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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 Allan Gonsher and Kids Inc are pleased to a offer a series of Play Therapy Webinars. If your work with children, or want to work with children, these are workshops that you can not afford to miss. Each webinar workshop offers one hour of continuing education credit. Start: 07/26/2012 10:00 am
End: 07/26/2012 11:30 am
This 90-minute webinar will show how to select the best technology and format combination to develop a compliant immunogenicity binding method, and provide a check-list that itemizes all the requirements to develop a compliant validation protocol. The principal components of a meaningful immunogenicity program consist of an initial binding screen followed by confirmation and quantitation of the positive samples. This 90-minute webinar first reviews the technologies and formats currently in use to detect unwanted immunogenicity. These sections will help the scientist to a priori select the appropriate procedures to specifically meet the needs of their product. The second part of the webinar provides a step by step approach to develop a method that will meet the current validation standards regardless of the technology and format that is utilized. Case studies are cited throughout the webinar to demonstrate the impact of the method on immunogenicity results. Finally, a check-list is supplied to ensure that essential requirements are in place to proceed into validation.
Start: 07/26/2012 10:00 am
End: 07/26/2012 11:15 am
Overview: Within the next few weeks and months the FDA will continue to conduct a series of Part 11 related inspections. Planned routine inspections will be extended to evaluate the companies' practices to ensure integrity, authenticity and availability of electronic records, The program is the long awaited next step for Part 11 and nevertheless it came as a surprise to the industry. The FDA already has issued many warning letters related to inadequate integrity, security and availability of electronic records but also related to validation of software and computer systems. There are many questions about the program, what inspectors are looking at and to further steps. The webinar will have the answers. And using industry proven case studies attendees will learn how to prepare their organization for trouble-free Part 11 related inspections. Areas Covered in the Session: Price List: Start: 07/26/2012 10:00 am
End: 07/26/2012 11:00 am
Overview: An effective complaint handling system is an extremely important part of any quality system. Manufacturers should understand that any complaint received on a product shall be evaluated and, if necessary, thoroughly investigated and analyzed, and corrective action shall be taken. The results of this evaluation should lead to a conclusion regarding whether the complaint was valid, what the root cause of the complaint was, and what action is necessary to prevent further occurrences. Complaints cannot be ignored. They are an excellent indicator of problems with the use, design, and/or manufacture of a product. A single complaint that is thoroughly investigated may lead a company to take remedial or corrective action. It may also take an ongoing analysis of numerous complaints before a trend is spotted that causes a company to initiate changes in their product, labeling, packaging or distribution. The regulatory expectations for both pharmaceuticals and medical devices will be emphasized as well as overview of best practices for timely and effective investigations. Areas Covered in the Session: David R. Dills, an independent Regulatory & Compliance Consultant with more than 22 years of hands-on experience and a proven track record within the FDA regulated industry, has an extensive regulatory and compliance background with Class I/II/III and IVD devices and managing and handling activities within the global regulatory and compliance landscape. He manages quality, regulatory and compliance projects with multiple competing priorities having a direct impact on site operations and commercial opportunities and develops strategies for governmental approval to introduce new products to market, provides guidance and direction on regulatory and compliance requirements and prepares/reviews worldwide submissions/dossiers/technical files and addresses requirements in the EU, Pacific Rim and The Americas regarding all aspects of device commercialization and especially FDA activities. Background encompasses broad capabilities in quality systems, validation, regulatory affairs, GxP compliance, auditing, interfacing with the regulatory agencies, managing enforcement actions and mitigating compliance exposure for companies, working with Notified Bodies, AR’s and demonstrates credible experience to maximize business performance in the devices arena. He strives to optimize business performance through proactive strategies to mitigate compliance exposure by providing strategic and tactical solutions that facilitate the achievement of regulatory milestones. David has been previously affiliated with well-known device manufacturers and service providers, including a well-known CRO and has served in various quality, regulatory and compliance management and advisory capacities with increasing responsibilities. David is an accomplished industry speaker and author of technical and compliance related topics published in industry journals. Please refer to his profile provided herein for additional information about his background. Start: 07/26/2012 10:00 am
