New Web-based Seminars

Oracle Developer Track 11g This course is for people either new to Oracle database or are trying to learn the new Oracle 11g database version. This instructor led course will take you from Basics to Advanced level of training. At the end you get experience certificate from us.  more...

Call Center Social Media Certification - Live Online - May 9-11 2012 Social media represents one of the most significant changes in consumer media behavior in history, resulting in fundamental shifts in the way companies communicate and interact with consumers. This course provides the practical knowledge and insights required to establish objectives and strategies and to properly select the social media platforms to engage consumers, while monitoring and measuring  more...

Documentum E20-120 Training This training includes: Documentum Fundamentals Documentum Development Documentum Administration. Documentum Foundations Classes, Documentum Foundation Services, Process Builder, Forms Builder. We also give training on Documentum 6. 5 with all new and advanced topics being covered. This is done both in physical and online mode. Trainer are all EMC certified professionals and working in  more...

Documentum 65 Training This training includes: Documentum Fundamentals Documentum Development Documentum Administration. Documentum Foundations Classes, Documentum Foundation Services, Process Builder, Forms Builder. We also give training on Documentum 6. 5 with all new and advanced topics being covered. This is done both in physical and online mode. Trainer are all EMC certified professionals and working in  more...

From Hiring To Firing What Every Manager Needs to Know ... under most state fair employment laws, for example under New York Statea ™s Human Rights Law). This employment law seminar will review the life cycle of employment from hiring to firing and review the impact that each of the employment discrimination laws has on each phase of employment. This employment law Webinar is a must for small employers! A one hour and 15 minute on-line Webinar  more...

Top Tips To Prevent Workplace Violence in your Workplace ... as public employers. It is also fully compliant with the New York State Workplace Prevention Act that requires workplace violence prevention training for all public employers. This Workplace Violence Prevention Training Audio Conference Webinar will provide you with a definition of what constitutes workplace violence and examples of who can engage in workplace violence. It teaches you to  more...

TOP 10 TIPS FOR CREATING A BLOGGING AND SOCIAL MEDIA POLICY ... face of the workplace in America. The explosion of this new method of communication including Twitter, Facebook, My Space, Linkedin and Blogs has raised new legal challenges for employers. These challenges require that HR become even more diligent in developing policies and procedures to avoid liability and protect the employer. Join us for this informative and insightful audio conference  more...

Web Design and Usability Techniques For many new or intermediate Web designers, it ' s difficult to know where to start when designing a site. It ' s easy to make the mistake of assuming that the functionality of a site will take shape over time, or the design will fall into place as you build the site. This web usability training class provides guidance in how to plan and design functional, successful web sites.  more...

Introduction to SQL Training This SQL training course is designed for students new to writing SQL queries. A typical student will need to learn SQL to build applications or to generate business reports. For the most part, the SQL learned in the course is applicable to all major databases. In the few cases in which there are differences between the databases, these differences will be pointed out.  more...

Java Persistence with Spring This course enables the experienced Java developer to use the Spring application framework to manage objects in a lightweight " IoC " (inversion-of-control) container and to manage persistent objects using Spring ' s support for DAOs and transaction control. Spring is a far-reaching framework that aims to facilitate all sorts of Java development, including every level of multi-tier distributed  more...

Spring Web Flow ...complex web applications. Web Flow represents a powerful new approach to designing and developing web applications, and can also draw on the configuration capabilities of Spring itself. We begin with an introduction to the Spring Core module -- which implements the configurable object container available to Web Flow applications as an application context -- and get oriented to the Spring web  more...

QuickBooks 2009 Training ... of a small business. Students will learn how to set up a new company, work with lists, set up inventory, process invoices, work with bank accounts, process payments, enter and pay bills, and use online banking. In addition, students will learn how to customize forms, create reports and graphs, track and pay sales tax, handle payroll, write letters and more. In addition to QuickBooks 2009,  more...

Object-Oriented Analysis and Design (OOAD) Training with UML This Object-Orientated Analysis and Design (OOAD) with UML training course teaches students how to use object-oriented techniques from requirements gathering to implementation. Learn how to analyze and design classes and their relationships to each other in order to build a model of the business requirements. All the UML diagrams are covered in this OOAD class to identify the most suitable diagram  more...

Oracle Database 10g: Administration Level II One of the most challenging tasks ever presented to Oracle database administrators is that of recovery from failure, especially if the recovery must not result in a loss of any data. This Oracle trainig class presents all the standard failure scenarios and the best recovery strategies for each. Strategies for on-line backups, complete and incomplete recovery, media recovery vs.  more...

Introduction to Photoshop CS4 Training In this Adobe Photoshop training course, students new to Photoshop CS4 will learn to use the tool to touch up and modify existing photos and create their own graphics. It is packed with hands-on exercises so that students can learn by doing. This course can also be taught using an older version of Photoshop.  more...

Introduction to MySQL Databases The MySQL training course targets new or existing users of MySQL with some experience with relational database management systems. The MySQL course covers several essential elements of MySQL and general database theories.  more...

MOC 8399 - FRx 6.7 Report Design Essentials I ...e of additional functionality designed to help you create new reports, and distribute and analyze your company ' s financial information. You learn about basic foundational skills, complex calculations, drag and drop reorganization, rounding adjustments and account sets. A thorough understanding of these topics allows you to easily design and maintain standard and essential reports your  more...

MOC 3938 - Updating Your Skills from Microsoft Exchange 2000 Server or Microsoft Exchange Server 2003 to Microsoft Exchange Serv This Microsoft Exchange training class targets Microsoft Exchange 2000 Server or Microsoft Exchange Server 2003 administrators who need to upgrade their skills to manage a Microsoft Exchange Server 2007 infrastructure. This class focuses on the new features and administrative tasks in Exchange Server 2007.Students will learn skills that enable them to deploy and manage an Exchange Server 2007  more...

MOC 5047 - Introduction to Installing and Managing Microsoft Exchange Server 2007 SP1 ... this Microsoft Exchange training class, students who are new to Microsoft Exchange Server will learn how to configure and manage a messaging environment in accordance with technical requirements. Students will learn how to install Microsoft Exchange Server 2007 and manage routing, client access, and the backup and restore of databases. They will also learn how to manage addressing and  more...

Managing Difficult People Training This Managing Difficult People training course teaches students to address difficult people according to their specific behavior. Students will have the opportunity to meet with several Marketing Department team members to address their difficult personalities, follow the guidelines for managing difficult people to decrease the department ' s turnover rate and meet the release date for a new  more...

Java Web Services Training A comprehensive look at the state of the art in developing interoperable web services on the Java EE platform. Students learn the key standards -- SOAP, WSDL, and the WS-I Basic Profile -- and the Java architecture that has evolved to build interoperable services and clients. JAX-WS is central to the course, and we cover both WSDL-driven and Java-driven development paths, as well as message  more...

Introduction to EJB 3.0 This course introduces the experienced Java developer to Enterprise JavaBeans -- the Java EE standard for scalable, secure, and transactional Java components. EJB 3.0 has reinvigorated this area of Java enterprise development, with dramatic improvements in ease of use and smooth integration with servlet-based or JSF web applications. This course treats the 3.0 specification, with a few notes on  more...

Comprehensive JSP Training ...cluding older features such as scriptlets but focusing on newer features and techniques, including JSP expressions and the JSTL. At the end of the course, students will be well prepared to author JSPs for small- or large-scale Web applications, either " by hand " (they use only a text editor in class) or using an authoring tool. The first module begins with an introduction of Web  more...

Ajax Training In this Ajax training course, students learn to make calls to the server with JavaScript and to manipulate XML content returned from the server. Ajax opens the door to creating sophisticated web-based applications with much more of the logic (and therefore code) is handled on the client. While Ajax allows for more dynamic and responsive applications, it changes the traditional role of JavaScript  more...

HTML Training This course is for students new to HTML. It begins with an introduction to web technologies and then provides a comprehensive overview of HTML.  more...

Hibernate Training This course develops skills in using the Object/Relational Mapping tool Hibernate ® . The course uses the latest release version of Hibernate, 3.2, which is directly related to the new EJB 3.0 version defined in Java EE 5.0. By the end of the course, students will be prepared to set-up and use Hibernate as the persistence mechanism in Java applications.  more...

Introduction to Microsoft Excel 2007 Training This Microsoft Excel training course is designed for students new to working with Microsoft Excel 2007. Students will learn to use Excel to create, modify and format Excel worksheets, perform calculations, and print and Excel workbooks.  more...

Introduction to Crystal Reports 2008 Training This Crystal Reports training class is designed for new users of Crystal Reports 2008. Some of the topics covered include a review of the software features, report design and the creation of presentation quality reports. Students get practical experience through plenty of hands-on exercises.  more...

Windows Applications with Visual Basic 2008 Training ...new functionality for the Visual Studio developer. From new language features, including LINQ (Language Integrated Query), to new client-side data support, Visual Studio 2008 and the .NET Framework 3.5 make it easier than ever to create robust, enterprise-level applications. This Visual Basic 2008 Windows Applications training course begins with the basics. Students will become familiar with  more...

