Wilmington USA 2012-02-10 Overview : But here's the thing - Even if you learn all the presentation 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 presentation - 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! Whether you are flying solo or leading a team of presenters, Terry will show you how to: Connect with your authentic self, and create a strong presence that your audience or reader can’t resist. Recognize and transform limiting beliefs that operate "under the surface" and contribute to fear Manage your fear and transform the energy into positive power and the ability to create an enjoyable experience for you and your audience! Access the "Power of Intention" as a foundation for your actions Clarify your message, focusing on the "so what" for your audience Develop simple support materials that enhance rather than detract from your presentation Areas Covered In the Session: Connect with your authentic self and create s strong message that your audience or reader can't resist Recognize and transform limiting beliefs that operate "under the surface and contribute to fear Manage your fear and transform the energy into positive power and the ability to create an enjoyable experience for you and your audience Access the "Power of Intention" as a foundation for your actions Clarify your message, focusing on the "so what" for your audience Develop simple support materials that enhance rather than detract from your presentation Who will benefit: Entrepreneurs Sales Managers Sales Executives Business Development Managers and Staff 1758 DE Have you noticed that there's a lot of great information out there about how to speak in public - or how to write an effective report or sales proposal? 2012-02-09 false http://www.trainhr.com/control/w_product/~product_id=700092 http://events.boxesandarrows.com/events/1758 http://events.boxesandarrows.com/event/logo/1758/TrainHR_logo.jpg compliance, hr audits, hr compliance, hr training, hr webinar, internal auditors, law, regulatory, skills, training Palo Alto USA 2012-02-11 Why Should You Attend: Perhaps of all of the interactions that occur with regulatory agencies, the unannounced OSHA inspection is the most stressful, and least understood by business owners. The key to managing a surprise OSHA Inspection or a letter of complaint directed at your company is to understand what the process is and what the OSHA inspectors are looking for. This presentation will explain what the process is for an OSHA inspection, and how to respond to a letter of complaint. Also, this presentation will explain what inspectors are looking for, how employees and unions figure into the inspection equation , and what you must do to expedite the inspection and help resolve issues before they become major problems. This session will help business owners and safety personnel have a better understanding and feel more in control of the situation when OSHA inspectors arrive at your site, especially if they arrive unannounced. 1737 CA This OSHA Inspection and Accident Investigation training will provide practical tips for safety professionals and managers on what the OSHA inspectors. 2012-02-10 false http://www.complianceonline.com/ecommerce/control/trainingFocus/~product_id=702176?channel=boxes&arrow http://events.boxesandarrows.com/events/1737 http://events.boxesandarrows.com/event/logo/1737/ComplianceOnline_2011.jpg accident investigations, osha inspection guidelines, osha inspections Palo Alto United States 2012-02-15 The US FDA has issued a draft guidance document outlining a suggested approach to complying with current good manufacturing practice (CGMP) requirements for drugs intended soley in Phase 1 studies.With this guidance and an accompanying regulation, US FDA formally recognizes specific standards for the manufacture of small amounts of drug products for phase 1 studies and formulating an approach to cGMP compliance that is appropriate for the particular stage of drug development. This presentation will give an insiders insight into the the new guidance and regulation and discuss the rationale for such. 1721 United States This US FDA draft guidance documentation webinar/ training will give an insider’s insight into the new guidance and regulation and discuss the rationale for such. 2012-02-14 false http://www.complianceonline.com/ecommerce/control/trainingFocus/~product_id=700155?channel=boxes&arrow http://events.boxesandarrows.com/events/1721 http://events.boxesandarrows.com/event/logo/1721/ComplianceOnline_2011.jpg phase 1 drugs compliance, phase 1 ind regulations, phase 1 ind studies, phase 1 investigational drugs Waltham USA 2012-02-16 How do you design interactions that make a user able to navigate, understand, and appreciate their data? Data visualization has emerged as a primary technique for understanding large datasets. The past decade's surge of available data inspires much discussion about visualization techniques. The discussion tends to focus on a visual language for static presentation, but rarely addresses the range of interactions that are possible in a digital environment. Mark Schifferli of Fathom Information Design will show examples of how interaction techniques can further push an audience’s understanding of a complex data set. 1757 MA Mark Schifferli will talk about interacting with data visualizations of complex sets of data. Date: Wednesday, February 15 2012 Time: 7PM Where: Constant Contact, Reservoir Place, Waltham, MA 2012-02-15 false http://www.eventbrite.com/event/2607836108 http://events.boxesandarrows.com/events/1757 http://events.boxesandarrows.com/event/logo/1757/BostonCHI_logo.png data visualizations, fathom information design, interacting with data Palo Alto USA 2012-02-16 Why Should You Attend: A critical component in successful Clinical Research Trials is ensuring that you choose the right CRO/AOR based on the phase of the trial, the therapeutic area and the countries that the trials will be conducted. It is then important that the scope of the work 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 Project Managers on both sides easier. This presentation will show how you can manage the CRO/ARO in this environment of multi-center, multi-country trials. We will discuss how you can ensure that you comply with regulations in the various countries from shipping drug to ensuring that the inclusion criteria are well understood in all countries and that the appropriate patients are enrolled. Diagnostic criteria are not always interpreted in the same manner. This is particularly true in some therapeutic areas such as CNS. We will also review the current trend towards enrolling pediatric patients as well as elderly and more vulnerable populations, and the challenges that go with it, in the various environments that studies are conducted. 1777 CA This training on hiring and managing CROs or AROs will show how you can ensure that you choose the right CRO/ARO based on the phase of the trial. 