I Have Web-based Seminars

Health Information Technology Introduction HCMI Workshops and courses are designed for individuals who are interested in pursuing a career in Health Information Technology. Physicians, medical records directors, and clinicians, who are evaluating or implementing electronic health records, electronic prescribing systems, and other health information technology systems will also benefit from our sessions to obtain basic knowledge to move  more...

Health Information Technology Systems HCMI Workshops and courses are designed for individuals who are interested in pursuing a career in Health Information Technology. Physicians, medical records directors, and clinicians, who are evaluating or implementing electronic health records, electronic prescribing systems, and other health information technology systems will also benefit from our sessions to obtain basic knowledge to move  more...

Inspired Goals Webinar 2011 INSPIRED GOALS | Thursday, January 12, 2012 | 2: 00 PM a 5: 00 PM CST Led by Alicia Marie Just another year? Join us for an enlightening look at how to set goals that inspire, motivate and support your vision. Give yourself the time and space you need to create your goals this year. You have never done a course quite like this one. People who participate report breakthrough results all  more...

Coaching Skills for Managers Webinar COACHING SKILLS FOR MANAGERS | Thursday, April 12, 2012 | 1: 00 PM a 4: 00 PM CST Led by Deborah Huyer Maybe you do not have to know it all or do it all? Join us for a lively discussion about coaching versus managing. Learn how to grow and develop your employees and reap the benefits of leading versus managing. (Master Communicator is a prerequisite for this course.) Register Here:  more...

Master Communicator Webinar MASTER COMMUNICATOR | Thursday, March 22, 2012 | 1: 00 PM a 4: 00 PM CST Led by Alicia Marie We learn how to communicate because we want somethinga to be held, fed, etc. Most of us still communicate for that reason and only that reason, which leads to a control/ command style of communication. As most leaders have figured out, a telling and directinga simply doesna ™t work well.  more...

Introduction to Statistics Using Common Software Packages This course measurably increases your ability to interpret, conduct, & write comprehensive marketing reports using statistics while training using Popular Statistics software. The primary goal of the course is to be able to determine which analysis is appropriate given the question and type of data given. The course will focus on pragmatic business applications, interpretations, presentation, and  more...

SAP ABAP Web Dynpro Training ERPtips SAP ABAP Web Dynpro class covers the SAP User Interface technology based on the ABAP Web Dynpro Framework. This includes the positioning of ABAP Web Dynpro in regards to other SAP UI Technologies, development of complex ABAP Web Dynpro Applications, programming techniques and specialized topics for developing robust solutions. Students will learn the components of the ABAP Web Dynpro  more...

PMP Guidance Session Live online Guidance Session for PMP Aspirants, who are interested in appearing for PMP Examination. Those who have doubts in their mind about the examination, PMI membership, eligibility, cost, training period etc. can ask questions directly & get the answers immediately by attending the session. This is a free session to educate the people about PMP (Project Management  more...

Green Business Planning - Online Workshops Create Your Own Green Sustainable Business Plan (An Online Workshop) Join Vic Desotelle from DiscoveryFuel. com for an online business planning series. http://discoveryfuel. com/ green-business-planning-workshops These workshops are for small business entrepreneurs who have dreamed of owning a sustainable business. Learn how to make a viable business plan that moves your green idea from  more...

Spiritual Practice Path Bob Dylan has a song lyric that says 'You gonna have to serve somebody'; as in practice some form of spiritual worship. That may or may not be true, but it's definitely true that anyone interested in personal growth and development has to take the chance now and then to stop and examine their beliefs and practices. We're not going to discard anything here, over 4 weeks (with a 2 month check in)  more...

MS Project 2007 and 2010 Training in Kolkata Features of the MS Project Training by Simplilearn: a Two days Comprehensive class room training by Eminent trainer a Microsoft developed Audio-video course content and offline reference material a Access to e-learning content for 1 year a Help always just a click away! a Proven study methodology a More than 6000 PMP aspirants from across 108 countries have undergone a  more...

Listening for Tech Entrepreneurs Tech Entrepreneurs can be so steeped in their product that they don't pay attention to what is happening around them, then they wonder why they're not getting funding, a market, or customers. A major factor in this challenge is the lack of well developed listening skills. Many tech entrepreneurs have no idea how they listen, let alone if their listening habits are appropriate for the situation  more...

LABOR RELATIONS TRAINING One of the most difficult things for managers to do is to manage effectively in a represented environment. This is all the more true when your managers, who were used to managing in a non-represented environment, all of a sudden have to deal with labor relations issues for the first time. We will assist your managers in dealing effectively with the labor relations process and will provide an  more...

Top Tips To Prevent Workplace Violence in your Workplace Protect Your Workplace Today! A one-hour live workplace violence training audio conference webinar that is helpful for both private as well 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  more...

