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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: 08/02/2012 10:00 am
Overview: To satisfy QSR and ISO 13485 requirements, medical device companies must respond to field reports swiftly and compliantly. There are certain circumstances in which a report from the field requires the device manufacturer to take steps regarding product in the field. It is critical that the company take the required steps in the required timeframes. FDA and ISO requirements overlap to a great extent, but not completely. This webinar sets forth the requirements for recalls, removals, and market corrections, and provides recommended practices. Why should you attend: There are certain circumstances in which a report from the field requires the device manufacturer to take steps regarding product in the field. It is critical that the company take the required steps in the required timeframes. If not, FDA's sanctions could be so onerous as to result in the company's inability to ship product. Areas Covered in the Session: Who Will Benefit: This webinar will provide valuable assistance to all regulated companies, since personnel training is a regulatory requirement in the Medical Device field. The employees who will benefit include: Jeff Kasoff, RAC, is the Director of Quality at Byrne Medical, a leading manufacturer of endoscopy and colonoscopy devices, where he oversees the operation of the quality system. In this position, Jeff is responsible for oversight of the document control system, including maintenance of regulatory documentation. Prior to this, Jeff spent 13 years at Life-Tech, Inc. as the Director of Regulatory Affairs, where he was responsible for compliance of the corporate quality system. Jeff received his regulatory affairs certification in 1996. Price List: Phone: 800-447-9407 webinars@globalcompliancepanel.com Start: 08/02/2012 10:00 am
Overview: Cleaning validation is increasingly important in preventing cross contamination and interactions between active ingredients in subsequent batches run in the same equipment. This webinar will review principles of sterilization validation and using them as a benchmark for more robust cleaning validation. Emphasis will also be placed on interrelationships with other processes and using the information gained during validation to monitor and control the cleaning process to prevent failure. Areas Covered in the Session: Who Will Benefit: This webinar will benefit any organization that wants to validate and improve the effectiveness of their cleaning processes. Those who will benefit include QA and Manufacturing Managers and Engineers who are responsible for validating cleaning or sterilization processes, Consultants, Auditors and responsible executives. Tony has BS degrees in Biology & Microbiology and a MS in Quality Management. He is currently Quality Manager at Sealed Air, a supplier of rigid medical device packaging solutions. Previously he was Quality Systems Manager at Davol, Director of Quality Assurance at Scott Laboratories and Sr. Microbiologist at the National Cancer Institute. He is a Certified Quality Auditor-BioMedical and Certified Manager of Quality and Organizational Excellence by the American Society for Quality. He also teaches the refresher courses for these certification programs through the local RI-ASQ section. Tony has over 20 years experience using quality management techniques and value added auditing including the use of Failure Investigation and Root Cause Analysis to improve processes and products Price List: Phone: 800-447-9407 webinars@globalcompliancepanel.com Start: 08/02/2012 10:00 am
Overview: Ensuring GCP quality has often been approached from the perspective of reviewing as many documents as possible, looking for errors and following up on corrections or making "notes to file." In order to design, implement, and maintain GCP compliance in an effective manner, a Quality Systems Approach should be adopted. In the GMP and GLP domains, this approach has led to more effective and efficient maintenance of compliance, since only by implementing effective systems can quality and compliance be established, monitored, and then maintained. Your speaker will describe the GMP Quality System, and how, in a similar manner, a GCP Quality System can be utilized by ensuring the proper establishment of investigator oversight and documentation; IRB oversight; sponsor monitoring; corrective and preventive action (CAPA) execution; IP controls; Clinical Staff and lab qualification. Your speaker will discuss each sub system in detail, why it exists, and how working together, they protect patient safety, rights, and welfare. Your speaker will present proposals for adopting this approach at clinical sites, as well as the role of the sponsor in establishing internal GCP quality systems, and ensuring compliance at the sites and CROs. The topic of auditing from a Quality Systems-Based Approach will also be discussed. Your speaker will also address why it is difficult to get clinical sites to use a "systems" approach and will give real-life examples of failures to deploy and implement these systems properly based on recent warning letters from FDA. Why Should You Attend: Many GCP compliance programs focus too much on and "audit and correct" approach. FDA takes a systems base approach towards compliance and implementation of such an approach by the Sponsor, the CRO, and the Clinical Site increases the likelihood of maintaining an acceptable level of compliance. In this webinar you will learn to see GCP compliance as an interaction of several sub-systems the work together to ensure patient safety and ethical treatment. Areas Covered in the Seminar: Who Will Benefit: Amnon Eylath is Director of Quality at Ariad in Cambridge, Massachusetts. He is responsible for global oversight of the QA/QC aspects of Drug Substance and Drug Product Manufacturing, Testing, Stability, Packaging and Distribution, as well as oversight of compliance for Pre-Clinical (GLP) and Clinical (GCP) Studies. Amnon has over 20 years of experience in medical research, process & method development, device development, facility/process design and validation, GxP audits and regulatory compliance, CMC support, development and deployment of quality systems, as well as disposition of Biotech and Small Molecule clinical materials for US and international use. Amnon is currently is leading the development of a technical report on the application of cGMP and Quality Systems for the complete development life-cycle of Biotech Drug Substance, in collaboration with industry and regulatory agency representatives. He is also a core member of industry Task Forces developing technical reports for application of GMPs to Investigational Medicinal Product, Development of Specifications for Early Phase drug development and Risk-Based auditing. He has recently commented to changes in Eudralex regulations covering drug development. He has also lectured at Moorpark College, UC Davis and Indiana University on Quality and Pharmaceutical Technology subjects, and was instrumental in the establishment of the Biotechnology certification and degree programs (respectively) at Moorpark College and Indiana University.' Price List: Phone: 800-447-9407 webinars@globalcompliancepanel.com Start: 08/02/2012 10:00 am
Overview: This live webinar concentrates on proper cleanroom cleaning, and discusses tools, equipment, agents, personnel training, extent, and frequencies. It is a very practical training session intended to assist personnel involved in the design, cleaning, monitoring, and assessment of cleanroom cleaning procedures. The key benefits of this course are: 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: 08/02/2012 2:00 pm
End: 08/02/2012 2:00 pm
A little public relations savvy can get you valuable media coverage. Coverage that has more impact than any advert you can buy. Attend this webinar to learn: The power of no cost publicity and how to get it. | ||