2012-02-15 false http://www.complianceonline.com/ecommerce/control/trainingFocus/~product_id=702232?channel=boxes&arrow http://events.boxesandarrows.com/events/1777 http://events.boxesandarrows.com/event/logo/1777/ComplianceOnline_2011.jpg cro hiring, cro recruitment, hiring aros, patient recruitment, study close out, study report phase Wilmington USA 2012-02-16 Overview : What do you do when they contact you? Panic, Procrastination, Belligerence and Ignorance are big mistakes! The IRS takes a variety of steps to combat employment tax non-compliance, with the upshot being significant criminal penalties and convictions resulting in incarceration, heavy fines, or usually both. Whether there is a violation or not, all of those steps begin with written and oral communication to the entities involved. Proper courtesy goes a long way to make your experience easier but more than that is needed to ensure successful communication. Why you should attend: Attend this webinar to understand how to communicate more effectively with the IRS and other regulatory agencies. Use of the information and strategies presented can significantly reduce anxiety, provide Added clarity in response to official communications and in some cases help prevent simple issues from escalating to serious situations. Areas Covered In the Session: In this webinar you will learn: How to determine what is - and is not - an IRS notice Step by step instructions on how to respond to an IRS notice Dos and don'ts of corresponding with the IRS or any government agency Tips on preparing for an audit Best practices for payroll departments to avoid audits How to beat them to it - strategies to conduct your own internal audit Who will benefit: Payroll professionals Human Resources Accounting Personnel Business Owners Lawmakers Attorneys Any individual or entity that must deal with the complexities and technicalities of the payroll process 1760 DE This webinar delves into what to (and not to) do when you receive communications from the IRS and also what to do when doing business with other federal, state and local regulatory agencies 2012-02-15 false http://www.trainhr.com http://events.boxesandarrows.com/events/1760 http://events.boxesandarrows.com/event/logo/1760/TrainHR_logo.jpg attorneys, benefits, best practices, business writing, change management, communications and interpersonal skills, compliance, evaluation methods and metrics, hr audits, hr compliance, hr training, hr webinar, innovative methods, internal auditors, law, lawmakers, planning strategies, policy making, presentations skills, regulatory, technology in hr, training development Wilmington USA 2012-02-17 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 businesses have different obligations to each of them. To comply with those obligations, you should be familiar with the various independent contractor tests 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. Why you should attend: Every business has to classify their workers as employees or independent contractors. When it comes to independent contractor 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 used 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. Areas Covered In the Session: The current compliance and enforcement environment when it comes to worker misclassifications Benefits and pitfalls of using independent contractors Understanding the various federal and state tests for proper classification of independent contractors The scope of penalties for improper classification Information about recent classification lawsuits and investigations Best practices for entering into and maintaining independent contractor relationships Who will benefit: Managers and supervisors Human Resources professionals (business partners, generalists and functional specialists) Payroll professionals Business Owners Administrators and office managers Contract Managers Compliance Professionals 1761 DE This webinar is focused on classification of independent contractors in an economic environment where misclassification is currently being viewed as a revenue source by government agencies 2012-02-16 false http://www.trainhr.com http://events.boxesandarrows.com/events/1761 http://events.boxesandarrows.com/event/logo/1761/TrainHR_logo.jpg attorneys, benefits, best practices, business writing, change management, communications and interpersonal skills, compliance, evaluation methods and metrics, hr audits, hr compliance, hr training, hr webinar, innovative methods, internal auditors, law, lawmakers, planning strategies, policy making, presentations skills, regulatory, technology in hr, training development Palo Alto United States 2012-02-17 Why You Should Attend: Negative customer feedback about a medical device's performance or safety is a strong indicator of whether a firm's manufacturing process is in control. This feedback is therefore subject 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 observations on FDA-483s. This session will include the requirements for defining, documenting, and implementing a complaint-handling system, including the requirements for complaint review, investigation, and corrective action, as well as the ISO-specific implications. 1712 United States This training will show how you can handle customer complaints in compliance with FDA and ISO Regulations. 2012-02-16 false http://www.complianceonline.com/ecommerce/control/trainingFocus/~product_id=700986?channel=boxes&arrow http://events.boxesandarrows.com/events/1712 http://events.boxesandarrows.com/event/logo/1712/ComplianceOnline_2011.jpg customer complaint fda regulations, customer complaints, customer feedback management, handling customer complaints Palo Alto United States 2012-02-18 Why Should You Attend: The new HIPAA compliance audit program has been announced and is now under way, bringing HIPAA compliance audits to up to 150 HIPAA Covered Entities by the end of 2012. If your organization is not ready, the HIPAA rules have new, significantly higher fines, including mandatory minimum fines of $10,000 for willful neglect of compliance. In this session we will discuss the HIPAA audit and enforcement processes and how they apply to covered entities and business associates. We will explain the enforcement regulations and their recent changes. We will discuss what information and documentation needs to be prepared in advance so that you can be ready for an audit without notice. Sample information 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 audit 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 done to prevent incidents that lead to enforcement. 1729 United States This 3-hr virtual seminar on HIPAA Privacy and Security Audits and Enforcement will cover HIPAA Privacy, Security, and Breach Notification regulations. 