Employee Handbooks Dos and Donts Employee Handbooks are essential for employera ™s in todaya ™s litigious environment. They are the number one most important tool that an employer can have to protect itself from future liability. However, there are important mistakes that employers can make that reek havoc for employers. Learn what policies must be in your employee handbook as well as phrases and terms that you  more...

Top Tips For Managers to Prevent Harassment in your Workplace The best protection is for managers to understand what their responsibilities are and learn tips to help them prevent harassment in the workplace. This interactive, informative sexual harassment prevention training, "Top 10 Tips for Preventing Harassment in Your Workplace," will provide the tips that managers should not be without. It includes a definition of sexual harassment and discussions  more...

SOA BPEL Online Training Online training in Oracle SOA BPEL SOA is the latest buzzword in the industry. The reason for its popularity is the fact that it can help bind applications easily - from SAP to Oracle Apps to Siebel to PeopleSoft to Legacy Systems to .Net systems - now you can develop applications that span all the above and more. That too, using industry standard protocols like WSDL, HTTP etc. The idea is  more...

Introduction to QuarkXPress 7 Training In this QuarkXPress training class, you ' ll use QuarkXPress to lay out professional quality single and multiple-page documents that include text and graphics, and are designed for professional printing and publication. You have probably created simple documents, such as letters and reports, using word processing applications. You most likely applied basic type formatting, included some graphics  more...

Advanced QuarkXPress 7 Training In this advanced QuarkXPress training class, you will use QuarkXPress to produce more professional-looking layouts.As you begin this QuarkXPress training class, you should already have a basic understanding of how QuarkXPress works. You may be able to create simple layouts and perform basic tasks, but find that is not enough to effectively work within a more professional, fast-paced environment.  more...

MOC 6416 - Updating your Network Infrastructure and Active Directory Technology Skills to Windows Server 2008 This Windows Server training class provides students with the knowledge and skills to work with Network Infrastructure and Active Directory technologies in Windows Server 2008. This class is intended for individuals who already have experience with Network Infrastructure and Active Directory technologies in Windows Server 2000 or Windows Server 2003 to upgrade their skills to Windows Server  more...

MOC 4995 - Programming with the Microsoft .NET Framework using Microsoft Visual Studio 2005 This .NET training class enables developers who are migrating from a different development language, an earlier version of Visual Basic .NET or Visual C#, or who have completed entry-level training and experience using Microsoft Visual Studio 2005, to gain in-depth guidance on programming the Microsoft .NET Framework versions 2.0 and 3.0 with Visual Studio 2005.This training class targets  more...

MOC 5047 - Introduction to Installing and Managing Microsoft Exchange Server 2007 SP1 In 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 recipient  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...

Administration of JBoss Application Server V4 Training This JBoss administration training class teaches the basics of the deployment and administration of web applications to a JBoss Application Server V4 environment. on Windows. This course concentrates on providing best-practice solutions to handle common problems that occur in a JBoss environment so students will have a high-level of skill with regard to JBoss administration.  more...

Web Accessibility and Section 508 Training for Experienced Web Designers In this web accessibility course, students will learn why and how to create websites that meet the Section 508 standards for website accessibility. This class targets web designers - i.e, the people who will be responsible for creating the accessible pages. Students attending his class are expected to have expert knowledge of HTML and at least intermediate knowledge of CSS. If you are  more...

Adobe After Effects CS4: Motion and Sculpting In this Adobe After Effects training course, students who already have experience with After Effects will learn to improve their motion graphics and visual effects by taking the rhythm of their movement and treatment of their graphical elements to another level.  more...

Advanced Microsoft Access 2007 Training In this Microsoft Access training course, students learn some of the more specialized and advanced capabilities of Microsoft Access by structuring existing data, writing advanced queries, working with macros, enhancing forms and reports, and maintaining a database. Students also learn to share data with other applications, automate business processes by using VBA code, and secure and share  more...

Presentations: Preparing, Developing, and Delivering This training course introduces students to the fundamentals of creating a presentation. Students will discuss the components of a good speech or presentation, and then they will learn how to develop their own. As students work through the activities, they will write and deliver three short presentations in class. They will be introduced to a variety of delivery techniques that include building  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...

SQL Server 2005 Analysis Services (SSAS) Training In this SSAS training course, you will learn how to use Microsoft SQL Server 2005 Analysis Services (SSAS) to design and implement OnLine Analytical Processing (OLAP) cubes and data mining models to support Business Intelligence (BI) solutions.This SSAS course includes concepts, procedures and practices based on real-world experience giving both the novice and experienced SQL Server 2005 developer  more...

MOC 6451 - Planning, Deploying and Managing Microsoft System Center Configuration Manager 2007 This Configuration Manager training class provides students with the knowledge and skills to plan, deploy, and manage Configuration Manager 2007. The class focuses on planning and deploying sites and clients, configuring software distribution, deploying operating systems, and managing software updates. It also focuses on remote tools and managing mobile devices.This training class is intended for  more...