Windows Applications with C# 2008 Training ...new functionality for the Visual Studio developer. From new language features, including LINQ (Language Integrated Query), to new client-side data support, Visual Studio 2008 and the .NET Framework 3.5 make it easier than ever to create robust, enterprise-level applications. This C# 2008 Windows Applications training course begins with the basics. Students will become familiar with Windows  more...

Introduction to ColdFusion Training This is an introductory ColdFusion class for Web designers who are brand new to ColdFusion. You will learn to process forms, manage sessions, write reusable code and create database-driven ColdFusion-based websites.  more...

Introduction to Adobe After Effects CS4 In this Adobe After Effects training course, students new to After Effects CS4 will learn to create motion graphics and visual effects. It is packed with hands-on exercises so that students can learn by doing.  more...

Introduction to Active Server Pages ..., database-driven Web sites. This introductory course for new programmers lays out the basics of server-side Web programming with an introduction to classic programming structures and good programming practices. Students will apply these programming skills to the development of a fully functional data-driven website with ASP written in VBScript. Students will harness the power of ASP to  more...

Introduction to Microsoft Access 2003 Training ...Access responsibilities, such as creating and maintaining new databases and using programming techniques that enhance Access applications. It is also for students whose job responsibilities include creating new databases, tables, and relationships, as well as working with and revising intermediate-level queries, forms, and reports. It also introduces the student to integrating Access data with  more...

Introduction to Microsoft Access 2007 Training This Microsoft Access training course is designed for students new to working with Microsoft Access 2007. On the first day, students will learn to create reports in Microsoft Access and manage data in existing databases and to create their own new databases. On the second day of training, students will learn to maintain data consistency, to customize database components, and to share Access  more...

Introduction to Adobe Soundbooth CS3 In this Adobe Soundbooth training course, students new to Soundbooth CS4 will learn to work with audio in film, video, and Adobe Flash software projects.  more...

MySQL Database Design The MySQL training course targets new or existing users of MySQL with some experience with relational database management systems. The MySQL course covers database design theory and several essential elements of MySQL database in general.  more...

Introduction to Microsoft T-SQL Training In this SQL Server training class, you ' ll learn how to build basic queries using Transact-SQL, the language of SQL Server. Then you ' ll learn how to build effective views, stored procedures, triggers, and user-defined functions, using Transact-SQL. You ' ll learn about the new enhancements to the Transact-SQL programming language including improved support for error handling and hierarchical  more...

MOC 4994 - Introduction to Programming Microsoft .NET Applications with Microsoft Visual Studio 2005 This .NET training class enables introductory-level developers who are not familiar with the Microsoft .NET Framework or Microsoft Visual Studio 2005 to gain familiarity with the Visual Studio 2005 development environment. Students will also learn basic skills using either Microsoft Visual Basic or Microsoft Visual C# as a programming language.The target audience for this training class includes  more...

MOC 4994 - Introduction to Programming Microsoft .NET Applications with Microsoft Visual Studio 2005 This .NET training class enables introductory-level developers who are not familiar with the Microsoft .NET Framework or Microsoft Visual Studio 2005 to gain familiarity with the Visual Studio 2005 development environment. Students will also learn basic skills using either Microsoft Visual Basic or Microsoft Visual C# as a programming language.The target audience for this training class includes  more...

Introduction to Microsoft Access 2007 This Microsoft Access training course is designed for students new to working with Microsoft Access 2007. On the first day, students will learn to create reports in Microsoft Access and manage data in existing databases and to create their own new databases. On the second day of training, students will learn to maintain data consistency, to customize database components, and to share Access  more...

MOC 6420 - Fundamentals of Windows Server 2008 Network and Applications Infrastructure This Windows Server 2008 training class introduces students to network and applications infrastructure concepts and configurations provided by Window Server 2008. Students will be able to acquire a fundamental understanding in order to pursue advanced topics available for certification in the network and applications infrastructure areas.This training class is intended for new IT employees or  more...

MOC 6424 - Fundamentals of Windows Server 2008 Active Directory This Windows Server training class provides Active Directory Technology Specialists an introduction to Active Directory server roles in Windows Server 2008. The course is intended for entry level students who want to get familiar with the Active Directory server roles and their basic functionality.This class targets IT Professionals who are new to Active Directory and want to become familiar with  more...

MOC 5119 - Supporting the Microsoft Windows Vista Operating System and Applications This Windows Vista training class provides students with the knowledge and skills to use a Windows Vista operating system image and application package deployment infrastructure to minimize the downtime at the Windows Vista client. Desktop support technicians can use this infrastructure to improve the support experience for new installations, single computer migrations, and single computer  more...

Visual Studio 2008 Training: New Features for Visual Basic Developers ...new functionality for the Visual Basic developer. From new language features, including LINQ (Language Integrated Query) to new client-side data support, Visual Studio 2008 and the .NET Framework 3.5 make it easier than ever to create robust, enterprise-level applications. This Visual Studio 2008 course, including full written courseware, demonstrations, and lab exercises, introduces the most  more...

LINQ Training The .NET 3.5 Framework SDK includes many updates to the C# and Visual Basic programming languages. In this LINQ training course, students will dive into the current Community Technology Preview (CTP) and explore these new programming constructs first hand. Once the core language features have been examined, the remainder of the course will examine LINQ (Language Integrated  more...

ASP.NET AJAX Training with C# 2008 This ASP.NET AJAX training course provides a practical introduction to developing rich Internet applications using ASP.NET AJAX and C#. Because of the rich support provided by Microsoft's AJAX tools, an ASP.NET programmer can get up and running in this new environment quickly. This course shows the way. It is current to ASP.NET 3.5 and Visual Studio 2008.  more...

Visual Studio 2008 Training: New Features for C# Developers ...new functionality for the C# developer. From new language features, including LINQ (Language Integrated Query) to new client-side data support, Visual Studio 2008 and the .NET Framework 3.5 make it easier than ever to create robust, enterprise-level applications. This Visual Studio 2008 course, including full written courseware, demonstrations, and lab exercises, introduces the most important  more...

ASP.NET with Visual Basic 2008 Training This ASP.NET training course teaches students to use Visual Studio 2008 and Visual Basic 2008 to build ASP.NET 3.5 Web pages. You'll gain an understanding of the architecture behind ASP.NET 3.5 and how to use the various ASP.NET 3.5 server controls. You'll learn to create consistent web sites using Master Pages, add membership features, configure and deploy ASP.NET 3.5 applications, to  more...

Certified Sustainability Administrator- Training Start your path to a new career as a Certified Sustainability Administrator (CSA). If you are employed and will be taking on the role of a Sustainability Administrator at your work, or if you are seeking employment to be hired as a Sustainability Administrator or a Green Officer type of job, our training program will benefit you immensely  more...

The Most Important Metrics For Measuring Supply Chain Performance ...alue Fill Rate These supply chain metrics, PLUS a few new metrics (like DPMO: Defects per Million Opportunities) brought to us by the Six-Sigma world, will be presented and discussed in this live and interactive 90-minute webinar. The a Modem Chat Seriesa Webinar leader will explain each of these common metrics and demonstrate how each is calculated. Participants will be encouraged to  more...

JIRA Workflow Administration Webinar The JIRA Workflow Administration training course covers all administrative features of JIRA related to customisation of the workflow and data capture. Attendees from this session will become proficient with creation of custom fields, new issue types, workflow statuses, transitions, post functions, field configurations, mandatory fields, hidden fields, workflow schemes and applying a JIRA workflow  more...

How to Achieve Maintain ERP Systems Master File Data Integrity ...n integrated information systems have created an entirely new management responsibility monitoring the condition of the data necessary to the decision making process itself. No longer is a manager responsible solely for reporting economic results and departmental performance. Today's manager must measure, monitor and report the condition of data utilized in the decision making process much  more...

Integrative Activity Based Costing Leadership An Overview of Bottom Up Cost Accounting ...ts. With some commonly used value engineering tools, a new perspective of product cost can be developed. 2. To demonstrate how any standard cost accounting system can be made to calculate allocations based on activities instead of labor dollars. 3. To provide executives with an overview of how ABCA can motivate all levels of employees to self-identify, self-prioritize and  more...

A Better Method for Rationalizing Capital investmentsTools for Calculating REAL Investment Value ...ers continue to struggle with the best way to rationalize new investments in capital equipment. Interestingly enough, this struggle is often the result of failed cost accounting systems and methods. It is these systems that fail to provide accurate information that ultimately allow an investment to be appropriately modeled within the context of the entire organization. We will present a  more...

Early Intervention Field Trauma Training ...covery stages, fitting interventions to client needs, the new Educate, Assess and Refer (EAR) Field Trauma Response model, Reactions and Response to CBRN Terrorism, steps to lessen crisis impact, utilization of community resources for prevention/ resolution. In addition, Compassion Fatigue risk factors, symptoms and prevention/ self-care strategies will be addressed. This course is both  more...