2012-02-17 false http://www.complianceonline.com/ecommerce/control/trainingFocus/~product_id=702193?channel=boxes&arrow http://events.boxesandarrows.com/events/1729 http://events.boxesandarrows.com/event/logo/1729/ComplianceOnline_2011.jpg hipaa enforcement, hipaa privacy audit, hipaa security audits Palo Alto USA 2012-02-18 Why Should You Attend: Asbestos is one of the most highly regulated substances, and for good reasons as it’s a potent carcinogen with no known safe exposure. Of all of the toxic and hazardous substances it could have regulated, OSHA chose to regulate Asbestos first. Mold, 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 apply. In this 3-hour session we will cover the required elements of the 2-hour awareness training OSHA requires for Asbestos, as well as the OSHA Mold guidelines and many of their applicable regulations. Learning Objectives: At the end of the training, learners should be able to: - Describe what Asbestos is and its various forms. - Explain the adverse health effects of asbestos. - List the different steps to avoid exposures to Asbestos. - Delineate the general OSHA requirements for Asbestos. - List the various OSHA regulations that apply to Mold. 1738 CA This 3-hr virtual seminar - OSHA Asbestos and Mold Awareness - will cover OSHA's regulations on Asbestos and specific guidelines and general regulations on Mold. 2012-02-17 false http://www.complianceonline.com/ecommerce/control/trainingFocus/~product_id=702197?channel=boxes&arrow http://events.boxesandarrows.com/events/1738 http://events.boxesandarrows.com/event/logo/1738/ComplianceOnline_2011.jpg osha asbestos and mold regulations, osha guidelines for mold, osha regulations on asbestos Palo Alto United States 2012-02-22 Why Should You Attend: Global companies must meet different 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 requirement -- the Technical File or Design Dossier. Currently they serve different purposes, support different goals, but the TF/DD is moving in the direction 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 concurrent development / documentation, and/or updates to both. What are DMRs and DHRs relationship to DHFs, TF/DDs? 1713 United States This webinar will examine in detail the U.S. FDA and EU MDD requirements for DHFs, DMRs, DHRs, and TF/DDs -- their commonalities and their differences. 2012-02-21 false http://www.complianceonline.com/ecommerce/control/trainingFocus/~product_id=701898?channel=boxes&arrow http://events.boxesandarrows.com/events/1713 http://events.boxesandarrows.com/event/logo/1713/ComplianceOnline_2011.jpg design history files, device history records, device master records Palo Alto USA 2012-02-23 Why Should You Attend: The 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 doctors that there are genetic variances that effect safety profile for drugs such as codeine and clopidogrel. These FDA mandates have driven the adoption of pharmacogenomic testing into clinical practice to date. Pharmacogenomic laboratory tests are available for these drugs.Adverse events caused by these drugs may lead to medical malpractices should there be a failure to account for these variances. Personalized medicine involves providing the right drug for the right patient at the right time. Drug dosing regimens for medications in routine clinical practice are established for the majority of individuals (wildtype). Unfortunately, individuals with genetic variances in genes that encode drug metabolizing or transport enzymes who are given standard dosages can result in poor drug efficacy or significant toxicity. Clinical pharmacogenetic testing is a means for personalizing medicine. This 90-minute presentation will cover the basic principles of pharmacogenomics and pharmacogenetics and will discuss in detail the steps behind implementing a clinical pharmacotenomic testing service. 1778 CA This 90-minute webinar will cover the basic principles of pharmacogenomics and pharmacogenetics and will discuss in detail the steps behind implementing a clinical pharmacotenomic testing service. 2012-02-22 false http://www.complianceonline.com/ecommerce/control/trainingFocus/~product_id=702239?channel=boxes&arrow http://events.boxesandarrows.com/events/1778 http://events.boxesandarrows.com/event/logo/1778/ComplianceOnline_2011.jpg clinical pharmacogenetic testing, fda drug relabeling, pharmacotenomic testing, therapeutic efficacy Palo Alto United States 2012-02-24 Why Should You Attend: 50% of the drugs presently in discovery are biopharmaceuticals - these numbers lead to an "outsource or perish" philosophy for GMP/GLP development, validation and sample analysis. Unlike synthetic drugs requiring only straightforward analytical testing biopharmaceuticals 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. Participants in this seminar will attain a valuable checklist of critical information 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. 1694 United States This Bioassays webinar will systematically outline the steps needed to successfully transfer validated biological assays between GMP/GLP labs. 2012-02-23 false http://www.complianceonline.com/ecommerce/control/trainingFocus/~product_id=700374?channel=boxes&arrow http://events.boxesandarrows.com/events/1694 http://events.boxesandarrows.com/event/logo/1694/ComplianceOnline_2011.jpg assay transfer, gmpglp labs, nonvalidated assays, transfer of bioassays, validated assays Palo Alto United States 2012-02-24 Why Should You Attend: Having a plan for gathering and compiling appropriate sterility assurance documentation to be included in a global marketing application is essential for injectable drug products. In this session we will provide an overview of current regulatory guidance and compendial requirements associated with sterilization validation and control of microbial quality. We will review what information is needed, what level of detail is included, and how to present the documentation in CTD format. Attendees will also learn what data and information need to be included in your submission for different approaches (terminal sterilization vs. aseptic processes) to manufacturing a sterile drug product. We will review information needed in support of the sterilization and depyrogenation of container closure components, filter validation, heat penetration and distribution studies, and container closure integrity testing. 1722 United States In this sterility assurance documentation webinar, you will learn specifically what information is required in sterility assurance documentation. 2012-02-23 false http://www.complianceonline.com/ecommerce/control/trainingFocus/~product_id=701926?channel=boxes&arrow http://events.boxesandarrows.com/events/1722 http://events.boxesandarrows.com/event/logo/1722/ComplianceOnline_2011.jpg sterility assurance documentation, sterilization process validation, submission documentation Palo Alto United States 2012-02-24 Why Should You Attend: This 6 hour virtual seminar will help you gain a comprehensive understanding of the Regulatory Structure, Clinical Trial Requirements and the Conduct of Running Clinical Research in Japan. It will prepare you for the regulatory approval processes, Agency meetings, the complexities of running studies in Japan, the importance of partner selection and add the cultural knowledge needed for success. The recent changes made by PMDA to be more sponsor-friendly will be reviewed. Real world experiences on actual interactions with the Agency since these changes, will also be discussed. 