MOC 6438 - Implementing and Administering Windows SharePoint Services 3.0 in Windows Server 2008 This SharePoint training class provides the knowledge and skills that IT Professionals need to configure Microsoft Windows SharePoint Services in Windows Server 2008.This class is meant for Windows SharePoint Server 3.0 administrators, who are responsible for planning, deploying and managing Windows SharePoint Services 3.0 servers and sites in a Windows Server 2008 environment. Students taking  more...

MOC 5115 - Installing and Configuring the Windows Vista Operating System This Windows Vista training class provides students with the knowledge and skills to install and configure Windows Vista desktops.It focuses on four main areas: installing, securing, networking, and browsing. By the end of the class, the student will have installed and configured a Windows Vista desktop that is secure, on the network, and ready for browsing.This is the first course in the Windows  more...

MOC 2310 - Developing Microsoft ASP.NET Web Applications Using Visual Studio 2008 This ASP.NET training class will teach Microsoft Visual Basic programmers and beginning Web developers the fundamentals of Web application site implementation by using Microsoft ASP.NET and Microsoft Visual Basic .NET. This class focuses on using the Microsoft Visual Studio .NET environment and the Microsoft .NET platform to create an ASP.NET Web application that delivers dynamic content to a Web  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...

Better Methods To Control Tools Fixtures in Production Manufacturing ANYTHING requires tools, fixtures and supplies; in addition to people, machines, materials and methods. And while most improvement initiatives focus on production methods and material availability, it is often the tools and fixtures that cause manufacturing disruptions, sometimes leading to shipping delays and customer dissatisfaction. How many times have you been ready to produce,  more...

How to Dramatically Improve the Quality of Your Shipment ForecastsTechniques to Improve Forecast Inputs Supply-chain professionals must NEVER stop thinking about the integrity of the shipment forecast. This is because a shipment forecast represents independent demand for company product which in turn drives the Master Production Schedule (MPS) process. Start with an inaccurate shipment forecast and a poor performing MPS is sure to follow. Continue with a poor forecasting process and inventory will  more...

How to Factually Evaluate Critical Supplier Performance and Risks Manufacturers and distributors are choosing to source significant amounts of materials and components from global suppliers and are creating substantial risks within their supply chains. Companies are discovering that sourced-material disruptions can and often do, result in dramatic and unfavorable impacts to material delivery reliability, total material cost and received material quality.  more...

How to Conduct an Effective Monthly Variance Review Meeting It has been said that difference between a GOOD plant manager and a GREAT plant manager is often in how operating variances are routinely addressed and how corrective actions are routinely executed. Great plant managers always conduct a routine a Variance Review Meetinga each month, challenging their direct reports to explain all significant variances from plan. These variances are usually,  more...

How to Achieve Maintain ERP Systems Master File Data Integrity You are invited to attend the Manufacturing Executive Institutea ™s May 19th 2011 3rd Thursday - a Operations Improvement Series FREE webinar, How to Achieve & Maintain ERP Systems Master File Data Integrity. Contrary to the popular belief that modern, fully-integrated information systems provide executives with the tools to make more effective and efficient decisions, there is increasing  more...

Preserving Precious Capital Attacking the SEVEN Most Significant Capital Wasters in Your Company Times are tough and capital preservation is at the top of every executivea ™s priority list. But specific techniques necessary to rapidly eliminate waste and reduce operating costs can be difficult to define and even more difficult to implement. If you manage ANY type of an organization, you have waste which steals precious capital from your enterprise. Now, more than ever, it is important  more...

A Case for Routine Use of Statistical Process Control SPC in Manufacturing You are invited to attend the Manufacturing Executive Institutea ™s FREE February 2011 3rd Thursday - a Operations Improvement webinar, A Case for Routine Use of Statistical Process Control (SPC) in Manufacturing. Statistical Process Control is a term that describes a process for predicting failures and methodically determining the underlying cause(s) before the predicted failures can  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...

New Final HIPAA Amendments New final rules for HIPAA Expand the Scope and Increase Responsibilities This Webinar will help health information professionals understand what they have to do, and when, and what to keep in mind as they move 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  more...

FDAs 21 CFR 11 Add-On Inspections - Recent Updates - Webinar By GlobalCompliancePanel This presentation will cover the scope, status and results of the surveillance inspections and what they may mean for the future of 21 CFR Part 11. This will enable you to determine whether your company is subject to the most common violations so you can take action to have a better inspection outcome. Tuesday, February 14, 2012 10: 00 AM PST | 01: 00 PM EST  more...

Portfolio Optimization for Global Drug Development - Webinar By GlobalCompliancePanel Strategic portfolio planning is crucial for developing long-term company strategy. The goal is to meet strategic objectives selecting the "best" portfolio of internal and external drug development programs for funding and balance company resources including money, manpower and manufacturing capacity. Projects could be interdependent, have multiple development scenarios, and are subject to multiple  more...

