BEGIN:VCALENDAR VERSION:2.0 PRODID:-//Ensemble Independent//vPim 0.695//EN CALSCALE:Gregorian X-WR-CALNAME:Boxes and Arrows Events Calendar BEGIN:VEVENT DTSTART;VALUE=DATE:20120209 DTEND;VALUE=DATE:20120210 SUMMARY:Make a Great Impression - In Print and In Person LOCATION:Wilmington\, Delaware\, USA DESCRIPTION:Overview : But here's the thing - Even if you learn all the pre sentation skills taught since Demosthenes first yelled at the ocean through a mouthful of marbles\, even if you memorize Strunk and White's "Elements of Style\," there is one factor that can negatively impact your presentatio n - the fear of not making a good impression. When we are worried about how we are coming across\, we are unable to access the most important element of making a good impression\, namely convincing our "audience" that we care more about them than about ourselves! \nWhether you are flying solo or lea ding a team of presenters\, Terry will show you how to: \n \n Connect wi th your authentic self\, and create a strong presence that your audience or reader can’t resist. \n Recognize and transform limiting beliefs that o perate "under the surface" and contribute to fear \n Manage your fear an d transform the energy into positive power and the ability to create an enj oyable experience for you and your audience! \n Access the "Power of Int ention" as a foundation for your actions \n Clarify your message\, focus ing on the "so what" for your audience \n Develop simple support materia ls that enhance rather than detract from your presentation \n \nAreas Cover ed In the Session: \n \n Connect with your authentic self and create s s trong message that your audience or reader can't resist \n Recognize and transform limiting beliefs that operate "under the surface and contrib ute to fear \n Manage your fear and transform the energy into positi ve power and the ability to create an enjoyable experience for you and your audience \n Access the "Power of Intention" as a foundation for you r actions \n Clarify your message\, focusing on the "so what" for your a udience \n Develop simple support materials that enhance rather than detract from your presentation \n \nWho will benefit: \n \n Entrepreneu rs \n Sales Managers \n Sales Executives \n Business Development M anagers and Staff \n END:VEVENT BEGIN:VEVENT DTSTART;VALUE=DATE:20120210 DTEND;VALUE=DATE:20120211 SUMMARY:Managing OSHA Inspections and Investigations LOCATION:Palo Alto\, California\, USA DESCRIPTION:Why Should You Attend: \n \nPerhaps of all of the interactions that occur with regulatory agencies\, the unannounced OSHA inspection is th e most stressful\, and least understood by business owners. The key to mana ging a surprise OSHA Inspection or a letter of complaint directed at your c ompany is to understand what the process is and what the OSHA inspectors ar e looking for. \n \nThis presentation will explain what the process is for an OSHA inspection\, and how to respond to a letter of complaint. Also\, th is presentation will explain what inspectors are looking for\, how employee s and unions figure into the inspection equation \, and what you must do to expedite the inspection and help resolve issues before they become major p roblems. \n \nThis session will help business owners and safety personnel h ave a better understanding and feel more in control of the situation when O SHA inspectors arrive at your site\, especially if they arrive unannounced. END:VEVENT BEGIN:VEVENT DTSTART;VALUE=DATE:20120214 DTEND;VALUE=DATE:20120215 SUMMARY:FDA’s Thinking for Industry cGMPs for Phase 1 INDs LOCATION:Palo Alto\, United States DESCRIPTION:The US FDA has issued a draft guidance document outlining a sug gested approach to complying with current good manufacturing practice (CGMP ) requirements for drugs intended soley in Phase 1 studies.With this guidan ce and an accompanying regulation\, US FDA formally recognizes specific sta ndards for the manufacture of small amounts of drug products for phase 1 st udies and formulating an approach to cGMP compliance that is appropriate fo r the particular stage of drug development. This presentation will give an insiders insight into the the new guidance and regulation and discuss the r ationale for such. END:VEVENT BEGIN:VEVENT DTSTART;VALUE=DATE:20120215 DTEND;VALUE=DATE:20120216 SUMMARY:BostonCHI Feb 15 2012-Mark Schifferli on data viz LOCATION:Waltham\, Massachusetts\, USA DESCRIPTION:How do you design interactions that make a user able to navigat e\, understand\, and appreciate their data? \n \nData visualization has eme rged as a primary technique for understanding large datasets. The past deca de's surge of available data inspires much discussion about visualization t echniques. The discussion tends to focus on a visual language for static pr esentation\, but rarely addresses the range of interactions that are possib le in a digital environment. \n \nMark Schifferli of Fathom Information Des ign will show examples of how interaction techniques can further push an au dience’s understanding of a complex data set. \n END:VEVENT BEGIN:VEVENT DTSTART;VALUE=DATE:20120215 DTEND;VALUE=DATE:20120216 SUMMARY:CRO or ARO: How to Hire and Manage One LOCATION:Palo Alto\, California\, USA DESCRIPTION:Why Should You Attend: \n \nA critical component in successful Clinical Research Trials is ensuring that you choose the right CRO/AOR base d on the phase of the trial\, the therapeutic area and the countries that t he trials will be conducted. It is then important that the scope of the wor k be clearly defined to ensure that budget and timelines are respected and that the data collected will stand up to regulatory scrutiny. This protects both the CRO/ARO and the sponsor company. It also makes the job of the Pro ject Managers on both sides easier. \n \nThis presentation will show how y ou can manage the CRO/ARO in this environment of multi-center\, multi-count ry trials. We will discuss how you can ensure that you comply with regulati ons in the various countries from shipping drug to ensuring that the inclus ion criteria are well understood in all countries and that the appropriate patients are enrolled. Diagnostic criteria are not always interpreted in th e same manner. This is particularly true in some therapeutic areas such as CNS. We will also review the current trend towards enrolling pediatric pati ents as well as elderly and more vulnerable populations\, and the challenge s that go with it\, in the various environments that studies are conducted. END:VEVENT BEGIN:VEVENT DTSTART;VALUE=DATE:20120215 DTEND;VALUE=DATE:20120216 SUMMARY:Payroll Best Practices: How to Deal with the IRS LOCATION:Wilmington\, Delaware\, USA DESCRIPTION:Overview : What do you do when they contact you? Panic\, Procra stination\, Belligerence and Ignorance are big mistakes! The IRS takes a va riety of steps to combat employment tax non-compliance\, with the upshot be ing significant criminal penalties and convictions resulting in incarcerati on\, heavy fines\, or usually both. Whether there is a violation or not\, a ll of those steps begin with written and oral communication to the entities involved. Proper courtesy goes a long way to make your experience easier b ut more than that is needed to ensure successful communication. \n \nWhy yo u should attend: Attend this webinar to understand how to communicate more effectively with the IRS and other regulatory agencies. Use of the informat ion and strategies presented can significantly reduce anxiety\, provide Add ed clarity in response to official communications and in some cases help pr event simple issues from