Better Methods for Calculating Safety Stock Service Levels This FREE 1-hour webinar addresses some techniques for reducing safety stock and still meeting target customer service levels. Specifically, this program will present some new ideas in safety stock and service level management by utilizing a unique modeling instrument that simulates safety stock, service levels, stock-outs and inventory investment from a random stream of demand over multiple  more...

Keeping Work Order and Purchase Order Due Dates Accurate - A Key to Production Planning Success Does your company, at this very moment, have past due work orders or purchase orders? Does your company utilize a priority planning system (MRP, KanBan, etc.) to manage the flow of materials through the factory? Does your company have a materials management organization that responds to expedite activity more than to planned activity? This FREE 1-hour webinar will present some new thoughts and  more...

Three New Segmented P and Ls That Will Shake Your Understanding of Product Cost This 1-hour FREE webinar presents three new profit and loss statements that are the direct result of rethinking manufacturing cost accounting. These new formats are sure to forever change your thinking about how value is created... and destroyed... in a manufacturing enterprise.  more...

New Final HIPAA Amendments New final rules for HIPAA Expand the Scope and Increase Responsibilities ... forward, in order to be prepared for compliance with the new regulations. It will provide a comprehensive look at the changes in the law and prepare attendees for the process of incorporating the changes into how they do business in their facilities. Areas Covered In the Session: The new regulations will be reviewed and their effects on usual practices will be discussed, as well as what  more...

Supply Chain Risk Management - Webinar By GlobalCompliancePanel Overview: For the last decade, there has been an extensive and organized effort by organizations to assess their risks, especially in financial services. Non Financial firms are now increasing their risk management especially in the light of such complex, global, and out sourced supply chains. The new ISO 31000 and ISO 31010 frameworks provide guidelines in this process that make good sense and  more...

Drug Development Process - From Discovery to Marketing - Webinar By GlobalCompliancePanel This webinar will provide a clinical and regulatory perspectives on requirements to take a new drug from research to market. Wednesday, February 15, 2012 10: 00 AM PST | 01: 00 PM EST  more...

Verification of Compendial Methods according to the New USP Chapter 1226 - Webinar By GlobalCompliancePanel This webinar will give a good understanding of USP and FDA requirement and provide recommendations and tools for effective implementation. Thursday, January 12, 2012 10: 00 AM PST | 01: 00 PM EST  more...

Supply Chain Integrity and Security - Webinar By GlobalCompliancePanel ...opic of supply chain integrity and security is relatively new in Pharma, having gained prominence in recent years for the reasons described above. Breach of security related to criminal activity is where the issues are most visible and enforcement activity is actively taking place around the globe. In parallel, if we are looking for sustainable, root cause solutions, we must also turn our  more...

21 CFR Part 11 and Annex 11 What you Need to Know to Pass the New Regulatory Audits - Webinar GlobalCompliancePanel This webinar details both regulations and provides details for implementing computerized systems. Tuesday, March 6, 2012 10: 00 AM PST | 01: 00 PM EST  more...

FDAs Revised Draft Guidance on Medical Device Changes and the 510k - Webinar By GlobalCompliancePanel This webinar will discuss the new draft guidance document from the FDA: "510(k) Device Modifications: Deciding When to Submit a 510(k) for a Change to an Existing Device", dated July 27, 2011. Wednesday, January 25, 2012 10: 00 AM PST | 01: 00 PM EST  more...

Dietary Supplement Regulatory Compliance in the United States Labeling Product Claims Updates from the FDA - Webinar By GlobalC This 90 minute live, interactive webinar will review the dietary supplement regulations and discuss how to verify that your products are compliant, while citing differences with food and drug regulations. We will also cover what qualifies a material as a dietary ingredient, considerations for manufacturers and distributors, requirements for compliant labeling and acceptable marketing claims. An  more...

Risk Management in IEC 60601-1 Third Edition - Webinar By GlobalCompliancePanel ... 60601-1 Third Edition was released in late 2005. It is a new philosophy in standards for medical electrical devices to accommodate rapid advances in technology. This new philosophy has been difficult for test houses and compliance bodies to absorb and develop test strategies. Currently, the EU and Canada have announced May 31-June 1, 2012 as the date when the Second Edition will be  more...

What is New in Ultrasonics Exploring Piezoelectric Technology - Webinar By mentorhealth Ever wonder what "the Piezo" is all about? What makes it so different from "the Cavitron"? This course is designed to examine the unique capabilities of piezoelectric ultrasonics and the role micro-ultrasonics play in contemporary periodontal therapeutics. Discussion of hand scaling versus power scaling will be explored, as well as an overview of the various piezoelectric ultrasonic devices  more...

New Process Validation Life-Cycle Approach - Apply statistical tools to demonstrate Process Capability - Webinar By GlobalCompli This webinar will describe the new Process Validation Life-Cycle Approach as defined in the revised FDA guideline. The three stages will be described in detail including: Process Design, Process Qualification and the Continued Process Verification. Thursday, December 15, 2011 10: 00 AM PST | 01: 00 PM EST  more...

New Amendments of Critical Parameters in Canadian Clinical Trials - Webinar By GlobalCompliancePanel This presentation will help you to understand the last changes that occurred in Canadian ethics regulations. The presentation will clarify for sites and sponsors how to easy the ethics process and how to get more quicker the ethics approval. Also after the presentation the participant will understand how to apply the last changes in ethics regulation in the day-to-day work. Every member of the  more...

21 CFR Part 11 and Annex 11 What you Need to Know to Pass the New Regulatory Audits - Webinar By GlobalCompliancePanel This webinar details both regulations and provides details for implementing computerized systems. Tuesday, December 6, 2011 10: 00 AM PST | 01: 00 PM EST  more...

Working with the Pharmacopeias and Compendia - Webinar By GlobalCompliancePanel Every developed country has a pharmacopeia, including the European Union. This webinar will explore the function that the pharmacopeias play in the regulation and quality control of pharmaceutical products. The pharmacopeias play a key role in setting standards for individual pharmaceutical products. These standards are both for the physico-chemical properties of pharmaceuticals and for the  more...

Calculating Overtime Correctly - Webinar By TrainHR ...ion do they? According to the Department of Labor, 300 new wage and hour investigators were hired in 2009 to respond to complaints and violations. By the end of 2010 the DOL announced they had collected more than $300 million in back wages for more than 385, 000 workers. Penalties for overtime violations can be severe with the possibility of fines, imprisonment or both! Add civil suits to  more...

Specializing in Treating the Phobic Patient - Webinar By mentorhealth Treating the phobic patient is analogous to the clinician acquiring a new skill like implantology. It requires knowledge of the three primary medications used; the indications and contraindications. The only financial investment will be a pulse-oxymeter (to monitor vital signs during treatment). Tuesday, October 18, 2011 10: 00 AM PDT | 01: 00 PM EDT  more...

2012 New and Changed ICD-9- CM Codes - Webinar By mentorhealth Don't miss this opportunity to learn about all of the ICD-9-CM changes for 2012. It is imperative that all coders stay current on changes in the official ICD-9-CM codes and be prepared to implement those changes by October 1st. Wednesday, October 5, 2011 10: 00 AM PDT | 01: 00 PM EDT  more...

Dispel the Loss Leader Myth Blueprints to Increase Hygiene Department Services and Production - Webinar By mentorhealth You've tried getting new patients to fill the holes in your hygiene schedule....now its time for a new approach! Fill the holes with your existing patients by learning how to treatment plan non-surgical cases. Thursday, October 13, 2011 10: 00 AM PDT | 01: 00 PM EDT  more...

HIPAA Privacy Policies and Procedures Prepare for Updates and New Requirements - Webinar By mentorhealth Learn how having good policies and procedures and good documentation can make compliance easier. Thursday, October 6, 2011 10: 00 AM PDT | 01: 00 PM EDT  more...

ITIL v3 Service Operation Virtual Instructor Led ...ovides you with an intense and focused exploration of the new and updated topics in ITIL ® v3 from the point of view of the owner of a process or set of activities. The course is intended for those who work within a Service Operation (SO) environment and require a deeper understanding of the underlying concepts, processes/ functions and activities involved and management responsibilities  more...

The Investigational Device Exemption When is it Needed and How is it Obtained Most Easily - Webinar By GlobalCompliancePanel We will discuss the situation of the "sponsor/ investigator," where a person doing research is sponsoring the research as well. This might be a physician who has designed a new instrument to be used in his practice, or an inventor doing a preliminary evaluation of his invention using human subjects. The situation in which a physician uses a legally-marketed device for a purpose other than that  more...

ITIL V3 Foundation This four-day Live Instructor-Led online course provides you with an intense and focused exploration of the new and updated topics in ITIL ® v3. The course is intended for those who work within IT or wish to explore IT service management frameworks and how they may be used to enhance overall service quality and service provision.  more...