Risk Management in IEC 60601-1 Third Edition - Webinar By GlobalCompliancePanel 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 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...

Risk Management in the Pharmaceutical Supply Chain - Webinar By GlobalCompliancePanel Supply chains for pharmaceutical products have become increasing complex as the industry has outsourced many non-core activities to third party contractors and sought lower prices for their materials around the global. Tuesday, December 13, 2011 10: 00 AM PST | 01: 00 PM EST  more...

Hazard Analysis A practical guide - Webinar GlobalCompliancePanel Hazard analysis meetings, you have probably spent hours discussing whether a scenario is a hazard, or the cause of a hazard, or debating whether the probability of an unmitigated hazard is high or low, or went off on a tangent evaluating very unlikely hazard scenarios, or wrestled with group members who consider hazard analysis meetings a waste of time. Tuesday, December 6, 2011 10: 00 AM  more...

Equipment Validation Tracking Calibration and Preventive Maintenance - Webinar GlobalCompliancePanel FDA and EU regulations require that firms have a program for the calibration and maintenance of test and measurement equipment. Wednesday, December 14, 2011 10: 00 AM PST | 01: 00 PM EST  more...

Best Practices in Key Financial Metrics - Webinar By mentorhealth Hospital executives have a hard job to do! In attempting to create and achieve an effective strategic plan, there is a great need to determine specific outcomes that will be consistent with the organization's underlying mission, broad policies, culture and accepted industry normsa .But what exactly does this mean? What are the elements that will be instantly recognizable as "a" or "the" key  more...

Important Sterilization Information for Product Developers - Webinars GlobalCompliancePanel Product developers have the responsibility of the development of medical devices or healthcare products that will be sterilized; however they may not have an adequate understanding of the sterilization processes and its impact to the functionality of the product and its package. Tuesday, November 29, 2011 10: 00 AM PST | 01: 00 PM EST  more...

Designing and Conducting Effective Structured Interviews - Webinar By TrainHR This webinar will cover the process of determining the right questions to predict success on the job, including questions to determine a cultural match to the organization, how to design a program with the advantages of structured interviews and elimination of the disadvantages some programs have  more...

Performance Management The Key to the Castle - Webinar By TrainHR This webinar has been carefully designed to ensure an optimum learning experience. We have drawn upon the expertise of many of the best minds in the industry in creating a program that will not only inform, but teach practical skills, as well.  more...

Human Capital Organizational Structure and Human Resources - Webinar By TrainHR This webinar has been carefully designed to ensure an optimum learning experience. We have drawn upon the expertise of many of the best minds in the industry in creating a program that will not only inform, but teach practical skills, as well.  more...

Contingency Plan for Disasters - Are You Prepared - Webinar By GlobalCompliancePanel Most medical and dental practices are ill prepared for disasters. In addition to the enormous difficulty in returning to business following a disaster, OSHA and HIPAA rules now require that medical and dental practices have a plan of action that will ensure that patient data will not be lost and to also have a plan in place to provide a return to care for its patients. Tuesday, November 8, 2011  more...

Dental - Medical Cross Coding - Webinar By GlobalCompliancePanel Medical Coding in dental practices is gradually becoming a necessity. Many dental practices have long been sheltered from having to explain to dental carriers why they performed the patients' procedures. They have simply submitted codes for the procedures that were performed. Wednesday, October 12, 2011 10: 00 AM PDT | 01: 00 PM EDT  more...

Hazard Analysis A practical guide - Webinar By GlobalCompliancePanel If you have participated in hazard analysis meetings, you have probably spent hours discussing whether a scenario is a hazard, or the cause of a hazard, or debating whether the probability of an unmitigated hazard is high or low, or went off on a tangent evaluating very unlikely hazard scenarios, or wrestled with group members who consider hazard analysis meetings a waste of time. Thursday,  more...

Equipment Validation Tracking Calibration and Preventive Maintenance - Webinar By GlobalCompliancePanel FDA and EU regulations require that firms have a program for the calibration and maintenance of test and measurement equipment. Thursday, October 20, 2011 10: 00 AM PDT | 01: 00 PM EDT  more...

Meeting Annual US FDA cGMP Training Requirements - Webinar By GlobalCompliancePanel There is an on-going major shift in the emphasis of U. S. FDA CGMP compliance audits. These changes in focus have a major impact on individual compliance objectives, efforts and measurements of success. Wednesday, October 5, 2011 10: 00 AM PDT | 01: 00 PM EDT  more...

Introduction to Contamination Control Master Plans - By GlobalCompliancePanel Why you should attend: Manufacturers of human medical products have established myriad control programs to comply with FDA regulations regarding control of product contaminants. However, due to variable emphasis being placed on each of these control elements by FDA auditors, most manufacturers have developed their programs in a piecemeal fashion. Thus, each element in a manufacturer's control  more...