escalating to serious situations. \n \nAreas Cover ed In the Session: In this webinar you will learn: \n \n How to determin e what is - and is not - an IRS notice \n Step by step instructions on h ow to respond to an IRS notice \n Dos and don'ts of corresponding with t he IRS or any government agency \n Tips on preparing for an audit \n Best practices for payroll departments to avoid audits \n How to beat th em to it - strategies to conduct your own internal audit \n \nWho will bene fit: \n \n Payroll professionals \n Human Resources \n Accounting Personnel \n Business Owners \n Lawmakers \n Attorneys \n Any i ndividual or entity that must deal with the complexities and technicalities of the payroll process END:VEVENT BEGIN:VEVENT DTSTART;VALUE=DATE:20120216 DTEND;VALUE=DATE:20120217 SUMMARY: Independent Contractors in Today's Economy LOCATION:Wilmington\, Delaware\, USA DESCRIPTION:Most businesses use a combination of employees and contractors to fulfill different business needs. That makes sense but it's important to recognize that employees and contractors have different rights\, and busin esses have different obligations to each of them. To comply with those obli gations\, you should be familiar with the various independent contractor te sts used by different federal and state agencies and the courts so that you can make a sound business decision about how you classify your workers. \n \nWhy you should attend: Every business has to classify their workers as e mployees or independent contractors. When it comes to independent contracto r classifications\, the path is not always clear and if you get it wrong\, penalties are severe. So it's important to understand the tests that are us ed to determine contractor status and how to maintain that status once it's been established. Government agencies\, both federal and state\, have been stepping up their enforcement efforts and mechanisms for the past several years and particularly since 2009. \n \nAreas Covered In the Session: \n \ n The current compliance and enforcement environment when it comes to wo rker misclassifications \n Benefits and pitfalls of using independent co ntractors \n Understanding the various federal and state tests for prope r classification of independent contractors \n The scope of penalties fo r improper classification \n Information about recent classification law suits and investigations \n Best practices for entering into and maintai ning independent contractor relationships \n \n \nWho will benefit: \n \n Managers and supervisors \n Human Resources professionals (business pa rtners\, generalists and functional specialists) \n Payroll professional s \n Business Owners \n Administrators and office managers \n Cont ract Managers \n Compliance Professionals \n \n END:VEVENT BEGIN:VEVENT DTSTART;VALUE=DATE:20120216 DTEND;VALUE=DATE:20120217 SUMMARY:Compliance with FDA and ISO Regulations LOCATION:Palo Alto\, United States DESCRIPTION:Why You Should Attend: \n \nNegative customer feedback about a medical device's performance or safety is a strong indicator of whether a f irm's manufacturing process is in control. This feedback is therefore subje ct to many requirements in both the QSR and ISO 13485. Failure to follow up on complaints about medical devices is among the most frequently cited obs ervations on FDA-483s. This session will include the requirements for defin ing\, documenting\, and implementing a complaint-handling system\, includin g the requirements for complaint review\, investigation\, and corrective ac tion\, as well as the ISO-specific implications. END:VEVENT BEGIN:VEVENT DTSTART;VALUE=DATE:20120216 DTEND;VALUE=DATE:20120217 SUMMARY:Social Media and Marketing FDA Regulated Products LOCATION:Palo Alto\, California\, USA DESCRIPTION:Why Should You Attend: \n \nThe FDA recently held hearings addr essing drug companies' use of social media and other online platforms to ad vertise. FDA also released a guidance document about manufacturers’ obligat ion regarding off-label information available about their products. Another guidance document about use of social media in marketing is expected soon. In addition\, FDA issued several letters to manufacturers indicating the r ules for using social media. \n \nBut there is still much confusion among F DA regulated companies how to use social media for marketing effectively an d still be compliant with regulations. How can medical device\, pharmaceuti cal and other FDA regulated industries use social media channels like Faceb ook\, Twitter\, YouTube and LinkedIn to get their message out in a way that is compliant with advertising and promotion regulations found in the Food Drug & Cosmetic Act? This 60-minute webinar will present ways to use social media that are compliant with FDA regulations. Practical regulatory strate gies will be suggested to ensure compliance and balanced social media activ ity. END:VEVENT BEGIN:VEVENT DTSTART;VALUE=DATE:20120217 DTEND;VALUE=DATE:20120218 SUMMARY:HIPAA Privacy and Security Audits and Enforcement LOCATION:Palo Alto\, United States DESCRIPTION:Why Should You Attend: \n \nThe new HIPAA compliance audit prog ram has been announced and is now under way\, bringing HIPAA compliance aud its to up to 150 HIPAA Covered Entities by the end of 2012. If your organiz ation is not ready\, the HIPAA rules have new\, significantly higher fines\ , including mandatory minimum fines of $10\,000 for willful neglect of comp liance. \n \nIn this session we will discuss the HIPAA audit and enforcemen t processes and how they apply to covered entities and business associates. We will explain the enforcement regulations and their recent changes. We w ill discuss what information and documentation needs to be prepared in adva nce so that you can be ready for an audit without notice. Sample informatio n request forms and questions asked at prior audits will be presented. The session will also cover how to know if you may become the subject of an aud it or enforcement action\, and what you can do to help limit your exposure. We will discuss how most enforcement actions come about and what can be do ne to prevent incidents that lead to enforcement. END:VEVENT BEGIN:VEVENT DTSTART;VALUE=DATE:20120217 DTEND;VALUE=DATE:20120218 SUMMARY:OSHA Asbestos and Mold Awareness LOCATION:Palo Alto\, California\, USA DESCRIPTION:Why Should You Attend: \n \nAsbestos is one of the most highly regulated substances\, and for good reasons as it’s a potent carcinogen wit h no known safe exposure. Of all of the toxic and hazardous substances it c ould have regulated\, OSHA chose to regulate Asbestos first. \n \nMold\, on the other hand\, is an even more ubiquitous contaminant in buildings\, yet OSHA has not even attempted any regulations specific to it. Instead\, they have a set of guidelines as well as several general regulations that all a pply. \n \nIn this 3-hour session we will cover the required elements of th e 2-hour awareness training OSHA requires for Asbestos\, as well as the OSH A Mold guidelines and many of their applicable regulations. \n \nLearning O bjectives: \n \nAt the end of the training\, learners should be able to: \n \n - Describe what Asbestos is and its various forms. \n - Explain the adv erse health effects of asbestos. \n - List the different steps to avoid exp osures to Asbestos. \n - Delineate the general OSHA requirements for Asbest os. \n - List the various OSHA regulations that apply to Mold. END:VEVENT BEGIN:VEVENT DTSTART;VALUE=DATE:20120221 DTEND;VALUE=DATE:20120222 SUMMARY:Device History Records and Technical Files LOCATION:Palo Alto\, United States