Designing an Effective Cleaning Validation in todays Regulatory Environment - Webinar By GlobalCompliancePanel This webinar concentrates on designing effective cleaning validation studies. Key benefits of this seminar include: Learn what steps should be followed. Identify critical parts of cleaning validation process. Achieve satisfactory inspections. Higher assurance of new medical product approvals. Minimize nonconformances. Reduce rates of batch rework and rejections. Avoid product recalls.  more...

The Drug Development Process - From RD to Commercialization - Webinar By GlobalCompliancePanel In today's fast-paced, highly regulated and risk-aversive environment, functional groups can no longer work in isolation, but must collaborate extensively to design, develop, manufacture, test, validate and commercialize new drugs. Successful commercialization depends on effective processes to bring both the drug supply manufacturing processes and controls as well as the associated data and  more...

Intelligent Routing for Temperature Sensitive Goods - Webinar By GlobalCompliancePanel The session will cover strategies to provide real-time cold chain temperature tracking and traceability.  more...

SAP FICO Online Competency Development Training program ...cument number ranges/ Document Type/ Document Posting 6. New General Ledger 7. G/ L account creation/ change/ display/ blocking & unblocking/ balance display 8. Document display/ change/ changed documents display/ holding/ parking/ reversal 9. individual/ mass/ accrual /deferral cleared item reversal 10. Sample/ recurring documents/ interest calculation/ foreign currency valuation 11.  more...

JAVA J2EE JEE Professional Role Based Training from Zaran Tech ...s and programmers interested in expanding their role into new Technology. Here are some videos explaining how we conduct our training program, use Training Blogs and Google documents to communicate with our trainees and share the Assignments, Video Recordings, Training documents, Training materials for our training program, (each video is less than 5 min long but gives you a good idea about  more...

Establishing a Reduced Testing Program for Pharmaceutical Medical Device Components Reduced testing test permits a medical product manufacturer to reduce testing of incoming components provided there are adequate controls on specification control, material qualification, supplier qualification & monitoring, material validation, and collaborative testing. Industry practice in the performance of reduced testing has resulted in new and modified expectations and requirements.  more...

HIPAA Accounting of Disclosures Expanded scope in proposed rule means new obligations The session will walk the listener down the path from the current HIPAA Accounting of Disclosures rule, through the HITECH Act's required changes, and the into the proposed rule to implement HITECH which goes beyond what was required in the law and establishes a new right to an Access Report of all electronic PHI.  more...

HIPAA Accounting of Disclosures Expanded scope in proposed rule means new obligations by gcp The session will walk the listener down the path from the current HIPAA Accounting of Disclosures rule, through the HITECH Act's required changes, and the into the proposed rule to implement HITECH which goes beyond what was required in the law and establishes a new right to an Access Report of all electronic PHI.  more...

HIPAA and Security Breaches Most frequent issues and causes and trends for future threats by GCP The HIPAA Breach Notification Rule has been in effect since September 23, 2009 and most organizations are not prepared to respond to a breach of PHI and report and document it properly. We will discuss the origins of the rule and how it works, including interactions with other HIPAA rules and penalties for violations  more...

21 CFR Part 11 and Annex 11 What you Need to Know to Pass the New Regulatory Audits This webinar details both regulations and provides details for implementing computerized systems  more...

New Perspectives on Leadership by TrainHR Few topics in management generate as much interest as the topic of Leadership. The abiding preoccupation with this subject is reflected not only in the substantial amount of academic research whose objective is to understand the secrets of successful Leadership.  more...

Auditing and Administrating Human Resources Policies and Practices by TrainHR ...arify policies for easier administration, and perhaps add new policies others to address new situations and circumstances in your workplace. Well thought out and clearly written HR policies provide comprehensive, consistent communication, reduce conflict , convey legal obligations, protect your company by covering employer rights, notify employees of recourse systems, clarify expectations,  more...

Effective Employee Performance Documentation Elements and Techniques by TrainHR Communicate better, improve performance, and defend yourself from legal challenges by producing more effective performance documentation. Employees are more productive when they know what is expected of them. Employee discipline is easier when documents are in order, and high standards are met when directions are clear. Learn simple, stress-free methods for collecting the right information,  more...

HIPAA and Electronic Health Records Meeting the new requirements and new regulations - Webinar By GlobalCompliancePanel The new and proposed HIPAA Privacy and Security regulations will be reviewed and their effects on the use of EHRs will be discussed. The proposed rules call for an ability to make an electronic copy of an individual's protected health information for any information held in an entity's designated record set.  more...

How to Create Configure and Manage a Design Inputs - Design Outputs Traceability Matrix utilizing the principles of Lean Documen ...ration to avoiding these errors, while presenting a fresh new approach to these key and related documents. Why you should attend: Do you find yourself constantly struggling to create, manage, and maintain all of the information found in Design Inputs, Design Outputs, and traceability matrices - which is often redundant, repetitive, and chained together in a cumbersome way? Do you find that  more...

Creation and management of a Controlled Document System for a Life Sciences manufacturing plant utilizing the principles of Lean Controlled documents are one of the foundational building blocks of a Quality Management System (QMS) for regulated industries. Too often, controlled documents are cluttered, confusing, and cause many errors due to the way they are created, organized, and managed. This webinar applies the Theory of Lean Documents and the corresponding Theory of Lean Configuration to this key part of a QMS.  more...

Failure Mode Effects Analysis FMEA - The Tool of Choice to Improve Product and Process Reliability and Efficiency While Reducin Failure Mode and Effects Analysis is a tried an proven technique to improve the quality, reliability and safety of products and processes in a proactive manner. It has been used successfully for over 60 years in very type of industry and in all stages of product development, process improvement projects. It helps to increase customer satisfaction, by proactively addressing failures that keep us  more...

Understanding and Implementing USP 1058 Analytical Instrument Qualification - Webinar By GlobalCompliancePanel ...Despite the fact that instrument qualification is nothing new and companies spend a lot of time, it is a frequently cited deviation in FDA inspectional observations and warning letters. Companies are unsure on what exactly to qualify or re-qualify, test and document. The main reason is that unlike for analytical methods there are no clear standards for equipment qualification. This has  more...

The Risk to Subject Safety of Not Accurately Reporting Adverse Events - How to Assess and report AEs and SAEs - Webinar By Globa The principal objective in a new drug development program is to assess the benefit / risk ratio. Learn what the risk information is that must be collected, documented and reported accurately.  more...

Device Changes and the 510k - Webinar By GlobalCompliancePanel ...rocess. The FDA holds companies responsible for filing new 510(k)s when one change is major enough to impact safety / effectiveness, or when a series of lesser changes finally reach the "tipping point". This is a major headache. How can companies make that determination? How can they trigger such an analysis over the major change or the series of smaller changes. What approaches are required  more...

Introduction to Risk Management - This three hour overview of financial risk management will provide the fundamentals to risk management that all managers need to comprehend. Regardless of job titles, risk management is a shared responsibility by all managers. Compared to accounting, risk is an immature discipline with a variety of risk frameworks competing to dominate. Based on the new Wiley and Sons book, Essentials of Risk  more...

Introduction to Risk Management - Webinar by GlobalCompliancePanel This three hour overview of financial risk management will provide the fundamentals to risk management that all managers need to comprehend. Regardless of job titles, risk management is a shared responsibility by all managers. Compared to accounting, risk is an immature discipline with a variety of risk frameworks competing to dominate. Based on the new Wiley and Sons book, Essentials of Risk  more...

Human Behavior in Cleanrooms and Controlled Environments - Webinar By GlobalCompliancePanel his live webinar concentrates on identifying good and bad cleanroom behavior. It provides training in cleanroom contaminants and how they are affected by humans. The key benefits of this course are: In-dept understanding of cleanroom contaminants. Achieve satisfactory inspections more easily. Higher assurance of new medical product approvals. Minimize nonconformances.  more...

Introduction to Master Validation Plans - Webinar By GlobalCompliancePanel This webinar provides an introduction to the creation, implementation, and maintenance of Validation Master Plans. Key benefits of this seminar include: Achieve satisfactory inspections more easily. Higher assurance of new medical product approvals. Minimize nonconformances. Reduce rates of batch rework and rejections. Avoid product recalls. Take a holistic  more...

HIPAA Enforcement and Compliance Audits What the auditors want and how to be ready before they call - Webinar By GlobalComplianc ...s and their recent changes that increase fines and create new penalty levels, including new penalties for willful neglect of compliance that begin at $10, 000. 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  more...

Information Security Risk Analysis Meeting HIPAA Requirements and the Meaningful Use Objective - Webinar By GlobalCompliancePane ...d what the penalties are for not complying, including the new penalties for willful neglect of compliance, which begin at $10, 000. * See how the risk analysis requirement for meeting the privacy and security objective of meaningful use, necessary for federal funding, fits in with HIPAA compliance. * Learn what steps to follow in the discovery and organization of information needed  more...