JAVA J2EE JEE Professional Role Based Training from Zaran Tech TRAINING DETAILS: Course Duration: 80 hours Training + Actual project Case Studies + Assignments Training Materials: All attendees would receive a Assignment after each module, a Notes and study material for examples covered. Training Format: This course is delivered as a highly interactive session, with extensive live examples. This course is delivered in Online using Web and Audio  more...

Designing Drafting Writing and Implementing The Quality Manual his webinar will begin with a brief discussion about quality then begin to explore how quality manuals have evolved into a communications device that assists all functions to reach their goals and objectives. It will demonstrate that the quality manual represents system for working together to achieve the organization's goals. You'll be shown that a quality system exceeds compliance  more...

A Simpler Approach to Implementing or Validating CGMPs to 21 CFR 11 Electronic Records Signatures - Webinar By GlobalComplianceP The verification and validation of electronic records and electronic signature software is coming under increased scrutiny by the U. S. FDA. This webinar will address the use of FDA Guidance's, GAMP, 21 CFR Part 11, "Electronic Records" / "Electronic Signatures", and other applicable industry software validation models, coupled with the ISO 14971 / ICH Q9 Product Risk Management models, to  more...

Design Planning and Conducting Effective Audits - Webinars by gcp 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 improvement.  more...

FDA Inspections - Dos Donts The purpose of the FDA inspection is a verification activity that should demonstrate to the regulatory agency and provide assurance that products consistently meet quality expectations and that your company is operating in a consistent and compliant state of control.  more...

Design Planning and Conducting Effective Audits by gcp 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 improvement.  more...

Preventing Food Safety Problems BY GCP Most industries have become reasonably sophisticated in terms of applying the principals and tools involved in quality control and improvement.  more...

ISO 13485 for Medical Device QMS by GCP This webinar will provide valuable assistance to all device manufacturers who wish to have a better understanding of the requirements of ISO 13485.  more...

Breakthrough Performance Management that is Practical Effective and User-Friendly Overview : The performance conversations method is designed to provide feedback, not appraisal. This approach provides real time information that the employee can use to make adjustments to their work so that fewer corrections are necessary. The three ingredients to successful outcomes are feedback, accountability, and growth. Using this method, the manager becomes a coach who spurs on the  more...

The Law and Psychology of Mental Health Issues at Work Substance Abuse Depression and the Bermuda Triangle of the ADA the FMLA a This workshop helps HR professionals understand how to navigate the difficult and often murky challenge of dealing with "invisible disabilities." To make matters more confusion, the recent amendments to the A. D. A. have a significant impact on the rights of mentally employees as well as the responsibilities of employers. This practical workshop address both the legal and psychological issues  more...

Document Retention and Destruction You should attend this webinar to be sure both you and your staff in charge of records understands the responsibility and importance of knowing and following proper procedures. When auditing how information is kept by Human Resource Departments, many questions come up regarding where records are kept, how long they should be kept and when and how they should be destroyed in order to stay in  more...

Coaching and Mentoring for High Performance by TrainHR Coaching and mentoring are critical skills that every manager should be engaged in order to develop the competence and confidence of employees. Great organizations achieve their full potential because they have exceptional people. But few people are born great. Nor are most people exceptional the day they begin work. They become high performers after they have been trained and given the  more...

Preventing Harassment in the Workplace by TrainHR This webinar will concentrate on what is considered sexual harassment as well as covering other types of harassment in the workplace. It will review the laws protecting employees from harassment and the recourses employees have. It will define who is covered and describe the two main kinds of sexual harassment in the workplace. It will cover what should be in an effective Harassment policy, how  more...

Auditing and Administrating Human Resources Policies and Practices by TrainHR This webinar will concentrate on making sure you have current human resources policies that are in compliance with applicable laws and convey the desired practices in your organization. Policy should be reviewed and updated periodically and through this webinar you can review your current policies, clarify policies for easier administration, and perhaps add new policies others to address new  more...

How to Conduct an Offensive Behavior Investigation by TrainHR This program will help you understand how to conduct discrimination and harassment investigations. Learn how to avoid the legal pitfalls of conducting discrimination investigations. Learn how flawed investigations can cause nightmares for employers. Understand when you need to call in a professional to conduct your investigation. Receive updates on the most recent cases on these issues and  more...

Relationship Selling Building Relationships through 1 to 1 Sales by TrainHR Relationship Selling: Building Relationships through 1 to 1 Sales will provide you with tips, tools and solutions you can use now to get customers, keep the ones you have and get enthusiastic referrals. We will specifically work on the foundation of all sales - Building Relationships 1 by 1.  more...