DESCRIPTION:Why Should You Attend: \n \nGlobal companies must meet differen t product design documentation for the U.S. and the European Union / Common Market. The cGMPs mandate Design Control and the Design History File (DHF ). In order to sell globally\, the EU's CE-marking documentation is a requ irement -- the Technical File or Design Dossier. Currently they serve diff erent purposes\, support different goals\, but the TF/DD is moving in the d irection of the DHF. And the DHF may soon borrow some features required in the TF/DD. Being aware of the similarities and differences can further con current development / documentation\, and/or updates to both. What are DMR s and DHRs relationship to DHFs\, TF/DDs? END:VEVENT BEGIN:VEVENT DTSTART;VALUE=DATE:20120222 DTEND;VALUE=DATE:20120223 SUMMARY:Implementation of Pharmacogenomics into Clinical LOCATION:Palo Alto\, California\, USA DESCRIPTION:Why Should You Attend: \n \nThe FDA's Center for Drug Education and Research has relabeled many drugs recommending pharmacogenomic testing . In other cases\, the FDA has issued "black box" warnings cautioning docto rs that there are genetic variances that effect safety profile for drugs su ch as codeine and clopidogrel. These FDA mandates have driven the adoption of pharmacogenomic testing into clinical practice to date. \nPharmacogenomi c laboratory tests are available for these drugs.Adverse events caused by t hese drugs may lead to medical malpractices should there be a failure to ac count for these variances. \n \nPersonalized medicine involves providing th e right drug for the right patient at the right time. Drug dosing regimens for medications in routine clinical practice are established for the majori ty of individuals (wildtype). Unfortunately\, individuals with genetic vari ances in genes that encode drug metabolizing or transport enzymes who are g iven standard dosages can result in poor drug efficacy or significant toxic ity. Clinical pharmacogenetic testing is a means for personalizing medicine . \n \nThis 90-minute presentation will cover the basic principles of pharm acogenomics and pharmacogenetics and will discuss in detail the steps behin d implementing a clinical pharmacotenomic testing service. END:VEVENT BEGIN:VEVENT DTSTART;VALUE=DATE:20120223 DTEND;VALUE=DATE:20120224 SUMMARY:Accelerating Bioassay Transfer in a GMP Environmen LOCATION:Palo Alto\, United States DESCRIPTION:Why Should You Attend: \n \n50% of the drugs presently in disco very are biopharmaceuticals - these numbers lead to an "outsource or perish " philosophy for GMP/GLP development\, validation and sample analysis. Unli ke synthetic drugs requiring only straightforward analytical testing biopha rmaceuticals require more elaborate assays to attain regulatory compliance. The industry has a significant underestimation of the discipline\; skills and planning required to successfully transferring these assays. Naiveté in this area causes loss of precious time and money during development. \n \n Participants in this seminar will attain a valuable checklist of critical i nformation that will reduce delay and confusion during method transfer. The hands-on\, common sense approach will provide a chronological pathway that can easily be adapted for any complex assay. END:VEVENT BEGIN:VEVENT DTSTART;VALUE=DATE:20120223 DTEND;VALUE=DATE:20120224 SUMMARY:Documentation for Sterilization Process Validation LOCATION:Palo Alto\, United States DESCRIPTION:Why Should You Attend: \n \nHaving a plan for gathering and com piling appropriate sterility assurance documentation to be included in a gl obal marketing application is essential for injectable drug products. In th is session we will provide an overview of current regulatory guidance and c ompendial requirements associated with sterilization validation and control of microbial quality. We will review what information is needed\, what lev el of detail is included\, and how to present the documentation in CTD form at. \n \nAttendees will also learn what data and information need to be inc luded in your submission for different approaches (terminal sterilization v s. aseptic processes) to manufacturing a sterile drug product. We will revi ew information needed in support of the sterilization and depyrogenation of container closure components\, filter validation\, heat penetration and di stribution studies\, and container closure integrity testing. END:VEVENT BEGIN:VEVENT DTSTART;VALUE=DATE:20120223 DTEND;VALUE=DATE:20120224 SUMMARY:Japan Regulatory and Clinical Trial Requirements LOCATION:Palo Alto\, United States DESCRIPTION:Why Should You Attend: \n \nThis 6 hour virtual seminar will he lp you gain a comprehensive understanding of the Regulatory Structure\, Cli nical Trial Requirements and the Conduct of Running Clinical Research in Ja pan. It will prepare you for the regulatory approval processes\, Agency mee tings\, the complexities of running studies in Japan\, the importance of pa rtner selection and add the cultural knowledge needed for success. The rece nt changes made by PMDA to be more sponsor-friendly will be reviewed. Real world experiences on actual interactions with the Agency since these change s\, will also be discussed. END:VEVENT BEGIN:VEVENT DTSTART;VALUE=DATE:20120223 DTEND;VALUE=DATE:20120224 SUMMARY:Understanding Design Controls for Medical Devices LOCATION:Palo Alto\, United States DESCRIPTION:Why You Should Attend: \n \nPrior to introduction of a new devi ce\, or even a modified design for an existing device\, a systematic proces s must be followed. This process must ensure that all requirements are met. A firm's design control process must meet all regulatory requirements\, bu t at the same time not be as unwieldy as the present a barrier to timely ma rket introduction. This webinar will cover the basics of design controls\, and provide recommendations for implementation of a compliant design contro l system. Also discussed will be design control requirements for devices al ready in distribution. Documentation requirements for each design stage wil l be included as well. END:VEVENT BEGIN:VEVENT DTSTART;VALUE=DATE:20120224 DTEND;VALUE=DATE:20120225 SUMMARY:Leaping into Lab: Everything about Waived Testing LOCATION:Palo Alto\, California\, USA DESCRIPTION:Why Should You Attend: \nWaived testing is an exciting way to leap into the world of laboratory testing. With over a hundred tests to cho ose from\, every speciality can find testing that will benefit the patients . We will explore the process to become a Waived lab and the many benefits of doing so. We will look at the rules and regulations set forth by CLIA un der CMS and how to best meet them. We also will explore the many tests avai lable and how they can benefit your patients. Waived labs make up the major ity of laboratory testing taking place in this country and more tests are b eing added to the Waived category all the time. With less regulatory oversi ght\, ease of use and great re-imbursement\, Waived testing is hard to beat . We will also look at the future of Waived testing and where it is headed. \n \nAreas Covered in the seminar: \n \n - Waived testing history and orig ins. \n - Waived testing CLIA rules and regulations. \n - Waived tests avai lable and how they fit into your practice. \n - How to apply for Waived tes ting and the State's role. \n - The future of Waived testing and how it aff ects you \n - Waived testing pitfalls to avoid. END:VEVENT BEGIN:VEVENT DTSTART;VALUE=DATE:20120228 DTEND;VALUE=DATE:20120229 SUMMARY:Defending Against an OFAC Investigation LOCATION:Palo Alto\, California\, USA