The GCPICH Obligations of Sponsors Monitors and Investigators - barriers and solution - Webinar By GlobalCompliancePanel ...new drug development program is to assess the benefit / risk ratio. Learn what the risk information is that must be collected, documented and reported accurately. Learn also how the International Conference on Harmonization (ICH) has been the most outspoken as to what GCP is including a formal listing of the "Principles of GCP" and a definition that is clear. Covered also will be what the  more...

Pharmaceutical and Medical Device Validation Guidances - Similarities and Differences - Webinar By GlobalCompliancePanel Overview: This webinar will provide an overview of process validation for devices and pharmaceuticals. While most of the webinar will include FDA compliance requirements, there will be some International Standards Organization (ISO), European, and Canadian regulations included for exploration. After attending this webinar, attendees will have a greater perspective of process validation and its  more...

Developing the Master VV Plan to Meet US FDA ISO 13485 and 14971 Requirements - Webinar By GlobalCompliancePanel ... * 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  more...

The Most Common Problems in FDA Software Validation Verification- Webinar By GlobalCompliancePanel ...e inspections..." The statement clearly reflects the renewed FDA interest in examining industry compliance with regulations for electronic records and electronic signatures - and its willingness to aggressively pursue enforcement actions. This FDA Software Validation and Verification (V&V) training/ webinar will review the validation planning process with particular emphasis on avoiding most  more...

Data Security Analysis for Healthcare Providers - Webinar By GlobalCompliancePanel ...and security analysis obligations are under HIPAA and the new "meaningful use" rules under the HITECH Act. Attendees will receive questionnaires and checklists that can be adapted for use by a healthcare provider to conduct a targeted risk analysis and meet HITECH and HIPAA requirements. Areas Covered in the Session: * "Meaningful Use" data security analysis requirements * HIPAA  more...

Understanding Attribute Acceptance Sampling including Z14 and c0 Plans -- Webinar By GlobalCompliancePanel ...e doesna ™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 isna ™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  more...

Facilities Cleaning in Cleanrooms and Controlled Environments - Webinar By GlobalCompliancePanel ...ctory inspections more easily. * Higher assurance of new medical product approvals. * Minimize nonconformances. * Reduce rates of batch rework and rejections. * Reduce cleaning-related environmental contamination issues. * Avoid product recalls. * Understand industry standards in cleanroom cleaning Why should you attend: Cleanroom cleaning processes and methods  more...

Calibration and Qualification in Analytical Laboratories - Webinar By GlobalCompliancePanel ...t that equipment calibration and qualification is nothing new and companies spend a lot of time, it is a frequently cited deviation in FDA inspectional observations and warning letters. Companies are unsure on what exactly to qualify test and document. For easy implementation, attendees will receive: * 4 SOPs o User Requirement Specifications (URS) for analytical equipment  more...

Navigating the Regulatory Environment for the Implementation of Alternative Microbiology Technologies - Webinar By GCPanel ...ed in a previously approved regulatory dossier, such as a New Drug Application (NDA) or Marketing Authorization. There are different perspectives on RMM validation, submission and implementation strategies, depending on the regulatory body your products are registered with, and/ or which local inspectorate is responsible for conducting GMP audits at your manufacturing facilities. Rapid  more...

Validation of ExistingLegacy Computer Systems for FDAEU Compliance - Webinar By GlobalCompliancePanel ...the industry is very well familiar with the validation of new systems, there are many questions about existing or legacy systems. This web seminar will give a good understanding on the regulatory requirements, and it will have recommendations and provide tools for effective implementation. Reference material for easy implementation: * SOP: Retrospective Validation of Computerized  more...

HIPAA Business Associates How the regulations have changed and what you need to do for compliance now - Webinar By GCPanel ...ss Associate rules have changed in fundamental ways, with new responsibilities and obligations for HIPAA BAs. The session will provide attendees the following tools, benefits, and solutions: * The audience will learn how business associates are now handled under the law and the proposed regulations and what has changed from the old rules. * The suggested and required content for  more...

HIPAA Breach Notification What to do to prevent breaches and what to do when they happen to you - Webinar By GCPanel ...new HIPAA Breach Notification Rule required by the HITECH Act within the American Recovery and Reinvestment Act of 2009 went into effect September 23, 2009, requiring all HIPAA covered entities and business associates to follow a number of steps to be in compliance. * The HIPAA Breach Notification Rule has been in effect since September 23, 2009 and most organizations are not prepared to  more...

FDAs New Process Validation Guidance - Webinar By GlobalCompliancePanel ...uthorities and CDER's sister medical device division. The new requirements expand validation from a one-time activity into a full lifecycle philosophy, encompassing statistics, risk management, project management, and new technologies. No one involved in process development and validation in the drug, API, or biologics industries (or their vendors!) can afford to miss this presentation; while  more...

Validating Rapid Microbiological Methods - Webinar By GlobalCompliancePanel ...tion program in order to effectively demonstrate that the new RMM is suitable for its intended use and is equivalent to, or better than, the existing method you intend to replace. Topics will include the development of User Requirements Specifications, the validation master plan, IQ, OQ and PQ expectations, and a comprehensive review of how to utilize USP Chapter 1223, Ph. Eur. Chapter 5. 1.6  more...

Efficient Computer System Validation - 10 Easy Steps - Webinar By GlobalCompliancePanel ...zed documentation and ensures efficient implementation of new and upgraded computer systems. This experience will prepare you to perform a validation project. Areas Covered in the Session: * Learn which documents the FDA expects to audit. * How to use the risk-based validation approach to lower costs. * How to link requirements, specifications, risk management, and testing.  more...

The Investigation System Discovery Planning Root Cause Analysis CAPA - Webinar By GlobalCompliancePanel Overview: This program is intended for those personnel who are concerned with the analysis and correction of problems (deviations and failures). This course provides clarity to the regulatory expectations and guidance, and to the essential skills necessary to ensure effective and efficient investigations. Topics will examine each step of the investigation process from failure identification and  more...

Food Drug Cosmetic Act Implementing Regulations Major New Laws - An Overview - Webinar By GlobalCompliancePanel ... industries that have followed. Some more recent major new regulations such as the Dietary Supplement Health & Education Act (DSHEA), the Bioterrorism Act, and the Food Safety Modernization Act will also be covered. Areas Covered In the Seminar: * History of the Food, Drug & Cosmetic (FD&C) Act * Amendments to the Food, Drug, & Cosmetic Law * Overview of Major Regulatory  more...

Design Control for Medical Devices - Webinar By GlobalCompliancePanel ...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 so unwieldy as the present a barrier to timely market introduction. This webinar will cover the basics of design controls, and provide  more...

Purchasing and Supplier Controls in the Medical Device Industry - Webinar By GlobalCompliancePanel ... Areas Covered In the Seminar: * How to qualify new suppliers in a cost efficient manner * How to assess current suppliers in a cost efficient manner * How to perform supplier-related corrective action * Minimum documentation requirements for supplier qualification, assessment, and related corrective action Who will benefit: This webinar will provide valuable  more...

XML Training ...Changes Makes Your Data More Available Used to Create New Internet Languages 4. VIEW AND EDIT XML FILES Sample XML file Viewing XML files List of Browsers Editing XML files Free XML editors 5. XML DOCUMENT STRUCTURE Sample XML document XML Tree XML Syntax Comments in XML Special characters Parts of an XML document XML Prolog 6. XML FAMILY TREE What  more...

Meet FDA Expectations for a Tougher Supplier Audit Program - Webinar By GlobalCompliancePanel ...FDA has been ineffective in protecting the public. Recent news events seem to support this perception. The FDA is working hard to change that perception. Industry must be prepared to adapt, and recognize that such adaptation will actually work to their long-term benefit. This webinar will discuss and evaluate the effects that this call for change has on a company and its selection, audit,  more...

Developing and Using the Product Risk Management FileReport - Webinar By GlobalCompliancePanel ...A. These activities can also be used as a method to train new hires, especially in Marketing, QA/ RA, Engineering, and Manufacturing. This webinar will address the procedures, provide and discuss suggested templates, necessary to develop or modify and then use the ISO 14971 and Q9 models to perform and document such activities for any medical product. It will examine the additional actions  more...

Change Control -- Your Companys GMP Weak Point - Webinar By GlobalCompliancePanel ... has been ineffective in protecting the public. Recent news events in foods, drugs, and devices seem to support this perception. The "tougher" FDA is determined to change that perception. Industry must be prepared to adapt, and recognize that such adaptation will actually work to their long-term benefit. This webinar will discuss and evaluate the effects that this call for change has on a  more...

Tougher US FDA cGMP Compliance Audits - When Youre Not Ready - Webinar by GlobalCompliancePanel ..., and recent public concern over insufficient oversite of new product introductions (and grandfathered product) by means of the 510(k) system. Business continues to "shoot itself in the foot", including once highly respected companies. All this affects the Agency's approach to audits and their expectations for companies. They also use GMP compliance audits to drive companies to do much of their  more...