The Law and Psychology of Mental Health Issues at Work Substance Abuse Depression and the Bermuda Triangle of the ADA the FMLA a This workshop helps HR professionals understand how to navigate the difficult and often murky challenge of dealing with "invisible disabilities." To make matters more confusion, the recent amendments to the A. D.A. have a significant impact on the rights of mentally employees as well as the responsibilities of employers. This practical workshop address both the legal and psychological issues  more...

The Law and Psychology of Mental Health Issues at Work Substance Abuse Depression and the Bermuda Triangle of the ADA the FMLA a This workshop helps HR professionals understand how to navigate the difficult and often murky challenge of dealing with "invisible disabilities." To make matters more confusion, the recent amendments to the A. D.A. have a significant impact on the rights of mentally employees as well as the responsibilities of employers. This practical workshop address both the legal and psychological issues  more...

Document Retention and Destruction by TrainHR You should attend this webinar to be sure both you and your staff in charge of records understands the responsibility and importance of knowing and following proper procedures. When auditing how information is kept by Human Resource Departments, many questions come up regarding where records are kept, how long they should be kept and when and how they should be destroyed in order to stay in  more...

Adverse Event Reporting for Dietary Supplements and OTC Drugs - Webinar By GlobalCompliancePanel Since passage of the Dietary Supplement & Nonprescription Drug Consumer Protection Act in Dec. 2007, FDA requires reporting of serious adverse events for dietary supplements and OTC drugs. Manufacturers and importers of products in these categories often have questions about what constitutes a serious adverse event and about Adverse Event reporting requirements that this Webinar will be able to  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...

HIPAA Enforcement and Compliance Audits What the auditors want and how to be ready before they call - Webinar By GlobalComplianc Overview: 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 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  more...

Instructor-Led Live Online Video Training - leadership classes Instructor-Led Live Online Video Training a Near Classroom Superior Experience Instructor-Led Live Online Video leadership classes How Does the OnLine Program Work? The Instructor-Led Live Online Video leadership classes are conducted in real time, by a live instructor in a remote location and a number of employees in their own worksite. The employees may be located in their companya  more...

HIPAA Security Policies and Procedures Making them useful and relevant as well as compliant - Webinar By GlobalCompliancePanel Overview: If you handle any electronic patient information, dona ™t miss this teleconference on compliance with the extensive requirements for policies and procedures in the HIPAA security regulation. Electronic patient information is everywhere; not only is electronic protected health information in the obvious places such as practice management systems and electronic medical records, but  more...

Information Security and Payment Card Rules Protecting Patient Payment Data and Complying with PCI - Webinar By GlobalCompliance ...n compliance with multiple regulations * HIPAA and PCI have many similarities, but some important differences as well. Keeping your information well controlled can help with both. * Find out about how you can discover where payment card information is and is not needed, and how to keep it to a minimum so you can limit your exposure to the PCI requirements * Do you know what to do  more...

The GCPICH Obligations of Sponsors Monitors and Investigators - barriers and solution - Webinar By GlobalCompliancePanel Overview: 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. 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  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...

Develop and Execute the Company Software VV Program - Webinar By GlobalCompliancePanel Overview: The verification and validation of medical software is coming under increased scrutiny by the U. S. FDA. This webinar will address the use of the FDA, GAMP, 21 CFR Part 11, "Electronic Records" / "Electronic Signatures", and other applicable industry software validation models, coupled with the ISO 14971 / ICH Q9 Product Risk Management models, to structure, run, and document  more...

Root Cause Analysis - The Heart of a Successful CAPA Program - Webinar By GlobalCompliancePanel Overview: Root Cause Analysis (RCA) is a major tool in product complaint, non-conformance, and OOS failure investigations, and hazard analysis / risk management and mitigation activities. It is required in resolving verification and validation issues including data outliers that frequently but are often improperly dismissed arbitrarily. It is required in order to "close-the-loop" on corrective  more...

Developing the Master VV Plan to Meet US FDA ISO 13485 and 14971 Requirements - Webinar By GlobalCompliancePanel Overview: FDA Warning Letters and recent high-profile recalls indicate major cGMP deficiencies in many companies. One major failing is lack of sufficient or targeted risk-based company-wide V&V planning. Starting with a Master Validation Plan, evaluating its elements against ISO 14971 hazard analysis / risk management, allows development of meaningful product validations. The roles of different  more...

Design History File DHF Device Master Record DMR Device History Record DHR and Technical File TF - Regulatory Documents Explaine Overview: This Webinar is designed for people involved in document preparation and maintenance, and those who have involvement with documentation. The FDA QSR and the Medical Device Directive specify certain documents or records that should be included in your organization's quality systems - Design History File (DHF), the Device Master Record (DMR) the Device History Record (DHR), and the  more...