1701 United States This Japan Regulatory and Clinical Trial Requirements training will cover Japan Regulatory Agency Structure and Responsibilities, its review process for decision-making and approval. 2012-02-23 false http://www.complianceonline.com/ecommerce/control/trainingFocus/~product_id=702170?channel=boxes&arrow http://events.boxesandarrows.com/events/1701 http://events.boxesandarrows.com/event/logo/1701/ComplianceOnline_2011.jpg clinical research in japan, japan clinical trial requirements, japan regulatory requirements Palo Alto United States 2012-02-24 Why You Should Attend: Prior to introduction of a new device, or even a modified design for an existing device, a systematic process must be followed. This process must ensure that all requirements are met. A firm's design control process must meet all regulatory requirements, but at the same time not be as unwieldy as the present a barrier to timely market introduction. This webinar will cover the basics of design controls, and provide recommendations for implementation of a compliant design control system. Also discussed will be design control requirements for devices already in distribution. Documentation requirements for each design stage will be included as well. 1714 United States This webinar will cover the basics of design controls for medical devices, and provide recommendations for implementation of a compliant design control system. 2012-02-23 false http://www.complianceonline.com/ecommerce/control/trainingFocus/~product_id=701285?channel=boxes&arrow http://events.boxesandarrows.com/events/1714 http://events.boxesandarrows.com/event/logo/1714/ComplianceOnline_2011.jpg design control, design control requirements, documentation requirements, medical device design control Palo Alto USA 2012-02-25 Why Should You Attend: Waived testing is an exciting way to leap into the world of laboratory testing. With over a hundred tests to choose 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 under CMS and how to best meet them. We also will explore the many tests available and how they can benefit your patients. Waived labs make up the majority of laboratory testing taking place in this country and more tests are being added to the Waived category all the time. With less regulatory oversight, 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. Areas Covered in the seminar: - Waived testing history and origins. - Waived testing CLIA rules and regulations. - Waived tests available and how they fit into your practice. - How to apply for Waived testing and the State's role. - The future of Waived testing and how it affects you - Waived testing pitfalls to avoid. 1733 CA This CLIA Webinar training will feature an in-depth look at CLIA Waived Testing. It will present the rules and regulations as well as the pros and cons of testing using Waived methods. 2012-02-24 false http://www.complianceonline.com/ecommerce/control/trainingFocus/~product_id=701523?channel=boxes&arrow http://events.boxesandarrows.com/events/1733 http://events.boxesandarrows.com/event/logo/1733/ComplianceOnline_2011.jpg clia compliance training, clia waived testing, clia waived testing regulations, waived testing rules Palo Alto USA 2012-02-29 Why Should You Attend: The U.S. government takes violations of economic sanctions prohibitions very seriously. Just recently, JP Morgan Chase had to pay $88.3 million to settle allegations that it had violated a number of OFAC administered sanctions prohibitions. This type of penalty is not abnormal as for most sanctions violations OFAC can administered penalties 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 publically available many are lost when it comes down to how an OFAC investigation and enforcement action should be handled. Defending against an investigation from the United States Department of the Treasury Office of Foreign Assets Control (OFAC) can be a stressful process. Careful navigation and understanding of this process is required to shield one’s self or company from massive penalties and reputational risk. This webinar is designed to teach participants how to successfully navigate the OFAC enforcement process and reduce any OFAC penalties. 1746 CA This webinar on Defending Against OFAC Investigations is designed to teach participants to successfully navigate the OFAC enforcement process and reduce any OFAC penalties. 2012-02-28 false http://www.complianceonline.com/ecommerce/control/trainingFocus/~product_id=702190?channel=boxes&arrow http://events.boxesandarrows.com/events/1746 http://events.boxesandarrows.com/event/logo/1746/ComplianceOnline_2011.jpg defending against an ofac investigation, ofac enforcement, ofac investigation Palo Alto United States 2012-03-01 Why Should You Attend: Have you ever been confused about what needs to be in your Device Master Record (DMR) and your Device History Record (DHR)? This webinar will help you understand the requirements and assemble a complaint DMR and use it to build your DHR. The 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 the 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 speaker will advise you on when to put device information into the QSR. 1715 United States This 90-minute training will discuss the FDA's QSR requirements for a Device Master Record (DMR) and how you can use it to build your Device History Record (DHR). 2012-02-29 false http://www.complianceonline.com/ecommerce/control/trainingFocus/~product_id=701861?channel=boxes&arrow http://events.boxesandarrows.com/events/1715 http://events.boxesandarrows.com/event/logo/1715/ComplianceOnline_2011.jpg medical device history record implementation, medical device master record implementation 2012-03-02 Why should you attend: Imagine this! Your company uses acceptance sampling in your manufacturing process and your manager asked to make sure 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 have 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 and isn’t available to help. You have also heard about some new methods called c=0 or zero based acceptance. How do you know how much your inspection system costs? Are you inspecting too much, and wasting money? Are you inspecting too little and incurring risk? Do your current managers and supervisors understand how the system works? Will your ISO 9001 registrar ask for justification of these statistical methods? Should you start to use these c=0 plans you have heard about? Who Will Benefit: This seminar is designed for people in manufacturing who are involved in setting product specifications, setting up acceptance plans, performing acceptance activities, and supply chain management. Attendees should have knowledge of manufacturing process that includes acceptance activities such as incoming, in-process, and final acceptance. This typically includes: Quality Engineers Production and Process Engineers Manufacturing Engineers Design Engineers Purchasing Managers Purchasing Agents Supplier Quality Engineers Quality Supervisors Quality Inspectors Quality Managers Price List: Live : $245.00 Corporate live : $995.00 Recorded : $295.00 webinars@globalcompliancepanel.com http://www.globalcompliancepanel.com Phone: 800-447-9407 Fax: 302-288-6884 1774 This course provides the attendees with the tools needed to understand and implement acceptance sampling. 