Introduction to Investment Risk - Credit Market and Portfolio - Webinar by GlobalCompliancePanel ...ty of risk frameworks competing to dominate. Based on the new Wiley and Sons book, Essentials of Risk Management, (January 2010), this webinar is designed to provide an introduction to an area and discipline that is changing rapidly, especially in the light of the risk management failures that have shattered so many personal and professional. Why you should attend: To avoid repeating the  more...

Introduction to Contamination Control Master Plans - Webinar by GlobalCompliancePanel ...actory inspections more easily * Higher assurance of new medical product approvals * Minimize nonconformances * Reduce rates of batch rework and rejections * Avoid product recalls * Identify and control the key contamination concerns for your company * Take a holistic approach to contamination control * Achieve synergy among control programs Why you should  more...

Cleanroom HEPA Filter Testing Certification An Owners Guide - Webinar by GlobalCompliancePanel ...actory inspections more easily * Higher assurance of new medical product approvals * Minimize nonconformances * Reduce rates of batch rework and rejections * Avoid product recalls Why you should attend: Regulatory agencies expect manufacturers to periodically demonstrate that cleanrooms and controlled environments perform according to their design specifications. In  more...

Understanding the Technical Requirements of 21 CFR Part 11 - Webinar by GlobalCompliancePanel ...Why should you attend: With the announcement in 2010 of a new Part 11 Inspection initiative, life science organizations can expect to see a higher level of scrutiny of the compliance of computerized systems utilized for regulated activities. To avoid any regulatory observations on your automated systems, it is important to ensure that compliance is built into those system from inception. This  more...

International Financial Reporting Standards The Basics - Webinar by GlobalCompliancePanel ...ional you need to become familiar with exactly what these new International Financial Reporting Standards consist of, and what these changes mean for companies. Areas Covered in the Session: * GAAP vs. IFRS * What will change * What will not change * Who needs to comply * The four key principles of IFRS * How disclosure requirements will change * The new  more...

Medical Device Changes and The 510k - Webinar By GlobalCompliancePanel ...ing product having an existing 510(k), for the need for a new 510(k). Such a review takes on added urgency as a result of the stated intent of the Agency to get tougher across the board in its expectations for the medical industry and what it (the FDA and industry) need to do to "toughen" the 510(k) process. A review of recent information from the Agency, including last summer's Working  more...

Project Management in a cGMP Environment - Webinar By GlobalCompliancePanel ...ntation of Project Management Planning and Techniques for new product development, regulatory compliance audit responses, proof of "progress against plan", and other activities requiring a planned documented rationale. Three of the most common tools will be discussed. One very simple approach using common Excel- or Word-type PC applications programs that can be used immediately. Regular use  more...

Effective Training Practices for FDA Compliance - Webinar By GlobalCompliancePanel ...resentation will answer some of the frequent questions of new trainers or training managers. These include: worker training requirements, the frequency of training, how do design an effective training program, who is responsible for training, training effectives and training documentation. By examining the GMP expectations on training from different regulatory bodies (from the regulations  more...

Preparing for GFSI and other Third Party Audits - Webinar By GlobalCompliancePanel ...nies are losing current accounts and are denied access to new accounts and business. Many organizations are new to the process of audits and associated standards. Thus, they are seeking out expensive consultations and/ or are requesting pre-assessments to prepare for audits. In order to work cost effectively, allocating resources and dollars to professional help with developing better systems  more...

Complying with HIPAA Security Rules Whats in the rules and how you can most easily prepare for compliance - Webinar By GlobalCom ...y because of inadequate security practices. Now there are new, increased penalties for HIPAA violations and a new auditing process is being developed so that HIPAA covered entities will be subject to reviews by the US Department of Health and Human Services' Office for Civil Rights even if no one files a complaint. If you haven't done whata ™s required under the HIPAA Security Rule, you  more...

Electronic Raw Data in Regulated Environments - Definition Recording and Archiving - Webinar By GlobalCompliancePanel Overview: All regulations have strict requirements for electronic raw data and other e-records. The objective is to ensure accuracy, integrity, authenticity, security and availability of records during the entire life from generation to deletion. While the intent is the same for all regulations only FDA's 21 CFR Part 11 and the EU equivalent Annex 11 have well defined requirements but still  more...

Operational Risk Management Ensuring Safety for Food Systems - Webinar By GlobalCompliancePanel ...abilities associated with recalls and deaths are creating new approaches to determine and reduce the likelihood of risks associated with contaminated foods. Risk assessment involves determining where and what types of risks are involved throughout any food process, assigning quantitative values to those risks, measuring the processes based on risk factors and ranking risk areas for purposes  more...

Designing and Implementing the Quality System for Combination Products - Webinar By GlobalCompliancePanel Overview: The FDA generally defines combination products as a product composed of any combination of a drug and a device; a biological product and a device; a drug and a biological product; or a drug, device, and a biological product. Although there are differences between these quality systems, the quality principles embodied in the systems are the same. This course looks at these principles  more...

How to Prepare and Submit a Bullet Proof 510k and Latest FDA Proposed Changes to the Process - Webinar By GlobalCompliancePanel ... and Abbreviated 510(k) methods were developed under the "New 510(k) Paradigm" to help streamline the 510(k) review process. Product modifications that could significantly affect safety and effectiveness are subject to 510(k) submission requirements under 21 CFR 807 as well as design control requirements under the Quality System (QS) regulation. Under the QS regulation, all Class II and III  more...

New Changes to HIPAA The latest changes in the regulations and what they mean to you - Webinar By GlobalCompliancePanel ...New regulations modifying the HIPAA Privacy and Security Regulations have been proposed and/ or finalized to meet the privacy and security mandates within the HITECH Act in the American Recovery and Reinvestment Act of 2009. New requirements for business associates of HIPAA covered entities and requirements to notify individuals in the event of a breach are only two of the many areas  more...

Understanding and Preparing for FDAs New Part 11 Inspection Program - Webinar By GlobalCompliancePanel ...earning from past Part 11 inspections * Scope of the new Part 11 program: time frame, expected outcome * Criteria for selection of target companies * What inspectors are looking for * How to prepare your company for the upcoming inspections * Learning from previous inspections with focus on Part 11 and computer validation: most frequently cited deviations * How to  more...

Medical Device Tracking Latest FDA Update and Expectations - Webinar By GlobalCompliancePanel ...gulatory expectations for device tracking * Identify new terms and criteria * Understand the statutory criteria and what changed * FDA has issued orders to manufacturers who are required to track various implantable devices * Define the additional guidance factors to be considered when determining whether a tracking order should be issued * Understand why tracking  more...

Japan - Regulatory Filing Requirements and Compliance Processes for Life Sciences - Part I and Part II - Webinar By GlobalCompli ...ical o Conducting Clinical Trials o New Product Registrations & Filings o Post-Marketing Requirements o Pricing & Reimbursement * Japan's Use of ICH Standards / Principles o GCP o GMP o CTD / e-CTD Submissions * Starting-Up and Conducting Clinical Trials o Clinical Trial Start-Up process  more...

The FDAs Working Group Reports I II - New Directions - Webinar by GlobalCompliancePanel Overview: This webinar will examine the stated intent of the Agency to get tougher across the board in its expectations for the medical industry and what it (the FDA and industry) need to do internally. Examination of two recently published reports by the FDA's CDRH (devices) have identified major areas of concerns: 1) 510(k) Working Group's Preliminary Report and Recommendations, and 2)  more...

Introduction to Operational Risk - Webinar By GlobalCompliancePanel ...ty of risk frameworks competing to dominate. Based on the new Wiley and Sons book, Essentials of Risk Management, due for publication at the end of 2010, this webinar is designed to provide a non-math introduction to an area and discipline that is changing rapidly, especially in the light of the risk management failures that have shattered so many personal and professional lives. Why you  more...

The Drug Development Path - From RD to Commercialization - Webinar By GlobalCompliancePanel An overview of the drug development process, reviewing key deliverables for each stage of the development path with a special focus on managing the development process when using external resources such as Contract Manufactures, Contract Testing Labs and Contract Research Organizations. In today's fast-paced, highly regulated and risk-aversive environment, functional groups can no longer work  more...

Full Day Virtual Seminar - Reduce Software Validation Costs and Pass the New 21 CFR Part 11 Inspections - Webinar by GlobalCompl This interactive one-day seminar details how to reduce costs associated with implementing, using, and maintaining computer systems in regulated environments. Nearly every computerized system used in laboratory, clinical, manufacturing and the quality process has to be validated. Participants will learn the latest techniques for complying with 21 CFR Part 11 that greatly reduce software  more...

Training Requirements and Practices to Assure QSR and ISO Compliance - Webinar by GlobalCompliancePanel ...ining, and establishment of a training program, including new employee training, methods of training, how to document training so that it is readily available for review (by managers, auditors or inspectors), when to evaluate training requirements, training effectiveness, and when training is not required. Why Should You Attend: On of the easiest ways to be cited for a major noncompliance  more...