Webinar on Cloud Computing SaaS - Webinar By GlobalCompliancePanel Overview: The Cloud Computing / Software as a Service (SaaS) Webinar will present the best practices for the validation of a SaaS Customer Relationship Management (CRM) Solution. Our presentation will offer an introduction to cloud computing and explain the benefits of using a SaaS system. We will detail the differences between a Conventional Implementation and a SaaS Implementation  more...

Understanding Attribute Acceptance Sampling including Z14 and c0 Plans -- Webinar By GlobalCompliancePanel Overview: This course provides the attendees with the tools needed to understand and implement acceptance sampling. We explain the basis for sampling plans, the binomial distribution, and show how it helps us understand the sampling plan's performance using the operating characteristic (OC) curve. Participants will gain a solid understanding of how the OC curve is built, how to use it, and how  more...

Requirements of the Master Production Record - Webinar By GlobalCompliancePanel Overview: This program will address the 21CFR and Eudralex Volume 4 requirements and interpretation, as well as FDA Guidance regarding the creation, review and approval, and control of Master Production Records. The material will enable attendees to establish a consistent approach to the design of MPR, including cover page content, instructions, processing requirements and limits, and signature  more...

FDA Clinical Trial Auditing and the due diligence Companies should conduct as part of their monitoring program - Webinar By GCP Overview: The main principle is to follow exactly the signed and approved (IRB + PI) Protocol to the letter. This, in fact, is included on the FDA Form 1572. In the current regulatory climate, GCP Investigator site audits are a part of the clinical trail process. Sponsors should anticipate more inspections and information requests regarding monitoring practices. Many monitoring systems lack  more...

Online Personal Financial Management Coaching NOW you can learn how to... ...pay off your debt ...make a budget ...set financial goals Learn how to manage your personal finances the easy way. Enroll for an online coaching NOW!! Email me at 1920solutions@gmail. com for more details, schedules and fees. NOW you can get Financial Management Coaching at the convenience of your home. Coaching includes the following: -  more...

Facilities Cleaning in Cleanrooms and Controlled Environments - Webinar By GlobalCompliancePanel Overview: This live webinar concentrates on proper cleanroom cleaning, and discusses tools, equipment, agents, personnel training, extent, and frequencies. It is a very practical training session intended to assist personnel involved in the design, cleaning, monitoring, and assessment of cleanroom cleaning procedures. The key benefits of this course are: * In-dept understanding of  more...

Calibration and Qualification in Analytical Laboratories - Webinar By GlobalCompliancePanel Overview: Laboratory equipment should be calibrated and/ or qualified to demonstrate suitability for the intended use. Laboratory systems including equipment are amongst key targets of FDA inspections. They are considered high risk systems because they have a high impact on product quality. Despite the fact that equipment calibration and qualification is nothing new and companies spend a lot of  more...

The Use and Mis-use of FMEA in Medical Device Risk Management - Webinar By GlobalCompliancePanel Overview: The purpose of FMEA is to affect the design and the most practical time to do this is when competing designs are being considered, not after choices have been made, contracts signed, and prototypes being built and tested. Of course, there are other reasons for performing a FMEA. FDA requires risk assessment (hazard analysis) but a FMEA conducted late in the product development process  more...

A Comparison of the Pharmaceutical and Medical Device Good Manufacturing Practices - A Study of Similarities and Differences - W Overview: As a quality professional, you desire to have the very best quality system that operates effectively, efficiently and conforms to the appropriate quality standards to meet customer and user needs. You are also aware that there is a paradigm shift from an emphasis on compliance to an emphasis on quality based systems. An understanding of this paradigm shift can be gained by comparing  more...

Navigating the Regulatory Environment for the Implementation of Alternative Microbiology Technologies - Webinar By GCPanel Overview: Rapid microbiological methods (RMMs) have been implemented by a number of companies around the world. In some cases, it is necessary to work with regulatory authorities in order to effectively introduce a RMM in place of an existing microbiology method. This is especially true if the existing method is incorporated in a previously approved regulatory dossier, such as a New Drug  more...

Validation of ExistingLegacy Computer Systems for FDAEU Compliance - Webinar By GlobalCompliancePanel Overview: When existing or legacy computer systems are used in FDA or equivalent international environments they should be validated, a process sometimes called retrospective validation. While 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  more...

HIPAA Business Associates How the regulations have changed and what you need to do for compliance now - Webinar By GCPanel Overview: HIPAA Business 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  more...

HIPAA Breach Notification What to do to prevent breaches and what to do when they happen to you - Webinar By GCPanel Overview: The 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  more...

Overall Residual Risk Evaluation - Webinar By GlobalCompliancePanel Overview: This presentation discusses practical methods of performing Overall Residual Risk Evaluation and methods for documenting the results of the evaluation activity. Overall Residual Risk Evaluation requires a cross-functional team to perform the evaluation, which will be an important part of this presentation. Why you should attend: One of the most important Risk Management activities is  more...