2012-03-01 true http://bit.ly/yOhGQW http://events.boxesandarrows.com/events/1774 http://events.boxesandarrows.com/event/logo/1774/GlobalCompliancePanel_Logo.jpg aoq, asn, ati, c0 plans, dan oleary, online training, sampling, z14 2012-03-02 Learn about the risks and complications involved with the application of sound verification and validation principles. Why Should You Attend: The meanings and regulatory requirements of the terms "verification" and "validation" are often confusing to engineers and even some regulatory professionals. FDA regulations as well as European standards such as ISO 13485:2003 require both verification & validation documentation throughout these regulations and standards.The terms apply to design control, process control and others. Verification and validation also appear in the "essential 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. Areas Covered in the Seminar: Verification & validation types Definitions Design control Process control Application Consequences of poor verification & validation Why verification & validation makes good business sense Who Will Benefit: Employees who will benefit include: Quality & Regulatory Professionals Manufacturing & Design Engineers Marketing Product Managers Corporate & Operations Executives Price List: Live : $245.00 Corporate live : $995.00 Recorded : $295.00 webinars@globalcompliancepanel.com http://www.globalcompliancepanel.com Phone: 800-447-9407 Fax: 302-288-6884 1773 Attend this webinar to understand the differences and benefits of verification and validation. 2012-03-01 true http://bit.ly/wIPeRf http://events.boxesandarrows.com/events/1773 http://events.boxesandarrows.com/event/logo/1773/GlobalCompliancePanel_Logo.jpg application, design control, iso 13485, mdd 93, online training, regulated industries Sydney Australia 2012-03-04 Agile UX 2012 is a single day, single track conference about designing great user experiences within an agile development process. It’s not at all about how to do UX quicker or leaner. It’s not just about how to fit user research and usability testing into Agile, or how to communicate user needs. It’s more than those – it’s about how great experiences are designed and created within the structure of an agile development process. Registration is open now. 1764 Australia Agile UX 2012 is a single day, single track conference about designing great user experiences within an agile development process. 2012-03-03 false http://www.uxaustralia.com.au/agileux-2012/ http://events.boxesandarrows.com/events/1764 agile, user experience San Francisco USA 2012-03-06 About This Event MX is a conference for people who take a leadership role in guiding better experiences into the world. Learn from real-world examples and discover new approaches that can help you lead your organization toward investing in, or improving your customer experience on the web, mobile, and beyond. SPEAKERS Genevieve Bell, Intel Labs (Keynote) April Showers, United Airlines Brandon Schauer, Adaptive Path Chris Risdon, Adaptive Path Dane Howard, eBay Greg Petroff, GE Ian Swinson, Salesforce Kevin Nolan, Strategy Analytics Kip Lee, PhD Candidate @ Case Western Reserve University Laura Kirkwood-Datta, Adaptive Path Lynne Waldera, InMomentum Melissa Matross, The Hotwire Group Miguel Lunaparra, Sony Nancy Dickensen, Dickenson, LLC Paula Wellings, Adaptive Path Thor Muller, Get Satisfaction Vidya Drego, Forrester Research WORKSHOPS Sarah B. Nelson, Tapir & Tine Richard Dalton, Vangaurd TWITTER @mxconf 1751 CA A conference for managers & leaders of user experience teams. 2012-03-04 false http://mxconference.com http://events.boxesandarrows.com/events/1751 cross channel, customer experience, experience design, interaction, ixd, management, strategy, user experience, ux 2012-03-07 Areas Covered in the Session: Which data and systems are subject to the regulations? What the regulations mean, not just what they say. Avoid 483 and Warning Letters. Examine the regulatory requirements for the three primary areas of Part 11 compliance: SOPs, software product features, and validation documentation. Ensure data integrity, security, and protect intellectual property. Understand the current computer system industry standards for security, data transfer, and audit trails. Electronic signatures, digital pens, and biometric signatures. Evaluate the regulatory requirements related to the current computer system standards for security, data transfer, audit trails, electronic signatures, digital pens, and biometric signatures. SOPs required for the IT infrastructure. Product features to look for when purchasing COTS software. Reduce validation resources by using easy to understand fill-in-the-blank validation documents. Who Will Benefit: IT QA QC Laboratory staff Managers GMP, GCP, GLP professionals Price List: Live : $245.00 Corporate live : $995.00 Recorded : $295.00 webinars@globalcompliancepanel.com http://www.globalcompliancepanel.com Phone: 800-447-9407 Fax: 302-288-6884 1770 This webinar details both regulations and provides details for implementing computerized systems. 2012-03-06 true http://bit.ly/xaN4DV http://events.boxesandarrows.com/events/1770 http://events.boxesandarrows.com/event/logo/1770/GlobalCompliancePanel_Logo.jpg 21 cfr part 11, biometric signatures, cots software, new regulatory audits, online training, part 11 compliance, regulatory requirements, validation documents, warning letters 2012-03-07 Why you should attend: The lines of distinction between the classical phases in the drug development are becoming more and more blurred, and the challenges facing the Sponsor, the Principal Investigator, and the sites are becoming increasingly important. These challenges must be known and appreciated Areas Covered In the Session: What is the roll of the Investigators Brochure in the FiM process? What do you expect to learn from the FiM study? What are the factors in choosing the first does of a NCE The challenge of developing an effective / efficient Phase I Program How to recruit Study Participants in this new age of Social Media The importance of accurately assessing and reporting Adverse Events The importance of Protocol knowledge in preventing errors How to not miss "safety Assessments" when you do not know what to look for The Setting up of a site that is prepared for First-in-man studies Who will benefit: Principal Investigators and sub investigators Clinical Research Scientists Research Managers Safety Nurses Clinical Research Associates (CRAs) and Coordinators (CRCs) Recruiting Staff QA / QC auditors and staff Study Monitors Clinical Research Data managers Price List: Live : $245.00 Corporate live : $995.00 Recorded : $295.00 webinars@globalcompliancepanel.com http://www.globalcompliancepanel.com Phone: 800-447-9407 Fax: 302-288-6884 1775 This Webinar goes over the scientific standards of the First-in-Human ("first-in-Man" / FIM) studies and other Phase I studies in the drug development process. 