DESCRIPTION:Why Should You Attend: \n \nThe U.S. government takes violation s of economic sanctions prohibitions very seriously. Just recently\, JP Mor gan Chase had to pay $88.3 million to settle allegations that it had violat ed a number of OFAC administered sanctions prohibitions. This type of penal ty is not abnormal as for most sanctions violations OFAC can administered p enalties of up to $250\,000 USD or twice the value of the transaction\, per transaction that violated the sanctions. As there is lack of information p ublically available many are lost when it comes down to how an OFAC investi gation and enforcement action should be handled. \n \nDefending against an investigation from the United States Department of the Treasury Office of F oreign Assets Control (OFAC) can be a stressful process. Careful navigation and understanding of this process is required to shield one’s self or comp any from massive penalties and reputational risk. \n \nThis webinar is desi gned to teach participants how to successfully navigate the OFAC enforcemen t process and reduce any OFAC penalties. END:VEVENT BEGIN:VEVENT DTSTART;VALUE=DATE:20120228 DTEND;VALUE=DATE:20120229 SUMMARY:Meeting FDA Requirements for Clinical Trials LOCATION:Palo Alto\, California\, USA DESCRIPTION:Why Should You Attend: \n \nClinical Project Managers need to h ave clear perspective of what may be needed for assuring compliance with FD A requirements of a given clinical trial at all times. Non-compliance with these requirements could lead to rejection of the trial data\, and even oth er more severe penalties. \n \nThis course will provide an overview of regu latory management for clinical trials. We would discuss the key regulatory aspects of a clinical project such as clinical protocol management\, IRB ma nagement\, safety reporting\, rules for recruitment programs\, seeking advi ce from FDA\, trial master files\, and training requirements. Practical tip s for regulatory management of a clinical trial project will be provided us ing case studies from the presenter’s personal experience. If you are aspir ing to be a clinical project manager\, are sponsoring a clinical trial\, su pervise clinical trial operations\, or would like to become a clinical site \, this course is a must for you. END:VEVENT BEGIN:VEVENT DTSTART;VALUE=DATE:20120229 DTEND;VALUE=DATE:20120301 SUMMARY:DMR & DHR - What Is Really Required LOCATION:Palo Alto\, United States DESCRIPTION:Why Should You Attend: \n \nHave you ever been confused about w hat needs to be in your Device Master Record (DMR) and your Device History Record (DHR)? This webinar will help you understand the requirements and as semble a complaint DMR and use it to build your DHR. \n \nThe webinar will also help you understand some very important related documents. The Design History File (DHF) is part of the design project\, and does not duplicate t he DMR. The webinar will help you understand the difference. In addition\, the Quality System Record (QSR) can be a valuable adjunct to the DMR. The s peaker will advise you on when to put device information into the QSR. END:VEVENT BEGIN:VEVENT DTSTART;VALUE=DATE:20120229 DTEND;VALUE=DATE:20120301 SUMMARY:Solutions to the Challenges of Phase I and FIM LOCATION:Palo Alto\, California\, USA DESCRIPTION:Why Should You Attend: \n \nAs need for more aggressive drug de velopment that still ensures the safety of the subjects and the drug itself becomes more and more important\, the challenges of those individuals resp onsible for the Phase I activities increase exponentially. To not meet thes e challenges has consequences. \n \nThe lines of distinction between the cl assical phases in the drug development are becoming more and more blurred\, and the challenges facing the Sponsor\, the Principal Investigator\, and t he sites are becoming increasingly important. No longer is the First-in-Man study only done on normal healthy volunteers or are protocols fixed lines in the sand that are not changeable until the study is completed. No longer is the New Chemical Entity (NCE) a simple chemical with almost predictable effects and we no longer see Phase I studies conducted only in confined Cl inical Pharmacology Units. All of these challenges make recruiting more cha llenging and Monitoring equally so. END:VEVENT BEGIN:VEVENT DTSTART;VALUE=DATE:20120301 DTEND;VALUE=DATE:20120302 SUMMARY:Understanding Attribute Acceptance Sampling LOCATION:Virtual DESCRIPTION:Why should you attend: Imagine this! Your company uses acceptan ce sampling in your manufacturing process and your manager asked to make su re it is cost effective. She also knows there is some risk associated with sampling\, but she admits she doesn’t completely understand it. You now hav e a new assignment\; assure your manager that you have good balance between risk and cost. The person who set up the system retired a few years ago an d isn’t available to help. You have also heard about some new methods calle d c=0 or zero based acceptance. \nHow do you know how much your inspection system costs? \nAre you inspecting too much\, and wasting money? \nAre you inspecting too little and incurring risk? \nDo your current managers and su pervisors understand how the system works? \nWill your ISO 9001 registrar a sk for justification of these statistical methods? \nShould you start to us e these c=0 plans you have heard about? \n \nWho Will Benefit: This seminar is designed for people in manufacturing who are involved in setting produc t specifications\, setting up acceptance plans\, performing acceptance acti vities\, and supply chain management. Attendees should have knowledge of ma nufacturing process that includes acceptance activities such as incoming\, in-process\, and final acceptance. This typically includes: \nQuality Engin eers \nProduction and Process Engineers \nManufacturing Engineers \nDesign Engineers \nPurchasing Managers \nPurchasing Agents \nSupplier Quality Engi neers \nQuality Supervisors \nQuality Inspectors \nQuality Managers \n \nPr ice List: \nLive : $245.00 \nCorporate live : $995.00 \nRecorded : $295.00 \n \nwebinars@globalcompliancepanel.com \nhttp://www.globalcompliancepanel .com \n \nPhone: 800-447-9407 \nFax: 302-288-6884 \n END:VEVENT BEGIN:VEVENT DTSTART;VALUE=DATE:20120301 DTEND;VALUE=DATE:20120302 SUMMARY:Verification vs. Validation in Regulated Industrie LOCATION:Virtual DESCRIPTION:Learn about the risks and complications involved with the appli cation of sound verification and validation principles. \n \nWhy Should Yo u Attend: The meanings and regulatory requirements of the terms "verificati on" and "validation" are often confusing to engineers and even some regulat ory professionals. FDA regulations as well as European standards such as IS O 13485:2003 require both verification & validation documentation throughou t these regulations and standards.The terms apply to design control\, proce ss control and others. Verification and validation also appear in the "esse ntial requirements" in MDD 93/42/EEC needed for CE marking medical devices in the European Union. Good engineering practices in all industries benefit from well executed verification and validation studies. \n \nAreas Covered in the Seminar: \nVerification & validation types \nDefinitions \nDesign c ontrol \nProcess control \nApplication \nConsequences of poor verification & validation \nWhy verification & validation makes good business sense \nWh o Will Benefit: Employees who will benefit include: \nQuality & Regulatory Professionals \nManufacturing & Design Engineers \nMarketing Product Manag ers \nCorporate & Operations