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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: 08/16/2012 9:00 am
Course Description: Implementing an effective system for corrective action and preventive action can be a major challenge. FDA illustrates the point in its published information on Warning Letters. FDA cited the CAPA subsystem in 81 of 89, 91%, of Warning Letters issued in 2010, the most recently available data. The CAPA subsystem includes nonconforming material, corrective and preventive action, and complaints (820.90, 820.100, 820.198). The trend continues in recent warning letters. This interactive two-day course provides the tools you need to develop and implement an effective medical device CAPA system. In addition to FDA QSR, the course covers the corresponding requirements in ISO 13485 as well as the linkage to risk management in ISO 14971. Corrective action requirements extend beyond the basic QMS to include field actions, so the course includes adverse event reporting, Corrections & Removals, Field Safety Corrective Actions, and Field Safety Notices. CAPA does not stand alone; it is most effective when it is an integral part of the Quality Management System and influences all of the other subsystems. The overarching objective of the course helps the participants develop the tools and methods. The course utilizes a broad variety of available material including FDA guidance documents, Global Harmonization Task Force (GHTF) guidance documents, ISO guidance documents, and European Union medical device guidance documents (MEDDEV). Course Objectives:
Start: 08/16/2012 10:00 am
End: 08/16/2012 11:00 am
Description: This webinar will show how you can use the credit risk management system, and within it, the Credit Industry Group, as a road map to establishing and maintaining the credit controls that will in turn support an understanding of your customer's ongoing credit worthiness. Why Should You Attend: Every company that aims to operate successfully, can only do so when they have a handle on understanding the creditworthiness of their customers. When our customers are "creditworthy" we can also say they are "trustworthy", and that we trust them to pay our invoices for the products and services that were sold to them in advance of payment. The Credit Risk Management System is every company's road map to establishing and maintaining the credit controls that will in turn support an understanding of our customer's ongoing credit worthiness. Unfortunately, a customer's credit worthiness can go from honest and straightforward to downright deceptive. Since trying to maintain an understanding of our customer's credit worthiness can be a daunting endeavor, this webinar will present the components of a credit policy that reflect the road map to maintaining a sound credit risk management system. Within the credit risk management system we will explore one of the most highly effective credit risk management tools, the Credit Industry Group. Event Details: Date: August 16, 2012 Start: 08/16/2012 10:00 am
End: 08/16/2012 11:00 am
Description This seminar will cover the various container closure systems that are available for use with liquids, lyophilized products (bulk and single use), suspensions, emulsions, and bulk powders. As formulations get more complex, due to the chemical and physical instability of many of the new biologically based molecules (monoclonal antibodies, vaccines, etc.), the container closure systems have to adapt as well. Understanding how the container closure system can affect product stability, and knowing what options are available from the different manufacturers, is critical in ensuring long term stability and closure system integrity. In addition to discussing various vial and stopper configurations, specialized systems, including prefilled syringes, will be discussed along with the different specialized coating options that are available for these systems. Learning Objectives: Attendees will Learn how to identify the different types of vials and stopper for specific needs. Start: 08/16/2012 10:00 am
Overview: A 510(k) is a premarket submission made to FDA to demonstrate that your device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device that is not subject to PMA. There are three types of Premarket Notification 510(k)s that may be submitted to FDA: Traditional, Special, and Abbreviated. The Special and Abbreviated 510(k) methods were developed under the "New 510(k) Paradigm" to help streamline the 510(k) review process. Product modifications that could significantly affect safety and effectiveness are subject to 510(k) submission requirements under 21 CFR 807 as well as design control requirements under the Quality System (QS) regulation. Under the QS regulation, all Class II and III devices and certain Class I devices are required to be designed in conformance to 21 CFR 820.30 Design Controls. FDA provides guidance and this course will address key resources when making critical decisions. Objectives: Introduction and Regulatory Background Those who will benefit includs: All Levels of Management, including technical and laboratory personnel who desire to understand what it takes to prepare and submit a bulletproof 510(k) to FDA while at the same time are aware of the changing regulatory landscape regarding FDA's proposed changes to the 510(k) process. Price List: Phone: 800-447-9407 webinars@globalcompliancepanel.com Start: 08/16/2012 10:00 am
