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: 08/28/2012 10:00 am
End: 08/28/2012 11:00 am
This 510(k) training will discuss the submission process and the contents required by the FDA for a successful 510(k) submission. It will also provide an understanding of the common pitfalls, delays, and possible preventive measures. Why Should You Attend: This Medical device training will provide an understanding of how to get a device requiring a 510(k) submission to market quickly. Knowing when and how to properly submit a 510(k) for a device or change to a device is critical to a company’s regulatory and financial health. Your goal is to get the 510(k) through the review process as quickly as possible. This presentation will also distinguish between the standard, special and abbreviated 510(k)s, and explain when each is appropriate. This course will describe the submission process and the contents required by the FDA for a successful submission. Who will Benefit: This webinar will provide valuable assistance to all medical device companies that prepare 510(k) submissions. The employees who will benefit include: * Executive management Start: 08/28/2012 10:00 am
Overview: Excel® Applications are widely used in laboratories, offices and manufacturing e.g., for data capture, data manipulation and report generation. Regulations such as HIPAA, Sarbanes Oxley Act and FDA's GxP and 21 CFR Part 11 require users of software and computer systems to demonstrate and document data accuracy, integrity and confidentiality. Out-of-the box Excel® has not been designed for regulated environments. However, with a good knowledge of Excel® capabilities combined with good procedures and practices on how to validate and use Excel® requirements can be met. For example, the FDA is widely using Excel® and complies with its own regulations. For easy implementation, attendees will receive: Areas Covered in the Session: Who Will Benefit: Ludwig Huber, Ph.D., is Director of Labcompliance and Chief Advisor for global FDA compliance at Agilent Technologies. He is the editor of Labcompliance, the global on-line resource for validation and compliance issues for laboratories. He is the author of the books "Validation and Qualification in Analytical Laboratories, and "Validation of Computerized Analytical and Networked Systems", Informa Healthcare. Price List: Phone: 800-447-9407 webinars@globalcompliancepanel.com Start: 08/28/2012 10:00 am
End: 08/28/2012 11:30 am
Description: This 90-minute webinar will cover the global Biosimilar guidances and provide an overview of analytical studies for a Biosimilar CMC package. Why Should You Attend: Analytical characterization and comparability studies will determine the amount of Clinical and non-clinical studies required for registration of a Biosimilar product. Hence, Analytical Strategy is a critical element of Biosimilar product development plan. A comprehensive analytical package can minimize the amount of clinical studies and control costs of a Biosimilar development program. This 90-minute session will review the global Biosimilar guidances and provide an overview of analytical studies for a Biosimilar CMC package. Areas Covered in the Seminar:
Event Details: Date: August 28, 2012 Start: 08/28/2012 10:00 am
End: 08/28/2012 11:00 am
In this 90-minute training on laboratory Out-of-specification (OOS) investigations, you will learn what constitutes an OOS observation, what is the OOS investigation process described in the OOS guidance and steps to be taken in the laboratory in the event of an OOS observation. Why Should You Attend: Inadequate procedures for laboratory Out-of-specification (OOS) investigations remain high on the list of FDA observations. The FDA has issued a guidance on the topic. OOS procedures and investigations are still a topic of FDA Investigator review and findings. An out-of-specification laboratory observation triggers emotional and political actions that inhibit a productive investigation with a timely conclusion. There is still confusion in the laboratories as to how an out-of-specification result should be handled and investigated. In this webinar we will discuss the investigation that goes on within the laboratory. Although the focus will be on the FDA Guidance, the discussion will include suggestions for a process that will meet the FDA expectations. Areas Covered in the Seminar:
Event Details: Date: August 28, 2012 Start: 08/28/2012 10:00 am
Overview: Excel® Applications are widely used in laboratories, offices and manufacturing e.g., for data capture, data manipulation and report generation. Regulations such as HIPAA, Sarbanes Oxley Act and FDA's GxP and 21 CFR Part 11 require users of software and computer systems to demonstrate and document data accuracy, integrity and confidentiality. Out-of-the box Excel® has not been designed for regulated environments. However, with a good knowledge of Excel® capabilities combined with good procedures and practices on how to validate and use Excel® requirements can be met. For example, the FDA is widely using Excel® and complies with its own regulations. For easy implementation, attendees will receive: Areas Covered in the Session: Who Will Benefit: Ludwig Huber, Ph.D., is Director of Labcompliance and Chief Advisor for global FDA compliance at Agilent Technologies. He is the editor of Labcompliance, the global on-line resource for validation and compliance issues for laboratories. He is the author of the books "Validation and Qualification in Analytical Laboratories, and "Validation of Computerized Analytical and Networked Systems", Informa Healthcare. Price List: Phone: 800-447-9407 webinars@globalcompliancepanel.com Start: 08/28/2012 10:00 am
End: 08/28/2012 11:00 am
Description : This webinar will discuss leading and emerging risk management practices and show how your organization’s risk management capabilities can be improved. It will present proven techniques that you can use to assess and improve your risk management design and operating effectiveness Why Should You Attend: Organizations are exposed to governance, compliance and ethical risks daily. Coupled with the current economic, regulatory and social climate, these risks have propelled corporate governance, compliance management and integrity to a top business priority. More than ever, the business community perceives the need not only to articulate the principles of good governance, compliance, risk management, and ethics — but also to integrate these concepts into the fabric of day-to-day business — and use them to drive better performance. In this session, we will discuss leading and emerging risk management practices and demonstrate how to improve your organization's risk management capabilities. The speaker will present proven techniques and tools that you can use to assess and improve your risk management design and operating effectiveness. Participants will be provided an audit framework that they can use and also resources that you will find useful. Event Details: Date: August 28, 2012 Start: 08/28/2012 10:00 am