21 CFR Part 11 - What you need to know to pass the new FDA audits - Webinar by GlobalCompliancePanel This webinar details the regulation and how it applies to computerized systems. Learn exactly what is needed to be compliant for all three primary areas: SOPs for the IT infrastructure, industry standards for software product features, and the 10-step risk-based validation approach. This webinar demystifies Part 11, and get you on the right track for using electronic records and signatures to  more...

FDAs Update on Medical Device Labeling Changes - Webinar by GlobalCompliancePanel ...or FDA approval only when such modifications are based on newly acquired information and evidence of a causal association between the product and a safety signal is present. The rule also provides clarification as to what the Agency considers to be new information to be incorporated into a label change. Specifically, new information "must reveal risks of a different type or greater severity or  more...

BRC Risk Analysis - Webinar by GlobalCompliancePanel ...sment is a fundamental and intuitive activity that is not new to manufacturing professionals. Bringing consciousness and tangibility to this process is the challenge often faced. A practical guide documenting the process will be the topic of this training. This presentation will take you step by step through the creation of each type of risk assessment required by the BRC. Process and  more...

Revamping the 510k Clearance Process-Understanding FDAs Proposals - Webinar by GlobalCompliancePanel ...s on industry. For example, if finalized, there will be a new subclass of Class 2 products for which clinical studies will be required. You will learn of possible changes in the de novo process that could streamline the clearance process. There will be new definitions of "Substantial Equivalence" and "intended Use" will be redefined and "Indications for Use" eliminated The FDA will likely  more...

The HITECH Acts Impact on HIPPA - Webinar by GlobalCompliancePanel ...new requirements of the HITECH Act have a significant impact on the privacy and security of health information. This webinar will cover the changes required by the HITECH Act and the actions that needed to taken regarding breach notification, business associate contracts, training of staff and security of PHI for business associates. We will also discuss the best practices for data  more...

FDAs New Enforcement of 21 CFR Part 11 - Webinar by GlobalCompliancePanel ...new Part 11 regulation takes quite some time, but inspectors go out and inspect computer systems and e-records for compliance with GMPs and most recent Part11 interpretations. Just from 2007 to 2010, there have been about 30 Warning Letters related to Part 11 compliance, some with disastrous consequences for inspected companies. It seems that 'enforcement discretion' as stated in the 2003  more...

Project Management for FDA-Regulated Companies - Webinar by GlobalCompliancePanel ...ntation of Project Management Planning and Techniques for new product development, regulatory compliance audit responses, proof of "progress against plan", and ot Three of the most common tools will be discussed. One very simple approach using common Excel- or Word-type PC applications programs that can be used immediately. Regular use of a few simple but powerful tools will virtually  more...

Managing the IDE Investigational Device Exemption Submission for Compliance Success - Webinar by GlobalCompliancePanel ... includes clinical evaluation of certain modifications or new intended uses of legally marketed devices. All clinical evaluations of investigational devices, unless exempt, must have an approved IDE before the study is initiated. An approved IDE permits a device to be shipped lawfully for the purpose of conducting investigations of the device without complying with other requirements of the  more...

Outsourced processes and ISO 90012008 - Webinar by GlobalCompliancePanel ...new edition of ISO 9001 went into effect. The literature says the new version doesn't introduce any new requirements but only clarifications to the existing requirements. One of the clarifications involves the use of Outsourced Processes in the Quality Management System. The changes clarify the organization's responsibility for conformity to all customer, regulatory, and statutory  more...

Linkedin for online profile development Over 75 million professionals use LinkedIn to exchange information, ideas and opportunities * Stay informed about your contacts and industry * Find the people & knowledge you need to achieve your goals * Control your professional identity online Find past and present colleagues and classmates quickly. Discover inside connections when youa ™re looking for a job or new  more...

Key Modules of an Effective CAPA SOP - Webinar by GlobalCompliancePanel This webinar will examine the stated intent of the Agency to get tougher across the board in its expectations for the medical industry and its compliance to the cGMPs, especially CAPA. It will examine how these goals of the Agency have translated into action in the past half year, with trends evident in 483 observations and Warning Letters. A key to effective relations with the FDA is the emphasis  more...

Conduct Your Own Risk Assessments Following ISO Standard 3100031010 It is essential for any organization to first determine its risk appetite and then to conduct its own self assessment as to its actual risk exposure. The new ISO risk standards provide a straight forward method that is suitable for larger and smaller organizations alike. Aligning your risk appetite with your actual risk exposure can help rationalize and prioritize key business opportunity  more...

Advancements in Simulation Series Webinar 4 Analysis Optimization Webinar 4: Analysis Optimization Register for this series of complimentary webinars to learn about advancements in software driven product design testing. Engineers will gain insight into how to use the latest FEA software innovations to help meet business objectives such as reducing material costs, time to market and field failures. NEi Software FEA experts will provide specific  more...

Advancements in Simulation Series Webinar 3 Nonlinear Analysis Webinar 3: Nonlinear Analysis Register for this series of complimentary webinars to learn about advancements in software driven product design testing. Engineers will gain insight into how to use the latest FEA software innovations to help meet business objectives such as reducing material costs, time to market and field failures. NEi Software FEA experts will provide specific  more...

ITIL Foundation Bridge Virtual Classroom ...rvices to deliver to business expectations as part of the new v3 release of ITIL. This Bridging Course is designed as an update for candidates who hold Foundation certificates from earlier versions of ITIL to a level of knowledge and understanding in line with the ITIL v3 Foundation Certificate in IT Service Management. This course positions the student to successfully complete the associated  more...

Ten-Step Process for COTS Computer System Validation - Reduce Time and Cost ...new webinar on the topic of Ten-Step Process for COTS Computer System Validation - Reduce Time and Cost. Webinar will be on April 6, 2010. Webinar will be presented by David Nettleton. This webinar details all of the templates used to create validation documentation, usually saving two-thirds of the time and costs. The 10-step risk-based approach to COTS software validation minimized  more...

Applying Lean IT Principles to your IT department to identify opportunities to reduce waste and increase efficiency ...new webinar for the medical devices industry professionals. Webinar will be on March 30, 2010. Webinar will be presented by Bernice Russell Bond. Bernice brings over fifteen years of business operations, risk management, audit and compliance experience. She has worked for business, legal, audit, and IT management groups within various industries including manufacturing, financial and  more...

Risk-Based Validation of cGMP Systems How much validation is enough? How much is too much? When should you validate what system? Risk-based validation is the new and FDA-preferred methodology, assuring that sufficient validation is done to meet regulatory and business requirements.  more...

ISO 13485 2003 - A Straightforward Interpretation with Recommendations for Easy Implementation ...new webinar for the medical devices industry professionals. Webinar will be on March 25, 2010. Webinar will be presented by Jeff Kasoff. Development, implementation, and maintenance of an ISO 13485-compliant quality management system requires many resources and personnel to meet with success. ISO 13485 is a wordy standard, drafted by individuals for many of whom English is not their  more...

The FDA Electronic Submission Gateway ESG ...new webinar for the medical devices industry professionals. Webinar will be on March 25, 2010. Webinar will be presented by Albert Cefalo. Mr. Cefalo has a BS degree from Franklin Pierce College and a Graduate certificate in RA from Northeastern University. For the last 21 years he has been employed by Analogic Corporation. Chuck also conducts in-house training on a variety of subjects. Chuck  more...

21 CFR Part 11 - Compliance for Electronic Records and Signatures ...new webinar for the medical devices industry professionals. Webinar will be on March 24, 2010. Webinar will be presented by David Nettleton. Mr. Nettleton is an FDA Compliance Specialist for 21 CFR Part 11, HIPAA, and Computer System Validation. His latest book is "Risk Based Software Validation - Ten easy Steps" that relates to the development, purchase, installation, operation and  more...

Risk Management in IEC 60601-1 Third Edition ...new webinar for the medical devices industry professionals. Webinar will be on March 23, 2010. Webinar will be presented by Edwin L Bills. IEC 60601-1 Third Edition was released in late 2005. It is a new philosophy in standards for medical electrical devices to accommodate rapid advances in technology. This new philosophy has been difficult for test houses and compliance bodies to absorb  more...

Specification Development ...new webinar on the topic of Specification Development. Webinar will be on March 23, 2010. Webinar will be presented by Melinda Allen. A good specification not only defines the product and process being purchased by the customer, but also serves as an extension of the purchasing contract. Specifications are a customers greatest tool for ensuring products received meet the quality and safety  more...

Design Planning and conducting Effective audits ...new webinar on the topic of Design, Planning and conducting Effective audits. Webinar will be on March 23, 2010. Webinar will be presented by Mark Roberts. Internal quality system audits should be viewed as an improvement tool. Too often due they have a negative connotation and are viewed as a necessary evil. Effective audits can comply with the regulations and also be a source of  more...

21 CFR Part 11 Auditing for Part 11 Compliance GlobalCompliancePanel brings a new webinar for the medical devices industry professionals. Webinar will be on March 18, 2010. Webinar will be presented by Jasmin NUHIC. 21 CFR Part 11 is FDA regulation for electronic signatures and electronic records. It started by the pharma - it is a good regulation for medical and pharma companies but it is also a good guideline for other industries.  more...