End: 07/26/2012 11:30 am
Description: This session will compare commercial and standby letters of credit, standard and silent letter of credit confirmations, bank and corporate guarantees, forfaiting, factoring, credit insurance, credit derivatives, and foreign exchange contracts from the perspective of what risks each one covers. Learning Objectives: By attending this training, you will be able to:
Start: 07/26/2012 10:00 am
End: 07/26/2012 11:00 am
This webinar will help you understand the process, requirements, quality and safety considerations for demonstrating biosimilarity to a Reference Product. You will learn about what type and how much clinical data are needed to support a showing of biosimilarity. Why Should You Attend: On February 9, 2012, the U.S. Food and Drug Administration (“FDA” or “Agency”) released three highly anticipated guidance documents designed to answer industry questions regarding the development and approval of biosimilars (a/k/a follow-on biologics). The guidance documents provide specific advice and recommendations on steps applicants can take to obtain approval of a proposed biologic product under FDA’s proposed abbreviated approval pathway. The Biologics Price Competition and Innovation Act of 2009 (“BPCIA”) amended the Public Health Service Act by adding Section 351(k) which created an abbreviated approval pathway for biological products that are found to be “highly similar” or “interchangeable” with a reference biological product (e.g., vaccines, antibodies, blood and blood components, gene therapies, tissues, and proteins) that have already been approved or “licensed.” Areas Covered in the Seminar: - FDA's regulation of biosimilars. Start: 07/26/2012 10:00 am
End: 07/26/2012 10:00 am
Overview: This CAPA training program helps you to understand, in 10 easy steps, the entire CAPA process. It includes elements of Quality Tools, Team Effectiveness, Awards & Recognitions, and Verification & Validation of actions taken. Attend this webinar to grasp the A to Z of CAPA and learn how to implement & manage it for success. Why Should You Attend: We have found out, through auditing many organizations world-wide that the organizations are pretty good when it comes to corrective actions yet they are not nearly as good when it comes to the preventive actions. This webinar should provide you with enough ideas, suggestions and HOW TOs that you and your teams and organization overall get much better on the preventive actions and even better on the corrective actions. Includes all elements of CAPA process step as required by ISO and regulatory agencies. In addition, it is represented in a practical and proven manner which can be immediately applied in your organization. Areas Covered in the Seminar: Jasmin NUHIC serves a major medical devices OEM as a Sr. Compliance Quality Engineer and 21 CFR Part 11 Subject Matter Expert. He also served ASQ section as a chair for two consecutive terms, has taught quality certification exam prep course, completed numerous software validations and obtained over 25 different certifications in leadership, quality, software validations, and more. Jasmin NUHIC has conducted Webinars on this and other topics with high attendance and appreciation. Start: 07/26/2012 10:00 am
End: 07/26/2012 11:00 am
This webinar discusses the high risks of scientific misconduct in regulated studies. You will understand the main issues in producing study results of the highest integrity, learn how managers can implement a system for ensuring accurate and reliable data, understand the "red flags" of questionable data or reporting and develop a plan for identifying the high-risk steps in your operation. Why Should You Attend: This presentation discusses the high risks of scientific misconduct in regulated studies. It distinguishes between large and small errors in misjudgment and how QA professionals manage these occurrences. It also describes a plan for ensuring the highest ethical standards in your lab. The webinar begins by giving a brief introduction to terms related to regulatory action, such as “fraud,” “misconduct,” “injunction,”, “disqualification,” etc. It describes the root causes of scientific misconduct. These root causes are discussed with special attention to the various individuals most likely to make these errors in judgment. Thus, the webinar covers ethical behavior with respect to sponsors, testing facility management, study directors, study scientists, regulatory affairs professionals, and quality assurance professionals. The webinar then summarizes the main warning signs of scientific misconduct from the perspective of regulatory agencies and auditors. This discussion covers “red flags” in raw data, reporting, and the sponsor-CRO relationship. Areas Covered in the Seminar: - How to recognize fraud and scientific misconduct Start: 07/26/2012 10:00 am
