Events
| Wed | ||
|---|---|---|
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: 08/01/2012 10:00 am
Overview: Medical device firms need to be aware of the benefits of compliance as well as the dangers of inadequate complaint handling. This Webinar will explain the regulatory process and in understandable terms. Many medical device firms face regulatory issues as a result of inadequate complaint handling. FDA has explicit complaint handling requirements and poor complaint & reporting procedures often result in costly recalls and warning letters. FDA warning letters and recalls are posted on FDA's website and published in trade magazines, newspapers available to firm's competitors, and has even driven the firm's stocks down. This presentation will review the regulations and point out some of the pitfalls in complaint handling and reporting. Areas Covered in the Session: Who Will Benefit: Some employees who wish to gain a better understanding include: John Chapman, BS, MBA, RAC has over 30 years medical device regulatory experience and over 10 years experience with the European Union's medical device directive, 93/42/EEC. John has led two device companies to ISO quality system certification and CE marking. He has been performed regulatory due diligence on over a dozen acquisitions in the past 12 years, exposing him to numerous quality systems, including consent decrees as well as many notified bodies. He earned his regulatory affairs certification (RAC) in 1998 and was a contributing author to 2004 Fundamentals of EU Regulatory Affairs, RAPS, 2004. He co-founded a local RAPS chapter and has been a speaker at these meetings and the annual RAPS conference. Price List: Phone: 800-447-9407 webinars@globalcompliancepanel.com Start: 08/01/2012 10:00 am
Overview: This webinar will review the different types of master regulatory files necessary for demonstration of compliance with GXP procedures, providing the regulatory authorities with appropriate data, and maintaining a well organized source/support documentation. Each submission to the FDA and any other regulatory entity is carefully prepared to present information from primary and secondary sources. The information in any submission needs to be able to be tracked all the way forward to the market application but also backwards to the raw data and indication that it was collected under GXP procedures. Proper organization and tracking of the regulatory files and their associated source documents can save companies thousands in time during the organization of any submission. The presentation will include descriptions of organization of the different regulatory communications and submissions, with appropriate tracking of key regulatory development dates to assure that submission are presented on time. In addition development of a tracking document for support nonclinical studies and GMP documents will be recommended. Compilation of regulatory meeting minutes generated internally and from the regulators will be briefly discussed. The organization of the Trial Master Files will be defined. Additional descriptions of the 5 types of Drug Master Files and Veterinary Master Files and their utility will be describedQuality assurance audits of regulatory files should be able to trace all data back to the original data and should be able to do so schematically. Document mapping methods will be discussed as useful tools that help assure the regulatory department has the necessary information. Areas Covered in the Session: Who will benefit: This webinar will provide valuable assistance and procedures for sponsors, regulatory departments, consultants project managers, clinical trial managers, CROs, CMOs, and clinical trial vendors (central labs, drug supply imaging service companies). Dr. McLane has over 25 years of progressive experience in all phases of global development with both large and small pharmaceutical companies. His knowledge basis has lead full development projects with over 50 clinical and medical device programs and to successful INDs, IDEs, NDAs and EMEA/CTA applications. Key strengths include the early development of clinical and regulatory strategies, risk management and identification, and negotiating with regulatory officials. Additional development activities include developing business rationale, teams, programs, and strategies for early clinical and combination product candidates in metabolic diseases, respiratory and oncology areas. He has also successfully completed in- and out-licensing reviews and negotiations including those for orphan indications and in vitro diagnostics. He possesses particular expertise in the initial formation and development of new start-ups and early clinical companies and has provided major contributions to business plans and presentations to venture capitalists for significant fund-raising. Dr. McLane has been leading recent regulatory and clinical services for clients in the various therapeutic areas at Clinquest. Price List: Phone: 800-447-9407 webinars@globalcompliancepanel.com Start: 08/01/2012 10:00 am
Overview: Water system validation is often considered a necessary evil intended to merely satisfy a regulatory expectation. If done using a one-size-fits-all template, it probably satisfies regulatory requirements but is indeed a waste of time when it could be a valuable "insurance policy". All water systems are different and have different challenges in consistently purifying and delivering acceptable water to users. Therefore, the validation details used for every water system should probably be unique, making a standard template convenient, but inappropriate. Using a little common sense and knowledge of how the water system works and is maintained, the thoughtful validation of a water system can be very worthwhile. This presentation will cover the basic ground rules you should have in place before embarking on water system validation, how that validation should be customized to your particular water system design and maintenance practices, what operational elements should be included in the validation based on potential impact, what happens when the "honeymoon" is over and the system ages, and at what point is validation finally over. Because of water system and validation costs, packaged water options are sometimes considered, but additional costly issues for packaged waters may not have been considered, as will be discussed. Also discussed will be lab water systems that may have special validation needs different from production's water systems. Why Should You Attend: Are you sure your water system was properly validated? Have you ever had chemical or microbial control problems with the water system that did not show up during validation? Have those problems ever caused manufacturing interruptions? Have those problems ever caused product problems? Are you absolutely sure? Though FDA is often glad to see that any sort of water system validation has been done, they will quickly raise their expectations (and "483 pad") if your validation was poorly done and resulted in product/health problems. You can avoid this regulatory attention as well as these product problems by applying a little logic to your validation protocol and avoiding standard templates which may not be the right challenge for YOUR water system. However, to apply logic, you MUST understand how your water system is intended to work and what could make it fail to do so. With every water system being different, a customized validation protocol is a necessity. Attending this presentation will allow you to understand what water system features are essential to include in validation (and which are not), and will also explore the validation needs of laboratory water systems as well as issues related to supposedly cost-avoiding options like using package waters. Areas Covered in the Session: Who Will Benefit: This webinar will be valuable for all companies that operate non-compendial deionized water systems as well as WFI or Purified Water systems, particularly for those in FDA and EMA regulated industries, including Medical Devices, Diagnostics, Pharmaceutical APIs and Dosage Forms, Biologics, consumer products, and cosmetics companies. The specific job functions that will benefit include: T.C. Soli, is a Ph.D. Microbiologist and President of Soli Pharma Solutions, Inc. (www.solipharmasol.com), and since becoming a full time consultant, has served consumer products and FDA-regulated industries with training and troubleshooting expertise covering water systems, sterilization, aseptic processing, microbiological and beta-lactam contamination control, microbiological laboratory operations, and has served as a pharmaceutical expert witness in several "contamination" litigations. Prior to full time consulting, he had 25 years of diverse "Big Pharma" operating company experience. During his 31+ year career he has lectured extensively at conferences, authored numerous papers and recently written several book chapters related to water system microbiology for USP, PDA and ISPE publications. He is currently serving in his third five-year term on USP Expert Committees responsible for Pharmaceutical Waters through which he authored the complete rewrite of USP Chapter <1231> which many consider to be USP's "pharmaceutical water bible". Price List: Phone: 800-447-9407 webinars@globalcompliancepanel.com Start: 08/01/2012 11:00 am
Every week there is an announcement about the formation of yet another Accountable Care Organization (ACO). It is reported that over 160 ACOs are in development right now – a sign that the healthcare industry is committed to improving the experience of care and the health of the population while reducing the cost of care. So where do you stand? Are you ready to become an ACO? Are you able to determine which hospital units have the highest rate of unplanned re-admissions and then work to reduce them? Can you decrease the number of adverse events? • Identifying and optimizing your patient base by performing patient panel analytics Join us for a round table discussion on Wednesday, August 1, 2012 and hear firsthand how other healthcare organizations are making this journey. | ||