2012-03-06 true http://bit.ly/zVmMKy http://events.boxesandarrows.com/events/1775 http://events.boxesandarrows.com/event/logo/1775/GlobalCompliancePanel_Logo.jpg fim, fim process, first in human, nce, nda studies, new chemical entity, online training, safety assessments Wilmington USA 2012-03-08 Overview : This webinar takes a close look at the consequences of unlawful sexual harassment in the workplace and trains you in how to identify, eliminate and prevent it as part of your best practices strategies. Every state prohibits unlawful sexual harassment in the workplace and almost every employer has certain specific obligations if sexually harassing conduct is even suspected, This webinar takes a look at unlawful sexual harassment and the toll it can take on your workforce and your company's bottom line. You'll learn about the legal definitions of sexual harassment, the significant consequences of sexual harassment, and some of the kinds of conduct that could be unlawful harassment. You'll also learn about your obligations to do prompt and thorough investigations into harassment allegations and to take effective remedial action. Why you should attend: Sexual harassment demeans your company and your employees and it undermines productivity. It also creates significant legal risks. Areas Covered In the Session: The impact of unlawful sexual harassment in the workplace Federal definition of unlawful sexual harassment State sexual harassment law issues Types and elements of sexual harassment claims Types of behavior that could be unlawful sexual harassment Obligations to do prompt and effective investigations and take appropriate remedial action Corporate and personal liability for unlawful sexual harassment Best practices for identifying, eliminating and preventing unlawful sexual harassment Who will benefit: Managers, supervisors and individual contributors at management levels Human Resources professionals (business partners, generalists and functional specialists) Business Owners Administrators and office managers Contract Managers Compliance Professionals 1762 DE Identifying, Eliminating and Preventing Sexual Harassment in the Workplace 2012-03-07 false http://www.trainhr.com http://events.boxesandarrows.com/events/1762 http://events.boxesandarrows.com/event/logo/1762/TrainHR_logo.jpg attorneys, benefits, best practices, business writing, change management, communications and interpersonal skills, compliance, evaluation methods and metrics, hr audits, hr compliance, hr training, hr webinar, innovative methods, internal auditors, law, lawmakers, planning strategies, policy making, presentations skills, regulatory, technology in hr, training development Bristol United Kingdom 2012-03-09 Rolf Molich, co-creator of the heuristic evaluation method (with Jakob Nielson) and the hugely influential CUE studies, will be coming to Bristol in March to share his wisdom in two exclusive workshops. In this first workshop, he covers advanced user testing. Organised by the Bristol Usability Group, this course gives rare insights into the practical doings of usability professionals, normally shrouded behind walls of confidentiality. This course is based on the practical accumulated experience - both good and bad - of the almost 100 professional usability teams who participated in the CUE projects, conducting controlled usability tests in realistic, industrial settings. If you're a usability professional who has conducted a number of tests, here is an opportunity to assess and improve your skills in the key areas of task creation, usability moderation, creating great recommendations, and communicating results. It’s the best tune-up you’ll ever get. 1754 United Kingdom Rolf Molich, co-creator of the heuristic evaluation method (with Jakob Nielson) and the hugely influential CUE studies, shares his wisdom about advanced topics in user testing. 2012-03-08 false http://uxbristolmolich1.eventbrite.co.uk/ http://events.boxesandarrows.com/events/1754 uk, usability, workshop Bristol United Kingdom 2012-03-10 Rolf Molich, co-creator of the heuristic evaluation method (with Jakob Nielson) and the hugely influential CUE studies, will be coming to Bristol in March to share his wisdom in two exclusive workshops. In this second workshop, organised by the Bristol Usability Group, he explores tools and techniques used to measure usability. Qualitative usability testing is by far the most widely used usability method. However, usability practitioners are discovering that they need to accommodate managers who are no longer satisfied with qualitative data and insist on measurements because "You can’t manage what you don’t measure." The current literature on usability measurements aimed at usability practitioners is very limited. This course offers practical information about best practice in usability measurements with real users. The course gives rare insights into how experienced usability professionals do measurements. The course draws upon findings from the recent CUE-8 study where 15 teams including some renowned experts independently tested the same web site under realistic conditions. 1755 United Kingdom Rolf Molich, co-creator of the heuristic evaluation method (with Jakob Nielson) and the hugely influential CUE studies, shares his wisdom about tools and techniques for measuring usability. 2012-03-09 false http://uxbristolmolich2.eventbrite.co.uk/ http://events.boxesandarrows.com/events/1755 uk, usability, workshop 2012-03-14 Auditing of computer systems is important to verify compliance of the systems with regulations and internal standards. When done right, audits 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. Reference material for easy implementation: SOPs: Validation of Commercial Off-the-Shelf Computer Systems Checklist: Using computers in FDA regulated environments Validation templates and examples Areas Covered in the Session: Regulatory requirements: FDA, EU, PIC/S Audit recommendations from the FDA Quality System guidance for cGMPs Effective development and use of audit checklists Developing an SOP for audits of computer systems. Assigning responsibilities Conducting the audit: review procedures, walk through the computer system area Most critical questions to ask Auditing for data integrity Auditing in preparation for FDA's ongoing Part 11 initiative Documenting detailed audit findings The audit summary report Effective follow up Presenting evidence of the audit to the FDA Case study: going through a life audit Who Will Benefit: QA managers and personnel QC and Lab managers IT managers and system administrators Validation specialists Regulatory affairs Training departments Documentation department Consultants Price List: Live : $245.00 Corporate live : $995.00 Recorded : $295.00 webinars@globalcompliancepanel.com http://www.globalcompliancepanel.com Phone: 800-447-9407 Fax: 302-288-6884 1771 This webinar will give a good understanding of FDA and international expectations for auditing computer systems and provide steps for cost-effective implementation. 