Executives \n \n \nPrice List: \nLive : $245.0 0 \nCorporate live : $995.00 \nRecorded : $295.00 \n \nwebinars@globalcompl iancepanel.com \nhttp://www.globalcompliancepanel.com \n \nPhone: 800-447- 9407 \nFax: 302-288-6884 \n END:VEVENT BEGIN:VEVENT DTSTART;VALUE=DATE:20120303 DTEND;VALUE=DATE:20120304 SUMMARY:Agile UX 2012 LOCATION:Sydney\, Australia DESCRIPTION:Agile UX 2012 is a single day\, single track conference about d esigning great user experiences within an agile development process. \n \nI t’s not at all about how to do UX quicker or leaner. It’s not just about ho w to fit user research and usability testing into Agile\, or how to communi cate user needs. \n \nIt’s more than those – it’s about how great experienc es are designed and created within the structure of an agile development pr ocess. \n \nRegistration is open now. END:VEVENT BEGIN:VEVENT DTSTART;VALUE=DATE:20120304 DTEND;VALUE=DATE:20120306 SUMMARY:MX: Managing Experience 2012 LOCATION:San Francisco\, California\, USA DESCRIPTION:About This Event \n \nMX is a conference for people who take a leadership role in guiding better experiences into the world. Learn from re al-world examples and discover new approaches that can help you lead your o rganization toward investing in\, or improving your customer experience on the web\, mobile\, and beyond. \n \nSPEAKERS \nGenevieve Bell\, Intel Labs (Keynote) \nApril Showers\, United Airlines \nBrandon Schauer\, Adaptive Pa th \nChris Risdon\, Adaptive Path \nDane Howard\, eBay \nGreg Petroff\, GE \nIan Swinson\, Salesforce \nKevin Nolan\, Strategy Analytics \nKip Lee\, P hD Candidate @ Case Western Reserve University \nLaura Kirkwood-Datta\, Ada ptive Path \nLynne Waldera\, InMomentum \nMelissa Matross\, The Hotwire Gro up \nMiguel Lunaparra\, Sony \nNancy Dickensen\, Dickenson\, LLC \nPaula We llings\, Adaptive Path \nThor Muller\, Get Satisfaction \nVidya Drego\, For rester Research \n \nWORKSHOPS \nSarah B. Nelson\, Tapir & Tine \nRichard D alton\, Vangaurd \n \nTWITTER \n@mxconf END:VEVENT BEGIN:VEVENT DTSTART;VALUE=DATE:20120306 DTEND;VALUE=DATE:20120307 SUMMARY:21 CFR Part 11 and Annex 11 LOCATION:Virtual DESCRIPTION:Areas Covered in the Session: \nWhich data and systems are subj ect to the regulations? \nWhat the regulations mean\, not just what they sa y. \nAvoid 483 and Warning Letters. \nExamine the regulatory requirements f or the three primary areas of Part 11 compliance: SOPs\, software product f eatures\, and validation documentation. \nEnsure data integrity\, security\ , and protect intellectual property. \nUnderstand the current computer syst em industry standards for security\, data transfer\, and audit trails. \nEl ectronic signatures\, digital pens\, and biometric signatures. \nEvaluate t he regulatory requirements related to the current computer system standards for security\, data transfer\, audit trails\, electronic signatures\, digi tal pens\, and biometric signatures. \nSOPs required for the IT infrastruct ure. \nProduct features to look for when purchasing COTS software. \nReduce validation resources by using easy to understand fill-in-the-blank validat ion documents. \nWho Will Benefit: \nIT \nQA \nQC \nLaboratory staff \nMana gers \nGMP\, GCP\, GLP professionals \n \n \nPrice List: \nLive : $245.00 \ nCorporate live : $995.00 \nRecorded : $295.00 \n \nwebinars@globalcomplian cepanel.com \nhttp://www.globalcompliancepanel.com \n \nPhone: 800-447-940 7 \nFax: 302-288-6884 \n END:VEVENT BEGIN:VEVENT DTSTART;VALUE=DATE:20120306 DTEND;VALUE=DATE:20120307 SUMMARY:Audit/Inspection Preparedness for ClinicalResearch LOCATION:Palo Alto\, California\, USA DESCRIPTION:Why Should You Attend: \n \nThe Clinical Research Coordinator ( CRC) plays a key role in the site’s success at audits/inspections\, and mus t therefore know how to ensure the site is ready for an audit or inspection at all times. \n \nIn order to ensure audit/inspection preparedness\, the CRC must be aware of the applicable regulatory and sponsor requirements\, g uidelines and SOPs\, and ensure the conduct of the clinical research at the site complies with them. The site coordinator must know how to prepare for an audit or inspection and how to act and respond to questions during the audit or inspection. Following the audit or inspection\, the site coordinat or should be able to appropriately act upon the audit or inspection finding s. \n \nThis 60-minute presentation will detail the responsibilities of the Investigator and the clinical research coordinator during and after Site A udits/Inspections. We will discuss how you can prepare your clinical site f or audits/inspections and ensure readiness at all times. This webinar will provide valuable assistance to the Clinical Research Personnel in the Pharm aceutical\, Biotech and Medical Device industries. END:VEVENT BEGIN:VEVENT DTSTART;VALUE=DATE:20120306 DTEND;VALUE=DATE:20120307 SUMMARY:First-in-Human and Subsequent Phase I studies LOCATION:Virtual DESCRIPTION:Why you should attend: The lines of distinction between the cla ssical phases in the drug development are becoming more and more blurred\, and the challenges facing the Sponsor\, the Principal Investigator\, and th e sites are becoming increasingly important. These challenges must be known and appreciated \n \nAreas Covered In the Session: \nWhat is the roll of t he Investigators Brochure in the FiM process? \nWhat do you expect to learn from the FiM study? \nWhat are the factors in choosing the first does of a NCE \nThe challenge of developing an effective / efficient Phase I Program \nHow to recruit Study Participants in this new age of Social Media \nThe importance of accurately assessing and reporting Adverse Events \nThe impo rtance of Protocol knowledge in preventing errors \nHow to not miss "safety Assessments" when you do not know what to look for \nThe Setting up of a s ite that is prepared for First-in-man studies \nWho will benefit: \nPrincip al Investigators and sub investigators \nClinical Research Scientists \nRes earch Managers \nSafety Nurses \nClinical Research Associates (CRAs) and Co ordinators (CRCs) \nRecruiting Staff \nQA / QC auditors and staff \nStudy M onitors \nClinical Research Data managers \n \n \nPrice List: \nLive : $245 .00 \nCorporate live : $995.00 \nRecorded : $295.00 \n \nwebinars@globalcom pliancepanel.com \nhttp://www.globalcompliancepanel.com \n \nPhone: 800-44 7-9407 \nFax: 302-288-6884 \n END:VEVENT BEGIN:VEVENT DTSTART;VALUE=DATE:20120306 DTEND;VALUE=DATE:20120307 SUMMARY:Software Verification and Validation Planning LOCATION:Palo Alto\, California\, USA DESCRIPTION:Why Should You Attend: \n \nSoftware and related hardware desig n\, development\, verification and validation is difficult to manage\, docu ment and control. \n \nThis presentation focuses on the verification and va lidation planning and execution of software after basic developmental testi ng and de-bug. It includes COTS (commercial off-the-shelf) and growing "c loud"-based software. A suggested FDA model will be evaluated\, implemente d\, with V&V documentation and test case examples. \n \nThe focus will be o n the most recent issues the FDA has had in this area\, and remediation app roaches. Software considered include: 1) In-product\, 2) As-product\, 3) Pr oduction and test\, and 4) QMS / 21 CFR Pt. 11. Field examples\, good and bad will be addressed. Evaluation of the chief areas of FDA concerns will focus on actual and anticipated changes in emphasis based on the changing r egulatory climate. \n \nThis webinar will provide valuable assistance to al l regulated companies in evaluating their