Process Validation for Drugs and Biologics ...new webinar on the topic of Process Validation for Drugs and Biologics. Webinar will be on March 17, 2010. Webinar will be presented by James Harris. Mr. Harris has over 25 years of senior level pharmaceutical industry experience. Following this and for the past 15 years, he operated a global consulting firm that provided guidance to firms in over 60 countries around the world. During his  more...

Application Controls throughout the Life Cycle of Application Systems ...new webinar on the topic of Application Controls throughout the Life Cycle of Application Systems. Webinar will be on March 16, 2010. Webinar will be presented by Bernice Russell Bond. Miss. Bond is the President of BRUSSELL Consulting, Inc (BCI), Bernice brings over fifteen years of business operations, risk management, audit and compliance experience. She has worked for business, legal,  more...

Internal 21CFR Part 11 Compliance Auditing of Computer Systems ...new webinar on the topic of Internal 21CFR Part 11 Compliance Auditing of Computer Systems. Webinar will be on March 11, 2010. Webinar will be presented by Richard Poser. Mr. Poser is President of First Quality Inc., a quality consulting firm focused on Quality Systems, Training and Validation. Their clients include biotechnology, pharmaceutical and medical device manufacturers, as well as  more...

Quality Systems Inspection Technique QSIT and How to use it to Your Advantage ...new webinar on the topic of Quality Systems Inspection Technique (QSIT), and How to use it to Your Advantage Webinar will be on March 11, 2010. Webinar will be presented by Jeff Kasoff. Mr. Kasoff is the Director of Regulatory Affairs at Life-Tech, Inc., a leading manufacturer of consumables and instrumentation in the urodynamic and pain management fields. Jeff is responsible for oversight  more...

New Requirements for the Medical Device Directive MDD ...new webinar on the topic of New Requirements for the Medical Device Directive (MDD) Webinar will be on March 11, 2010. Webinar will be presented by Albert Cefalo. Mr. Cefalo has a BS degree from Franklin Pierce College and a Graduate certificate in RA from Northeastern University. For the last 21 years he has been employed by Analogic Corporation. During his career at Analogic he has involved  more...

Curtailing Microbial Excursions and Investigations in Pharmaceutical Water Systems ...new webinar on the topic of Curtailing Microbial Excursions and Investigations in Pharmaceutical Water Systems. Webinar will be on March 11, 2010. Webinar will be presented by Teri C. Soli. Mr. Soli has 25 years of diverse "Big Pharma" operating company experience. During his 30 year career he has lectured extensively at conferences, authored numerous papers and recently written several book  more...

Excel Spreadsheet Validation To Eliminate 483s ...new webinar on the topic of Excel Spreadsheet Validation To Eliminate 483s. Webinar will be on March 10, 2010. Webinar will be presented by David Nettleton. Mr. Nettleton is an FDA Compliance Specialist for 21 CFR Part 11, HIPAA, and Computer System Validation. His latest book is "Risk Based Software Validation - Ten easy Steps" that relates to the development, purchase, installation,  more...

Foreign Material Control GlobalCompliancePanel brings a new webinar on the topic of Foreign Material Control. Webinar will be on March 9, 2010. Webinar will be presented by Melinda Allen. Ms. Allen is a Food Safety and Quality Consultant in the Food Industry. Melinda has had a long and dedicated career of Quality Assurance and Food Safety leadership with companies such as YUM Brands and Quiznos.  more...

Validating Radiation Sterilization for medical device industries ...new webinar on the topic of Validating Radiation Sterilization for medical device industries. Webinar will be on March 9, 2010. Webinar will be presented by Mark Roberts. Mr. Roberts is the head of Roberts Consulting and Engineering (RCE), a consulting firm specializing in quality system and sterility assurance compliance. He was previously the Manager for the Western US for T V S D Product  more...

21 CFR Part 11 How to Successfully Prepare for and Host an FDA Inspection ...new webinar on the topic of 21 CFR Part 11: How to Successfully Prepare for and Host an FDA Inspection. Webinar will be on March 4, 2010. Webinar will be presented by Jasmin NUHIC. Mr. NUHIC serves a major medical devices OEM as a Sr. Compliance Quality Engineer and 21 CFR Part 11 Subject Matter Expert. He also served ASQ section as a chair for two consecutive terms, has taught quality  more...

The 510k Submission Requirements Contents and Option ...new webinar on the topic of The 510(k) Submission: Requirements, Contents, and Option. Webinar will be on March 4, 2010. Webinar will be presented by Jeff Kasoff. Mr. Kasoff is the Director of Regulatory Affairs at Life-Tech, Inc., a leading manufacturer of consumables and instrumentation in the urodynamic and pain management fields. Jeff is responsible for oversight of corporate compliance  more...

FDA Compliant HPLC Qualification and Performance Testing ...new webinar on the topic of FDA Compliant HPLC Qualification and Performance Testing. Webinar will be on March 4, 2010. Webinar will be presented by Dr. Ludwig Huber. Mr. Huber is Director of Lab compliance and Chief Advisor for global FDA compliance at Agilent Technologies. He is the editor of Lab compliance, the global on-line resource for validation and compliance issues for laboratories.  more...

Setting Up and Running a Tougher Supplier Audit Program GlobalCompliancePanel brings a new webinar on the topic of Setting Up and Running a Tougher Supplier Audit Program. Webinar will be on March 2, 2010. Webinar will be presented by John E Lincoln. Mr. Lincoln is a medical device and regulatory affairs consultant. He has helped companies to implement or modify their GMP systems and procedures, product risk management, U. S. FDA responses.  more...

FDA Inspections What to Expect and How to Prepare ...new webinar on the topic of FDA Inspections: What to Expect and How to Prepare Webinar will be on March 3, 2010. Webinar will be presented by James Harris . Mr. Harris has over 25 years of senior level pharmaceutical industry experience. Following this and for the past 15 years, he operated a global consulting firm that provided guidance to firms in over 60 countries around the world. During  more...

Business, Project and Compliance Risk GlobalCompliancePanel brings a new webinar on the topic of Business, Project and Compliance Risk. Webinar will be on March 2, 2010. Webinar will be presented by Edwin L Bills. Mr. Bills has held a number of quality and regulatory affairs positions. Mr. Bills is ASQ Certified as Quality Engineer, Quality Auditor, and as Manager of Quality/ Organizational Improvement.  more...

Multifamily Building Modeling for Weatherization Get on the fast track for multifamily weatherization work with an introduction to energy modeling for multifamily buildings. This 2-hour interactive webinar will include the basics of multifamily energy modeling using DOE weatherization approved audit tools. It will include a systematic approach to improvement-driven modeling in multifamily buildings - with plenty of opportunity to get all your  more...

Student Shelter In Computers EC-Council Academic Partner Offers Certified Ethical Hacker CEH Course Student Shelter In Computers , EC-Council Academic Partner EC-Council Academic Partner Lahore Pakistan Offera ™s Low Cost Certification & Coaching / Training for Students & Professionals Certified Ethical Hacker CEH Course Outline Module 01: Introduction to Ethical Hacking Module 02: Footprinting and Reconnaissance Module 03: Scanning Networks Module 04:  more...

Oracle Financial R12 Oracle Supply Chain R12 SOA 11g Training ...Chain R12 / SOA 11g Training We are glad to announce our New Batch on Oracle Financial R12 / Oracle Supply Chain R12 / SOA 11g In-House & Online (Virtual Class Room) Training program on March 12, 13 2011, Learn from Oracle Partners Oracle Financial R12 Training : Demo on March 12 at 10: 30 AM PST SOA Suite 11g : Demo on March 12 at 09: 00 AM PST  more...

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Basic or Core Java Long Term ...eption * File Input and Output o Create a new file and write to it o Determining properties of a file or directory o Search a text file using RegEx search with Pattern and Matcher * Serialization - Persisting data outside the JVM o Using built in Serialization techniques o Defining custom serialization o Deserializing a  more...

Oracle Financials R12 Training Oracle Financial R12 In-House & Online (Virtual Class Room) Training We are commencing New Batch on Oracle Financial R12 In-House & Online (Virtual Class Room) Training program on 11th April 2010, Learn from Oracle Partners Join our Free Demo (Class Room & Online Training)  more...

Office Organizing - Solutions Systems - On-Demand Webinar ...new or experienced Professional Organizers with a higher income stream than residential organizing can. However, if you are going to be an office organizer, you need to know how to do it well, or your reputation and your clients' businesses may suffer. Join Certified Professional Organizer ® Debra Milne as she talks about about the latest trends, resources and organizing strategies to  more...

Business Broker Training Webinar ...new business broker training program where Scott Radin spends two days with you - and you only - in an online classroom setting. He can cater the training to your background, experience level and geographic area. This is like having your own personal online business broker trainer. The training can be done during the day or in the evening. THE BEST PART - after deposit - you can break your  more...

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