End: 07/26/2012 11:30 am
This 90-minute webinar will show how to select the best technology and format combination to develop a compliant immunogenicity binding method, and provide a check-list that itemizes all the requirements to develop a compliant validation protocol. Why Should You Attend: The principal components of a meaningful immunogenicity program consist of an initial binding screen followed by confirmation and quantitation of the positive samples. This 90-minute webinar first reviews the technologies and formats currently in use to detect unwanted immunogenicity. These sections will help the scientist to a priori select the appropriate procedures to specifically meet the needs of their product. The second part of the webinar provides a step by step approach to develop a method that will meet the current validation standards regardless of the technology and format that is utilized. Case studies are cited throughout the webinar to demonstrate the impact of the method on immunogenicity results. Finally, a check-list is supplied to ensure that essential requirements are in place to proceed into validation. Learning Objectives: Learn how to select the best technology and format combination to develop a compliant immunogenicity binding method. Start: 07/26/2012 10:00 am
End: 07/26/2012 11:30 am
This 90-minute webinar will review the new and proposed HIPAA Privacy and Security regulations and discuss their effects on the use of Electronic Health Records (EHRs). Why Should You Attend: Many of the new changes to HIPAA focus directly on a number of aspects of the use of electronic records, such as the accounting of disclosures and tracking of accesses of records of all kinds, even for treatment, payment, and healthcare operations, and the provision of records in electronic formats when requested. These proposed rules have a tremendous impact on not only EHRs, but also any electronic systems that hold protected health information in the designated record set. In this 90-minute webinar we will review the new and expected regulations and discuss their effects on the use of EHRs. We will show what policies need to be changed and how, discuss how disclosures must be tracked in an EHR, review the various ways patient records can be supplied electronically, discuss the requirements for meeting the mandatory Privacy and Security Objective in the Meaningful Use regulations (including requirements for a HIPAA Security Risk Analysis), and show what policies and evidence you need to produce if you are audited by the HHS Office of Civil Rights. The new enforcement penalty structure and the new program for random audits by HHS OCR will also be described. Agenda:
Start: 07/26/2012 11:00 am
Many marketers have differing opinions on marketing strategy. When is the right time to employ outbound tactics vs. inbound? When does a content strategy make sense vs. product focused messaging? There are marketers who regularly purchase marketing lists to amp up their program performance and others who choose not to. If you decide to utilize a targeted list, what's next? You need to be able to capitalize on this list and maximize the ROI. So how is a marketer to know what is right for them? In this live, interactive event, Net Prospex VP of Marketing Maribeth Ross will provide food for thought on deciding the right time to use a marketing list. LeadFormix's Enablement Manager, Mike Sasaki, will show you how you can get the most from a list using marketing automation basics to boost the number of qualified leads passed on to your sales team. We'll discuss: Date & Time- About LeadFormix Start: 07/26/2012 12:09 pm
Course Description: Understanding GLP regulations and requirement and achieving GLP compliance can significantly expedite the regulatory processes, bringing innovative medical products to the market faster and saving enormous amount of your unnecessary time, efforts and investment. During this interactive workshop, Dr. David Lim (Regulatory Doctor) will walk you through the relevant and applicable US regulations, regulatory requirements and guidance necessary for good laboratory practice (GLP) and GLP compliance. This workshop is intended to provide guidance on GLPs for conducting nonclinical laboratory studies that support or are intended to support applications for research or marketing permits for pharmaceutical and medical device products for human use regulated by the United States Food and Drug Administration (US FDA). During this workshop (2nd day), group discussions on implementing GLPs will be engaged. Areas Covered: The following areas will be discussed during this workshop: * US FDA GLP regulations and requirements Start: 07/26/2012 2:00 pm
End: 07/26/2012 3:00 pm
In this interactive Webinar, you will learn various tactics that can be used to significantly increase your online presence and build new business. How to use PPC Pay Per Click advertising You'll learn how to get in front of people who are actively seeking your products and services Hosts: HostAndrew Patricio | ||