existing or anticipated software V&V activities and documentation requirements\, especially in light of the changes in the FDA's stance vis a vis industry compliance\, past problems\, and the growing "cloud" environment. END:VEVENT BEGIN:VEVENT DTSTART;VALUE=DATE:20120307 DTEND;VALUE=DATE:20120308 SUMMARY:Identifying\, Eliminating and Preventing LOCATION:Wilmington\, Delaware\, USA DESCRIPTION:Overview : This webinar takes a close look at the consequences of unlawful sexual harassment in the workplace and trains you in how to ide ntify\, eliminate and prevent it as part of your best practices strategies. Every state prohibits unlawful sexual harassment in the workplace and alm ost every employer has certain specific obligations if sexually harassing c onduct is even suspected\, This webinar takes a look at unlawful sexual har assment and the toll it can take on your workforce and your company's botto m line. You'll learn about the legal definitions of sexual harassment\, th e significant consequences of sexual harassment\, and some of the kinds of conduct that could be unlawful harassment. You'll also learn about your obl igations to do prompt and thorough investigations into harassment allegatio ns and to take effective remedial action. \n \nWhy you should attend: Sexu al harassment demeans your company and your employees and it undermines pro ductivity. It also creates significant legal risks. \n \nAreas Covered In t he Session: \n \n The impact of unlawful sexual harassment in the workpl ace \n Federal definition of unlawful sexual harassment \n State sexu al harassment law issues \n Types and elements of sexual harassment clai ms \n Types of behavior that could be unlawful sexual harassment \n O bligations to do prompt and effective investigations and take appropriate r emedial action \n Corporate and personal liability for unlawful sexual h arassment \n Best practices for identifying\, eliminating and preventing unlawful sexual harassment \n \nWho will benefit: \n \n Managers\, supe rvisors and individual contributors at management levels \n Human Resour ces professionals (business partners\, generalists and functional specialis ts) \n Business Owners \n Administrators and office managers \n Co ntract Managers \n Compliance Professionals \n END:VEVENT BEGIN:VEVENT DTSTART;VALUE=DATE:20120308 DTEND;VALUE=DATE:20120309 SUMMARY:Advanced User Testing with Rolf Molich LOCATION:Bristol\, United Kingdom DESCRIPTION:Rolf Molich\, co-creator of the heuristic evaluation method (wi th Jakob Nielson) and the hugely influential CUE studies\, will be coming t o Bristol in March to share his wisdom in two exclusive workshops. In this first workshop\, he covers advanced user testing. \n \nOrganised by the B ristol Usability Group\, this course gives rare insights into the practical doings of usability professionals\, normally shrouded behind walls of conf identiality. This course is based on the practical accumulated experience - both good and bad - of the almost 100 professional usability teams who par ticipated in the CUE projects\, conducting controlled usability tests in re alistic\, industrial settings. \n \nIf you're a usability professional who has conducted a number of tests\, here is an opportunity to assess and impr ove your skills in the key areas of task creation\, usability moderation\, creating great recommendations\, and communicating results. It’s the best t une-up you’ll ever get. \n END:VEVENT BEGIN:VEVENT DTSTART;VALUE=DATE:20120309 DTEND;VALUE=DATE:20120310 SUMMARY:Measuring Usability with Rolf Molich LOCATION:Bristol\, United Kingdom DESCRIPTION:Rolf Molich\, co-creator of the heuristic evaluation method (wi th Jakob Nielson) and the hugely influential CUE studies\, will be coming t o Bristol in March to share his wisdom in two exclusive workshops. In this second workshop\, organised by the Bristol Usability Group\, he explores t ools and techniques used to measure usability. \n \nQualitative usability testing is by far the most widely used usability method. However\, usabilit y practitioners are discovering that they need to accommodate managers who are no longer satisfied with qualitative data and insist on measurements be cause "You can’t manage what you don’t measure." \n \nThe current literatur e on usability measurements aimed at usability practitioners is very limite d. This course offers practical information about best practice in usabilit y measurements with real users. The course gives rare insights into how exp erienced usability professionals do measurements. The course draws upon fin dings from the recent CUE-8 study where 15 teams including some renowned ex perts independently tested the same web site under realistic conditions. END:VEVENT BEGIN:VEVENT DTSTART;VALUE=DATE:20120313 DTEND;VALUE=DATE:20120314 SUMMARY:Auditing Computer Systems for FDA LOCATION:Virtual DESCRIPTION:Auditing of computer systems is important to verify compliance of the systems with regulations and internal standards. When done right\, a udits can help to improve quality of computer system operation and uptime. In addition audits are also an excellent tool to prepare your organization and staff for external audits\, e.g.\, FDA inspection. However\, without a clear strategy audits can become quite complex and ineffective. \n \nRefer ence material for easy implementation: \nSOPs: Validation of Commercial Off -the-Shelf Computer Systems \nChecklist: Using computers in FDA regulated e nvironments \nValidation templates and examples \nAreas Covered in the Sess ion: \nRegulatory requirements: FDA\, EU\, PIC/S \nAudit recommendations f rom the FDA Quality System guidance for cGMPs \nEffective development and u se of audit checklists \nDeveloping an SOP for audits of computer systems. \nAssigning responsibilities \nConducting the audit: review procedures\, wa lk through the computer system area \nMost critical questions to ask \nAudi ting for data integrity \nAuditing in preparation for FDA's ongoing Part 11 initiative \nDocumenting detailed audit findings \nThe audit summary repor t \nEffective follow up \nPresenting evidence of the audit to the FDA \nCas e study: going through a life audit \nWho Will Benefit: \nQA managers and p ersonnel \nQC and Lab managers \nIT managers and system administrators \nVa lidation specialists \nRegulatory affairs \nTraining departments \nDocument ation department \nConsultants \n \nPrice List: \nLive : $245.00 \nCorporat e live : $995.00 \nRecorded : $295.00 \n \nwebinars@globalcompliancepanel.c om \nhttp://www.globalcompliancepanel.com \n \nPhone: 800-447-9407 \nFax: 302-288-6884 \n END:VEVENT BEGIN:VEVENT DTSTART;VALUE=DATE:20120313 DTEND;VALUE=DATE:20120314 SUMMARY:Changes in the EU Medical Device Directives LOCATION:Virtual DESCRIPTION:Overview: This webinar is focused on understanding the requirem ents of the Medical Device Directives\, their linkage to the EU Clinical Tr ial Directive and the requirements of CE Marking and ISO Certification on c ommercializing products. \n \nKey Topics to be Discussed: \nThe current re gulatory situation in relation to Medical Devices in the EU. \nThe purpose of the Medical Device Directives. \nMeeting the New Requirements for Confor mity Assessment by Product Type. \nUnderstanding the impact the Directive w ill have on developing and marketing new Medical Device products. \n \nWho will benefit: \nClinical research and medical operations \nProject Managers \nProduct Development personnel \nManufacturing personnel \nResearchers ma naging Medical Device R&D and Development \nQuality Assurance such as GMP\, GCP Auditors \nRegulatory affairs \nClinical trial supply personnel \nCRO personnel \n \nPrice List: \nLive : $245.00 \nCorporate live : $995.00 \nRe corded : $295.00 \n \nwebinars@globalcompliancepanel.com \nhttp://www.glob alcompliancepanel.com \n \nPhone: 800-447-9407 \nFax: 302-288-6884 \n \n END:VEVENT BEGIN:VEVENT DTSTART;VALUE=DATE:20120316 DTEND;VALUE=DATE:20120317 SUMMARY:Cleanroom Cleaning in a FDA Regulated Environment LOCATION:Palo Alto\, California\, USA DESCRIPTION:Why Should You Attend: \n \nDesigning an effective cleaning and disinfection program is a critical part of your facility operations and co ntamination control program to meet FDA\, EMA\, and MHRA regulations. This process involves selecting the most effective products against your isolate s\, rotating these products\, and having a safe and effective method to app ly these products. oday end users typically struggle with how often to rota te products and determining exactly which products to rotate. \n \nThis 90- minute presentation will cover all the necessary components that will allow end users to be in compliance with FDA and EMEA. \n \nAreas Covered in the Seminar: \n \n - Effective ways to rotate disinfectants. \n - The need to control bioburden involves a sound cleaning and disinfection program. \n - The most current industry methods for applying disinfectants. \n - Effectiv e methods for controlling residues. \n - All the necessary components will be discussed that will allow end users to be in compliance with FDA and EME A. END:VEVENT BEGIN:VEVENT DTSTART;VALUE=DATE:20120320 DTEND;VALUE=DATE:20120321 SUMMARY:Excel Spreadsheet Validation to Eliminate 483s LOCATION:Virtual DESCRIPTION:What makes this session unique is the combination of step-by-st ep instructions and the hands on workings of each participant. Bring your l aptop and use Excel for your own needs. This session will make you a better Excel user\, saving you time and costs. \nAreas Covered in the Session: \n Develop spreadsheet applications that are GxP compliant. \nAvoid 483s and w arning letters. \nWhat does and does not need to be validated. \nLearn ho w to use Excel’s built in 21 CFR Part 11 features. \nApply features require d for GxP environments without programming macros. \nValidate your applicat ion with minimal documentation. \nFollow along as we configure Excel for au dit trails\, security features\, data verification\, and multiple concurren t users. \nWho Will Benefit: \nAll Excel users \nIT \nQA \nQC \nLaboratory staff \nManagers \nExecutives \n \nPrice List: \nLive : $245.00 \nCorporate live : $995.00 \nRecorded : $295.00 \n \nwebinars@globalcompliancepanel.co m \nhttp://www.globalcompliancepanel.com \n \nPhone: 800-447-9407 \nFax: 3 02-288-6884 \n END:VEVENT BEGIN:VEVENT DTSTART;VALUE=DATE:20120320 DTEND;VALUE=DATE:20120321 SUMMARY:Good Clinical Practice in Drugs and Medical Device LOCATION:Palo Alto\, California\, USA DESCRIPTION:Why Should You Attend: \n \nTo be able to achieve sustainabilit y and to remain sustainable and competitive in global medical product marke ts\, it is necessary to streamline regulatory compliance processes\, in par ticular\, the Good Clinical Practice (GCP) for clinical trials and studies and beyond. To establish and maintain GCP\, it is critical to accurately de fine\, document and implement “current\, accurate\, and complete” (CAC) req uirements pursuant to the relevant and applicable laws and regulations\, GC P requirements\, and compliance in a systematic\, integrative (SI) manner. \n \nThis webinar is intended to help you establish an effective Good Clini cal Practice (GCP) by providing a current\, accurate and complete (CAC) rev iew and understanding of the relevant and applicable regulations for clinic al trials or studies\, the requirements and compliance in a systematic\, in tegrative (SI) manner\, all of which are regulated by the United States Foo d and Drug Administration (FDA). At the end of this webinar\, you will leav e empowered with the knowledge of applicable FDA regulations and requiremen ts. END:VEVENT BEGIN:VEVENT DTSTART;VALUE=DATE:20120320 DTEND;VALUE=DATE:20120321 SUMMARY:The 510(k) Submission: Requirements and Options LOCATION:Virtual DESCRIPTION:Areas Covered in the Session: \nWhen to submit a 510(k) for a n ew or modified product \nTypes of 510(k) submissions and when to use each \ nWhat is the submission process \nWhat is contained in a 510(k) submission package \nHow to know whether clinical data is required \nHow is the submis sion package assembled \nUser fees and 510(k) submissions \nHow to interact with the FDA and the reviewer \nWho Will Benefit: This webinar will provid e valuable assistance to all medical device companies that prepare 510(k) s ubmissions. The employees who will benefit include: \nExecutive Management \nRegulatory Management \nProfessionals involved with premarket notificatio n to the FDA \nR&D personnel involved in approving the design of medical de vices \nSales personnel involved in approving the marketing of medical devi ces \n \n \nPrice List: \nLive : $245.00 \nCorporate live : $995.00 \nRecor ded : $295.00 \n \nwebinars@globalcompliancepanel.com \nhttp://www.globalc ompliancepanel.com \n \nPhone: 800-447-9407 \nFax: 302-288-6884 \n END:VEVENT BEGIN:VEVENT DTSTART;VALUE=DATE:20120321 DTEND;VALUE=DATE:20120322 SUMMARY:Master Verification & Validation Planning LOCATION:Virtual DESCRIPTION:Why you should attend: Verification and validation requirements have always been part of the US FDA's GMPs. However\, with increasing tech nology\, both industry and regulatory agencies expectations have increased. Recent high-profile field problems indicate that V&V activities are not pl anned or carried out as completely as expected\, and may not be fully utili zing the power of current risk management tools\, as identified in ISO 1497 1. The FDA / ICH Q-series provide valuable insights for all regulated indus tries\, not just Pharma. The billions of dollars spent by industry annually for V&V are not providing the product safety or efficacy seemingly promise d. For most companies\, the fixes are not rocket-science\, but proper up-f ront V&V planning and execution. \n \nAreas Covered in the Session: \nVerif ication or Validation - Recent regulatory expectations \nThe Master Valida tion Plan / structure \nProduct Validation – how it differs from process / equipment V&V \nProcess / Equipment / Facility Validation -- FDA's new guid ance \nWhen and How to use DQ\, IQ\, OQ\, PQ\, or their equivalents \nHow t o use Product Risk Management Tools (per ISO 14971 and ICH Q9) \nThe 11 key documents for software validation \nIncorporating 21 CFR Part 11 requireme nts \nSuggested “test case” formats \nWho Will Benefit: \nSenior management in Drugs\, Devices\, Biologics\, Dietary Supplements \nQA \nRA \nR&D \nEn gineering \nProduction \nOperations \nConsultants \n \nPrice List: \nLive : $245.00 \nCorporate live : $995.00 \nRecorded : $295.00 \n \nwebinars@glob alcompliancepanel.com \nhttp://www.globalcompliancepanel.com \n \nPhone: 8 00-447-9407 \nFax: 302-288-6884 \n END:VEVENT BEGIN:VEVENT DTSTART;VALUE=DATE:20120322 DTEND;VALUE=DATE:20120323 SUMMARY:DHF\, DMR\, DHR\, and the Technical File LOCATION:Virtual DESCRIPTION:This webinar will examine the existing and proposed requirement s for the FDA's DHF -- including its derivative documents\, the DMR and DHR . \n \nWhy you should attend: One of our most popular webinars\, updated w ith the latest FDA and EU requirements. As U.S. companies go global\, they must meet different product design documentation. The cGMPs mandate Design Control and the Design History File (DHF). In order to sell globally\, the EU's CE-marking documentation is a requirement -- the Technical File or Des ign Dossier. Currently they serve different purposes\, support different go als\, but the TF/DD is moving in the direction of the DHF. And the DHF is a dapting to some of the features of the TF/DD. And how / where do the DMR an d DHR fit? Being aware of the similarities and differences can further conc urrent development and/or updates to both. \n \nAreas Covered in the Sessio n: \nThe U.S. FDA's DHF \nThe EU's MDD and the Technical File / Design Doss ier \nDesign Control vs. a Product 'Snapshot in Time' \nDHF "Typical" Conte nts \nThe DMR and DHR / Lot / Batch Record \nTF / DD Expected Contents \nPa rallel Approaches to Documentation -- Teams \nFuture Directions \nFDA and N B Audit Focus \nWho Will Benefit: \nSenior management in Drugs\, Devices\, Biologics\, Dietary Supplements \nQA \nRA \nR&D \nEngineering \nProduction \nOperations \nMarketing \n \n \nPrice List: \nLive : $245.00 \nCorporate live : $995.00 \nRecorded : $295.00 \n \nwebinars@globalcompliancepanel.com \nhttp://www.globalcompliancepanel.com \n \nPhone: 800-447-9407 \nFax: 30 2-288-6884 \n END:VEVENT BEGIN:VEVENT DTSTART;VALUE=DATE:20120322 DTEND;VALUE=DATE:20120323 SUMMARY:Post Market Surveillance for Medical Devices LOCATION:Virtual DESCRIPTION:Why you should attend: Post market surveillance can be complica ted\, but by breaking it down into its parts\, it can be accessible. With t he understanding of the parts\, you can develop and implement a comprehensi ve system that will help you stay in compliance. By attending this webinar\ , you will find out what you need to do and be well on the way to effective performance. \n \nAreas Covered In the Session: \nThe Structure of Post Ma rket Surveillance \nUS System \nComplaints (QSR) \nMedical Device Reports \ nCorrections and Removals \nInternational Systems \nComplaints (ISO 13485) \nEU Vigilance \nEU FSCA and FSN \nCanada Adverse Event Reporting \nPost Pr oduction Information Collection \nRisk Management (ISO 14971) \nClinical Ev aluation (MDD Annex X) \nWho will benefit: \nQuality Managers \nRegulatory Affairs Managers \nRisk Managers \nDesign Control Managers \n \n \nPrice Li st: \nLive : $245.00 \nCorporate live : $995.00 \nRecorded : $295.00 \n \nw ebinars@globalcompliancepanel.com \nhttp://www.globalcompliancepanel.com \ n \nPhone: 800-447-9407 \nFax: 302-288-6884 \n END:VEVENT BEGIN:VEVENT DTSTART;VALUE=DATE:20120327 DTEND;VALUE=DATE:20120328 SUMMARY:Environmental Monitoring and Contamination Control LOCATION:Palo Alto\, California\, USA DESCRIPTION:Why Should You Attend: \n \nThis 90-minute presentation will re view the basics of personnel practices and discuss cleaning and disinfectio n. The most common source of contamination in the cleanroom are people and as such it is important to cover common mistakes in behavior and gowning. T he speaker will address facility design and conditions as well since these are also a contributor to contamination. As an attendee\, you will get a co mplete overview the basics of how to control your cleanroom environment how to get the best possible yield of products. \n \nAreas Covered in the Semi nar: \n \n - Review the most common mistakes people make in cleanrooms that lead to contamination. \n - Learn how to develop a successful contaminatio n control program. \n - Learn ways to improve facility design and maintenan ce. END:VEVENT BEGIN:VEVENT DTSTART;VALUE=DATE:20120406 DTEND;VALUE=DATE:20120407 SUMMARY:Understanding Disinfectant Qualification Studies LOCATION:Palo Alto\, California\, USA DESCRIPTION:Why Should You Attend: \n \nHow do you design an effective disi nfectant validation program that meets FDA \, MHRA\, EMA scrutiny? \n \nThi s webinar provides guidance on industry trends\, regulatory feedback\, and designs for an effective validation program. Current 483's\, Warning Letter s\, and Field Experiences will be conveyed that allow end users to determin e the best methods to validate their products against their isolates. \n \n Areas Covered in the Seminar: \n \n - Learn disinfectant testing methodolog ies. \n - Review “real world” examples of disinfectant efficacy tests. \n - Increase awareness of pitfalls encountered during testing. \n - Troublesho oting problems related to disinfectant efficacy testing. \n - Examples of d isinfectant validation successes will be discussed. END:VEVENT BEGIN:VEVENT DTSTART;VALUE=DATE:20120423 DTEND;VALUE=DATE:20120427 SUMMARY:UX Intensive LOCATION:Amsterdam\, Netherlands DESCRIPTION:Day One - Strategy \n \nGreat design reflects business strategy and vice versa. Principles of strategy may not change\, but the practice i s constantly evolving. Whether you're working on grand strategy for your pr oduct or want a better understanding of the forces shaping your work\, this workshop dives into the design & strategy dynamic with new thinking\, exam ples from our experience and hands-on exercises. \n \nDay Two - Research \n \nYou need to make design research count. Valuable research collects infor mation and turns that into knowledge and wisdom about what to do next\, but it's often an activity that fails to get the necessary attention and inves tment. Through examples\, a bit of theory and hands-on exercises we'll show you how to get the most for your money\, manage your stakeholders and give your designs the concrete direction needed to deliver great experiences. \ n \nDay Three - Interaction Design \n \nIt takes more than customer insight s and a solid product strategy touccessfully deliver on your customer's exp ectations. The challenge of transforming research insight and business goal s into meaningful and tangible outcomes remains as the primary goal the Int eraction Designer. In this session\, you'll learn to quickly move from abst ract insight\, to sketching\, prototyping and beyond. \n \nDay Four - Digit al Service Design \n \nSuccessful product and service experiences are those that have been orchestrated in a way that best considers the changing need s of people\, along with the efforts of the organizations that serve them. This day brings together the essentials of modern multi-channel information architecture with the emerging practices of services design. You'll take a way tools of modeling and analysis that shape smart and systemic solutions. END:VEVENT BEGIN:VEVENT DTSTART;VALUE=DATE:20120504 DTEND;VALUE=DATE:20120505 SUMMARY:Service Design 2012 LOCATION:Melbourne\, Australia END:VEVENT BEGIN:VEVENT DTSTART;VALUE=DATE:20120531 DTEND;VALUE=DATE:20120603 SUMMARY:Big Design Conference 2012 LOCATION:Addison\, Texas\, USA DESCRIPTION:Back for a fourth year\, the Big Design 2012 Conference will ha ve talks\, panels\, interactive booths\, art\, mixers\, parties\, and more. Learn from experts like Jared Spool\, Stephen Anderson\, Sharron Rush\, J eremy Johnson\, Brian Sullivan\, and 50 other speakers. END:VEVENT BEGIN:VEVENT DTSTART;VALUE=DATE:20120821 DTEND;VALUE=DATE:20120825 SUMMARY:UX Week 2012 LOCATION:San Francisco\, California\, USA DESCRIPTION:Adaptive Path's UX Week is the premier user experience conferen ce. With a mix of inspiring talks from recognized thought leaders and hands -on workshops delivering takeaway skills\, this event delivers for user exp erience professionals at all levels — directors\, managers\, and practition ers. Join us as we celebrate 10 years of UX Week. It just keeps getting bet ter and better! END:VEVENT BEGIN:VEVENT DTSTART;VALUE=DATE:20120828 DTEND;VALUE=DATE:20120901 SUMMARY:UX Australia 2012 LOCATION:Brisbane\, Australia END:VEVENT END:VCALENDAR