2012-03-13 true http://bit.ly/wHtoLi http://events.boxesandarrows.com/events/1771 http://events.boxesandarrows.com/event/logo/1771/GlobalCompliancePanel_Logo.jpg audit summary report, auditing computer systems, computer system, international compliance, online training, regulatory requirements 2012-03-14 Overview: This webinar is focused on understanding the requirements of the Medical Device Directives, their linkage to the EU Clinical Trial Directive and the requirements of CE Marking and ISO Certification on commercializing products. Key Topics to be Discussed: The current regulatory situation in relation to Medical Devices in the EU. The purpose of the Medical Device Directives. Meeting the New Requirements for Conformity Assessment by Product Type. Understanding the impact the Directive will have on developing and marketing new Medical Device products. Who will benefit: Clinical research and medical operations Project Managers Product Development personnel Manufacturing personnel Researchers managing Medical Device R&D and Development Quality Assurance such as GMP, GCP Auditors Regulatory affairs Clinical trial supply personnel CRO personnel Price List: Live : $245.00 Corporate live : $995.00 Recorded : $295.00 webinars@globalcompliancepanel.com http://www.globalcompliancepanel.com Phone: 800-447-9407 Fax: 302-288-6884 1766 Changes in the EU Medical Device Directives; 2010 Modifications and the 2012 Recast of the MDD Directives 2012-03-13 true http://bit.ly/AtrB5z http://events.boxesandarrows.com/events/1766 http://events.boxesandarrows.com/event/logo/1766/GlobalCompliancePanel_Logo.jpg current regulatory situation, eu medical device directives, mdd directives, medical device directives, medical device technical file, online training 2012-03-21 What makes this session unique is the combination of step-by-step instructions and the hands on workings of each participant. Bring your laptop and use Excel for your own needs. This session will make you a better Excel user, saving you time and costs. Areas Covered in the Session: Develop spreadsheet applications that are GxP compliant. Avoid 483s and warning letters. What does and does not need to be validated. Learn how to use Excel’s built in 21 CFR Part 11 features. Apply features required for GxP environments without programming macros. Validate your application with minimal documentation. Follow along as we configure Excel for audit trails, security features, data verification, and multiple concurrent users. Who Will Benefit: All Excel users IT QA QC Laboratory staff Managers Executives Price List: Live : $245.00 Corporate live : $995.00 Recorded : $295.00 webinars@globalcompliancepanel.com http://www.globalcompliancepanel.com Phone: 800-447-9407 Fax: 302-288-6884 1769 This interactive webinar provides explicit details and live demonstration followed by a collaborative workshop that explains how to configure and validate a GxP compliant spreadsheet application. 2012-03-20 true http://bit.ly/Alih0J http://events.boxesandarrows.com/events/1769 http://events.boxesandarrows.com/event/logo/1769/GlobalCompliancePanel_Logo.jpg 21 cfr part 11, eliminate 483s, excel spreadsheet validation, gxp compliant, online training, warning letters 2012-03-21 Areas Covered in the Session: When to submit a 510(k) for a new or modified product Types of 510(k) submissions and when to use each What is the submission process What is contained in a 510(k) submission package How to know whether clinical data is required How is the submission package assembled User fees and 510(k) submissions How to interact with the FDA and the reviewer Who Will Benefit: This webinar will provide valuable assistance to all medical device companies that prepare 510(k) submissions. The employees who will benefit include: Executive Management Regulatory Management Professionals involved with premarket notification to the FDA R&D personnel involved in approving the design of medical devices Sales personnel involved in approving the marketing of medical devices Price List: Live : $245.00 Corporate live : $995.00 Recorded : $295.00 webinars@globalcompliancepanel.com http://www.globalcompliancepanel.com Phone: 800-447-9407 Fax: 302-288-6884 1772 This presentation will provide an understanding of how to get a device requiring a 510(k) submission to market quickly. 2012-03-20 true http://bit.ly/A9VFm2 http://events.boxesandarrows.com/events/1772 http://events.boxesandarrows.com/event/logo/1772/GlobalCompliancePanel_Logo.jpg 510k submission, contents requirement, fda, financial health, online training, regulatory management 2012-03-22 Why you should attend: Verification and validation requirements have always been part of the US FDA's GMPs. However, with increasing technology, both industry and regulatory agencies expectations have increased. Recent high-profile field problems indicate that V&V activities are not planned or carried out as completely as expected, and may not be fully utilizing the power of current risk management tools, as identified in ISO 14971. The FDA / ICH Q-series provide valuable insights for all regulated industries, not just Pharma. The billions of dollars spent by industry annually for V&V are not providing the product safety or efficacy seemingly promised. For most companies, the fixes are not rocket-science, but proper up-front V&V planning and execution. Areas Covered in the Session: Verification or Validation - Recent regulatory expectations The Master Validation Plan / structure Product Validation – how it differs from process / equipment V&V Process / Equipment / Facility Validation -- FDA's new guidance When and How to use DQ, IQ, OQ, PQ, or their equivalents How to use Product Risk Management Tools (per ISO 14971 and ICH Q9) The 11 key documents for software validation Incorporating 21 CFR Part 11 requirements Suggested “test case” formats Who Will Benefit: Senior management in Drugs, Devices, Biologics, Dietary Supplements QA RA R&D Engineering Production Operations Consultants Price List: Live : $245.00 Corporate live : $995.00 Recorded : $295.00 webinars@globalcompliancepanel.com http://www.globalcompliancepanel.com Phone: 800-447-9407 Fax: 302-288-6884 1768 FDA Warning Letters and recent high-profile recalls indicate major cGMP deficiencies in many companies. 