Overview: Controlled documents are one of the foundational building blocks of a Quality Management System (QMS) for regulated industries. Too often, controlled documents are cluttered, confusing, and cause many errors due to the way they are created, organized, and managed. This webinar applies the Theory of Lean Documents and the corresponding Theory of Lean Configuration to this key part of a QMS. Why you should attend: Do you find yourself constantly struggling to create, manage, and maintain all of the information found in controlled documents - which is often redundant, repetitive, and chained together in a cumbersome way? Do you find that your design and manufacturing resources are spending way too much time on documentation and not enough on engineering, quality, and operations? This webinar presents a fresh new approach based upon solid principles and proven practices - as well as an alternative that avoids many of the pitfalls of traditional ways of preparing these documents. Areas Covered In the Session: Who will benefit: José Mora is a Principal Consultant specializing in Manufacturing Engineering and Quality Systems. For over 29 years he has worked in the medical device industry specializing in manufacturing, process development, tooling, and quality systems. Prior to working full time as a consulting partner for Atzari Consulting, José served as Director of Manufacturing Engineering at Boston Scientific and as Quality Systems Manager at Stryker Orthopedics, where he introduced process performance, problem solving, and quality system methodologies. During that time he prepared a white paper on the application of lean manufacturing methods to the creation and management of controlled documents and a template for strategic deployment. José led the launch of manufacturing at a start-up urology products company as Director of Manufacturing for UroSurge, Inc. at the University of Iowa’s business incubator park in Coralville, IA, creating a world-class medical device manufacturing operation, with JIT, kanban systems, visual workplace and lean manufacturing practices. José worked for 10 years at Cordis Corporation, now a Johnson & Johnson company, where he led the successful tooling, process development and qualification of Cordis’ first PTA (percutaneous transluminal angioplasty) catheter. His medical device experience includes surgical instruments, PTA & PTCA dilatation and guiding catheters, plastic surgery implants and tissue expanders, urology implants and devices for the treatment of incontinence, delivery systems for brachytherapy, orthopaedic implants and instruments, and vascular surgery grafts and textiles. During his time at Cordis, José managed the Maintenance and Facilities Department, taking that operation to a level rated as “tops” by the UK Department of Health and Social Services (DHSS) during one of their intensive audits. Jose managed Manufacturing Engineering as part of the Guiding Catheter Core Team of managers, a team that took the Cordis Guiding Catheter business to lead the market, bringing it up from fourth place. By introducing world-class techniques, the Guiding Catheter design and manufacturing was completely re-engineered for robust design and tooling, under Jose’s leadership. He was also instrumental and played a leadership role in the complete re-engineering of the Tooling Control System, including design drafting, the tool shop and technical support. Wherever he has worked, he has a track record of introducing world-class methodologies such as Kepner-Tregoe, Taguchi techniques, Theory of Constraints, Lean Manufacturing, Five Ss (Visual Workplace), process validation to GHSS standards, and similar approaches. Price List: Phone: 800-447-9407 webinars@globalcompliancepanel.com Start: 08/16/2012 10:00 am
End: 08/16/2012 11:00 am
This webinar will provide a step-by-step procedure to all medical device companies that need to bring their product design history files up to date with current standards. Why Should You Attend: Many regulated companies have not brought their old products up to current FDA standards and are not in total compliance. This webinar defines the criteria to be used for medical products design history file remediation. For example companies should be compliant to 14971:2007. Design History Files need to be updated to meet current standards. The FDA expects risk management to be integrated into the company quality system. Old medical devices need to have a risk assessment for each product and updated validations for product and processes. Each product needs to have a gap analysis to determine obsolescence or validate. It should also describe the risk acceptance criteria as well as roles and responsibilities of each member on the team. In this webinar, we will discuss practical steps you can follow to bring your product design history files up to current standards. Areas Covered in the Seminar:
Event Details: Date: August 16, 2012 Start: 08/16/2012 10:00 am
End: 08/16/2012 11:30 am
This webinar will show how you can keep your candidate hiring and termination decisions lawful and purely job-related when using information found on social media sites as part of the process. Learning Objectives: In this webinar you will learn how you can search for information about prospective employees on Social Media sites, such as Facebook and LinkedIn, while maintaining the requirement to keep your selection process job-related. Areas Covered in the Seminar: - Need to keep employee selection techniques job-related (federal requirement, with long case history that affirms this necessity. Start: 08/16/2012 11:00 am
The need for business analysis and business intelligence for financial services organizations is greater today than it has ever been. In a highly competitive marketplace, organizations rely on analytics to understand customer behavior and improve customer loyalty. Critical data brings valuable insight into overall customer demographic and helps to determine the specific segments of customers that are at a higher risk of exiting. To drive better business results, it is important that firms translate these analytics into actionable insights, which can help them gain business agility to meet the changing customer dynamics. | ||