End: 08/28/2012 11:00 am
This webinar covers, in great detail, the risk management strategies for business financing. You will learn how to determine the right type of financing for your business, choosing the right financial source, understand common risks and risk minimizing strategies. Why Should You Attend: A business/organization undergoes an additional substantial pressure when it gets outside financing. The process of Business Financing has to be carefully planned and potential risk has to be assessed and minimized. This webinar will guide you through a sophisticated process of Business Financing and its Risk Management and show you why Risk Management for Business Financing has to become an organic part of your Enterprise Risk Management (ERM). You will learn how to determine the right type of financing for the business and, choosing the right financial source and the importance of establishing good communication with your lender/investor. The presenter will detail many of the possible common risk Areas Covered in the Seminar:
Event Details: Date: August 28, 2012 Start: 08/28/2012 10:00 am
End: 08/28/2012 11:30 am
This 90-minute webinar will recommend strategies for filing successful Citizen Petitions and Suitability Petitions with the U.S. Food and Drug Administration. You will learn techniques for drafting and filing successful petitions including the required elements of such petitions and the types of substantiation needed to support them. Why Should You Attend: The webinar is intended to provide participants with strategies for drafting targeted and effective Citizen Petitions and Suitability Petitions for submission to FDA. Recommendations for strengthening petitions and increasing the chances of ultimate success will also be provided. Learning Objectives: Upon completion of the course you will: Start: 08/28/2012 10:00 am
End: 08/28/2012 11:30 am
This 90-minute course will is designed to help you logically investigate and define the specific quality attributes that your lab water systems need. By attending this training, you will be able to determine the potential deficiencies in your chosen solutions to providing water for your laboratories, rectify them and ensure regulatory compliance. Why Should You Attend: Maintaining appropriate quality of lab water systems is perhaps more important than many applications of manufacturing’s water systems. This is because the tests performed on manufacturing’s products can be affected by the lab water quality in insidious, hard to detect ways, which could cause perfectly good products to appear to fail testing or bad product to appear to pass. This webinar will assist the attendees in logically investigating and defining the specific quality attributes their lab water systems need and not just default to manufacturing’s required water quality. The need or lack thereof to validate your water system will also be discussed along with how that validation may be very different from that employed for manufacturing’s water system. So you may not be doing enough for your water system or you might be going well overboard. Using packaged waters and/or small self-contained water purification systems are often considered alternatives to having and maintaining a full-fledged water system, but these water sources must also meet all compendial water quality requirements. They have unique and often unrealized challenges that may make them less cost effective than thought. Event Details: Date: August 28, 2012 Start: 08/28/2012 10:00 am
Overview: Design Inputs, Design Outputs, and Traceability matrices present a challenge to almost all industries that apply design controls. Typically, these cause the creation and maintenance of duplicate information across various documents - a major source of errors. This webinar applies the Theory of Lean Documents and the corresponding Theory of Lean Configuration to avoiding these errors, while presenting a fresh new approach to these key and related documents. Why you should attend: Do you find yourself constantly struggling to create, manage, and maintain all of the information found in Design Inputs, Design Outputs, and traceability matrices - 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 and design? 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: 08/28/2012 2:00 pm
Explore effective CBT techniques that will help your clients restructure the thought processes that hinder success. Discuss tips for identifying and evaluating negative cognition, and apply strategies to specific clinical presentations. Full Description: self-statements. This webinar will provide a step-by-step illustration of techniques to work with unhelpful cognition in CBT. Webinar participants will gain an understanding of the rationale and purpose of cognitive restructuring, as well as strategies for implementing specific cognitive restructuring techniques with clients. Course Includes: What You Will Learn: Your Presenter: the author or editor of 10 books, many on Cognitive Behavioral Therapy, and has published approximately 100 journal articles and book chapters. Dr. Wenzel has provided intensive training to over 125 masters and doctoral level clinicians in Cognitive Behavioral Therapy. Dr. Wenzel is a diplomate of the Academy of Cognitive Therapy, has held leadership positions in the Association for Behavioral and Cognitive Therapies, and is on the scientific advisory board of the American Foundation for Suicide Prevention. Disclaimer: is no charge for a CCE web account. It is recommended that you join the meeting 15 to 20 minutes early. Speaker phone sound quality is poor and it is recommended that they not be used to listen to the event. Technical requirements: can setup prior to the meeting by following this link: https://apidemoeu.webex.com/apidemoeu/meetingcenter/mcsetup.php Who Should Attend: Start: 08/28/2012 2:00 pm
In recognition of August as Connected Educator Month, GoingOn Networks today announced that it will kick off its free “Connected Educator” webinar series on August 28th with the session, “Benefits of Deploying an Institution-wide Faculty Commons: How CUNY, National University and Academia.edu are Utilizing Social Technologies to Improve Professional Development, Curriculum Sharing, Grant Collaboration and Broader Faculty Communications.” The 45-minute webinar begins at 2pm ET/11am PT on Aug. 28 and it will also be offered again at 2pm ET on September 18. Registrations are currently being accepted on the GoingOn website. Space is limited for these free sessions. Professionals from the office of CIO, academic affairs and continuing education, provosts, chancellors, deans of faculty and others interested in attending either session should go to the following link to register: | ||