2012-03-21 true http://bit.ly/wCXC2w http://events.boxesandarrows.com/events/1768 http://events.boxesandarrows.com/event/logo/1768/GlobalCompliancePanel_Logo.jpg 14971 requirements, 21 cfr part 11 requirements, cgmp, ich q9, ich qseries, iso 13485, master verification, online training, us fda, validation planning 2012-03-23 This webinar will examine the existing and proposed requirements for the FDA's DHF -- including its derivative documents, the DMR and DHR. Why you should attend: One of our most popular webinars, updated with 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 Design Dossier. Currently they serve different purposes, support different goals, but the TF/DD is moving in the direction of the DHF. And the DHF is adapting to some of the features of the TF/DD. And how / where do the DMR and DHR fit? Being aware of the similarities and differences can further concurrent development and/or updates to both. Areas Covered in the Session: The U.S. FDA's DHF The EU's MDD and the Technical File / Design Dossier Design Control vs. a Product 'Snapshot in Time' DHF "Typical" Contents The DMR and DHR / Lot / Batch Record TF / DD Expected Contents Parallel Approaches to Documentation -- Teams Future Directions FDA and NB Audit Focus Who Will Benefit: Senior management in Drugs, Devices, Biologics, Dietary Supplements QA RA R&D Engineering Production Operations Marketing Price List: Live : $245.00 Corporate live : $995.00 Recorded : $295.00 webinars@globalcompliancepanel.com http://www.globalcompliancepanel.com Phone: 800-447-9407 Fax: 302-288-6884 1767 This webinar will examine the existing and proposed requirements for the FDA's DHF -- including its derivative documents, the DMR and DHR. 2012-03-22 true http://bit.ly/w3bey9 http://events.boxesandarrows.com/events/1767 http://events.boxesandarrows.com/event/logo/1767/GlobalCompliancePanel_Logo.jpg dhf, dhf typical contents, dhr, dmr, fda, nb audit focus, online training, technical file design dossier, tf and dd expected contents 2012-03-23 Why you should attend: Post market surveillance can be complicated, but by breaking it down into its parts, it can be accessible. With the understanding of the parts, you can develop and implement a comprehensive 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. Areas Covered In the Session: The Structure of Post Market Surveillance US System Complaints (QSR) Medical Device Reports Corrections and Removals International Systems Complaints (ISO 13485) EU Vigilance EU FSCA and FSN Canada Adverse Event Reporting Post Production Information Collection Risk Management (ISO 14971) Clinical Evaluation (MDD Annex X) Who will benefit: Quality Managers Regulatory Affairs Managers Risk Managers Design Control Managers Price List: Live : $245.00 Corporate live : $995.00 Recorded : $295.00 webinars@globalcompliancepanel.com http://www.globalcompliancepanel.com Phone: 800-447-9407 Fax: 302-288-6884 1776 Post market surveillance is changing, not only in the US, but also in the EU and Canada. 2012-03-22 true http://bit.ly/vZbpqr http://events.boxesandarrows.com/events/1776 http://events.boxesandarrows.com/event/logo/1776/GlobalCompliancePanel_Logo.jpg fsca, fsn, iso 13485, iso 14971, mdd annex x, medical devices, online training, post market surveillance, qsr Amsterdam Netherlands 2012-04-27 Day One - Strategy Great design reflects business strategy and vice versa. Principles of strategy may not change, but the practice is constantly evolving. Whether you're working on grand strategy for your product or want a better understanding of the forces shaping your work, this workshop dives into the design & strategy dynamic with new thinking, examples from our experience and hands-on exercises. Day Two - Research You need to make design research count. Valuable research collects information 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 investment. 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. Day Three - Interaction Design It takes more than customer insights and a solid product strategy touccessfully deliver on your customer's expectations. The challenge of transforming research insight and business goals into meaningful and tangible outcomes remains as the primary goal the Interaction Designer. In this session, you'll learn to quickly move from abstract insight, to sketching, prototyping and beyond. Day Four - Digital Service Design Successful product and service experiences are those that have been orchestrated in a way that best considers the changing needs 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 away tools of modeling and analysis that shape smart and systemic solutions. 1752 Netherlands This four-day workshop series is for experienced professionals wanting to take their practice to the next level. We examine the key elements that contribute to a successful interactive experience: Design Strategy, Design Research, Interaction Design and D 2012-04-23 false http://uxiams12.eventbrite.com/ http://events.boxesandarrows.com/events/1752 http://events.boxesandarrows.com/event/logo/1752/uxintensiveprimaryscreen.jpg design, ixd, service design, ux, workshop Melbourne Australia 2012-05-05 1765 Australia Service Design 2012 will be a single day, single track conference, all about designing services for people and organisations. It will be held in early May 2012, in Melbourne, Australia. 2012-05-04 false http://www.uxaustralia.com.au/servicedesign-2012/ http://events.boxesandarrows.com/events/1765 service design Addison USA 2012-06-03 Back for a fourth year, the Big Design 2012 Conference will have talks, panels, interactive booths, art, mixers, parties, and more. Learn from experts like Jared Spool, Stephen Anderson, Sharron Rush, Jeremy Johnson, Brian Sullivan, and 50 other speakers. 1756 TX Join experts in the fields of design, mobile, gaming, usability, strategy, content, multimedia, and film in Big D. 2012-05-31 false http://www.bigdesignconference.com http://events.boxesandarrows.com/events/1756 http://events.boxesandarrows.com/event/logo/1756/Big_Design.png design, usability, ux San Francisco USA 2012-08-25 Adaptive Path's UX Week is the premier user experience conference. With a mix of inspiring talks from recognized thought leaders and hands-on workshops delivering takeaway skills, this event delivers for user experience professionals at all levels — directors, managers, and practitioners. Join us as we celebrate 10 years of UX Week. It just keeps getting better and better! 1753 CA UX Week is the premier user experience design conference. Design professionals from all over the world gather for four days of community, inspiration and skills building. 2012-08-21 false http://www.uxweek.com http://events.boxesandarrows.com/events/1753 http://events.boxesandarrows.com/event/logo/1753/04_Hero.png design, ixd, ux Brisbane Australia 2012-09-01 1763 Australia Four day user experience conference - 2 days of workshops, 2 days of conference 2012-08-28 false http://www.uxaustralia.com.au/uxaustralia-2012 http://events.boxesandarrows.com/events/1763 experience design, strategy, user experience