted risk-based V&V planning. Why do companies need a Master Validation Plan? What are the must have elements from ISO 14971 and ICH Q9 for hazard analysis and product risk management? How can these be integrated into a company's quality management system. Areas Covered in the Seminar: * Process Validation -- New regulatory expectations. Start: 08/21/2012 10:00 am
Overview: This live webinar concentrates on identifying good and bad cleanroom behavior. It provides training in cleanroom contaminants and how they are affected by humans. The key benefits of this course are: In-dept understanding of cleanroom contaminants. Areas Covered in the Session: Who Will Benefit: Charles Gyecsek is formerly of Hoffman LaRoche where he worked primarily in Validation, Microbiology, Quality, and Operations. During his career Charles set-up and managed one of the largest GMP cleanroom facilities in the US, encompassing more than 200 rooms in 3 separate facilities. Charles' extensive experience involves plant start-up, cleanroom design and renovation, quality system auditing, regulatory submission writing, microbiology, equipment and cleaning qualification, utility validation, water system design and validation, aseptic processing, risk management, and regulatory inspections and responses. Charles is currently president of MIJ Enterprises whose Compliance Division provides personalized consulting and training services within FDA regulated industries pertaining to pharmaceuticals, diagnostics, devices, and biotech products. Their core mission is to help clients maximize the benefit of a quality system in order to provide innovative products and exceptional services to their customers. Price List: Phone: 800-447-9407 webinars@globalcompliancepanel.com Start: 08/21/2012 10:00 am
End: 08/21/2012 11:30 am
This 90-minute webinar will show how to evaluate disinfectants against the types of microorganisms recovered from the cleanroom environment. You will learn how to design and execute an effective disinfectant qualification study that provides a scientific rationale for developing an effective disinfection/cleaning program. Why Should You Attend: Proper selection and use of disinfectants are critical to microbial contamination control in aseptic processing environments. To evaluate disinfectants a good understanding of methods available to perform disinfectant qualification studies is important. This 90-minute webinar provides the exact guidance required for selecting disinfectants, planning and costing a disinfectant qualification study, important elements of the study protocol, managing the study whether performed in-house or at contract laboratory, and reviewing data for its applicability to cleaning procedures. The goal of performing this study is to control microbes in the facility and prevent them from infiltrating into process or product or forming biofilms. Learning Objectives: Participants will understand disinfectants, hard surfaces in cleanroom, cleaning challenges and the nature of cleanroom flora to develop a study and implement the resulting data to control contamination. Event Details: Date: August 21, 2012 | ||