Documentation for IEC 60601-1 3rd Edition Compliance - Webinar By GlobalCompliancePanel Overview: In this presentation we will review the certification requirements for documentation of the clauses of IEC 60601-1 Third Edition. The purpose will be to provide medical device manufacturers with information on how to provide certification bodies with the information they need to certify products to the Third Edition in the most efficient manner. By preparing in advance for  more...

FDAs New Process Validation Guidance - Webinar By GlobalCompliancePanel Overview: Nearly two years after releasing a draft validation guidance to replace their antiquated General Principles of Process Validation (1987), in January 2011 FDA finally published the official standard. While technically"guidance," FDA has indicated they will enforce compliance rigorously. This complete overhaul of FDA's primary validation standard brings U. S. drug. API, and biologics  more...

Food Drug Cosmetic Act Implementing Regulations Major New Laws - An Overview - Webinar By GlobalCompliancePanel Overview: Food, Drug, and Cosmetic Act history basics will be covered as will implementing FDA regulations relevant to the Food, Dietary Supplement and OTC Drug 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  more...

Process Validation for Medical Devices - Webinar By GlobalCompliancePanel Overview: This course provides regulatory/ quality professionals, manufacturing engineers, and process development engineers with the knowledge and skills needed to comply with the process validation requirements of the FDA's Quality System Regulation, ISO 13485 and the GHTF Validation guidance N99-10 while offering information on how to implement an effective validation program. The purpose of  more...

How to use QSIT to Your Advantage - Webinar By GlobalCompliancePanel Overview: Virtually all field inspections performed by FDA inspectors are done according to the QSIT. It is thus imperative that all regulated companies have an in-depth knowledge of this system, to enable them to prepare for the inspection. Delving into each and every section of the QSIT, this webinar also includes straightforward, helpful methods for incorporating it into your companya  more...

Purchasing and Supplier Controls in the Medical Device Industry - Webinar By GlobalCompliancePanel Overview: Supplier qualification and assessment is required in both the QSR regulations and ISO standards. Many companies spend a great deal of time and money in pursuit of compliance with this. Many companies can spend MUCH LESS time and money, and still be in control of their suppliers and in compliance with the regulations. This presentation will review the QSR and ISO requirements for  more...

Best practices for conducting OOS investigations - Webinar By GlobalCompliancePanel Overview: This interactive webinar will review the regulatory requirements for an OOS Investigation. The responsibilities of the analyst, the supervisor and QA will be discussed. A detailed flow chart will be used to help the attendees clearly understand the steps and the order in which they are to be performed. Common pitfalls and means of overcoming them at each of the steps will be  more...

Medical Device Recalls How to Manage Them and Recent Trends - Webinar By GlobalCompliancePanel Overview: Medical devices are classified into three classes, Class I, II, and III, based on the level of control necessary to assure the safety and effectiveness of the device. Recalls of Class II devices represent 61% of all device recalls over a review period, followed by Class III devices at 28%. This Webinar will provide a recent update on the latest trends and causes for device recalls and  more...

Off-Label Promotion of Drugs - Regulatory Documents Explained - Webinar By GlobalCompliancePanel Overview: Promoting a drug or device for a use not approved by the Food and Drug Administration is illegal. As a result of this practice, called "off-label promotion," life sciences companies have been fined unprecedented amounts of money and their executives have been prosecuted criminally. In addition to the regulatory and criminal consequences of off-label promotion, companies that promote  more...

Project Management for Clinical Trials - Webinar By GlobalCompliancePanel Overview: This web seminar has been designed to provide you with a clear understanding of project management skills to apply to running clinical trials. It will ensure you gain a clear understanding of the tools and techniques of project management for clinical trial and how they can be applied to your own pharmaceutical projects in the work place. In addition to key project management tools  more...

Meet FDA Expectations for a Tougher Supplier Audit Program - Webinar By GlobalCompliancePanel Overview: There is a pervasive public perception that the 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  more...

Developing and Using the Product Risk Management FileReport - Webinar By GlobalCompliancePanel Overview: Expectations for meaningful hazard analysis, hazardous conditions, and documentation have always existed by regulatory agencies. There is an increased awareness of the importance of design activities to support the production of safe and effective product. Product risk management is a required tool to drive and direct resource constrained product design, manufacture and validation  more...

Change Control -- Your Companys GMP Weak Point - Webinar By GlobalCompliancePanel Overview: There is a pervasive public perception that the FDA 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  more...

Tougher US FDA cGMP Compliance Audits - When Youre Not Ready - Webinar by GlobalCompliancePanel Overview: There is an on-going major shift in the emphasis of U. S. FDA cGMP compliance audits. These changes in focus have a major impact on individual compliance objectives, efforts and measurements of success. The Agency has come under increasing negative publicity due to multiple drug recalls and pulling of product off the market, importation of tainted foods, lead based paint in toys, and  more...

Introduction to Investment Risk - Credit Market and Portfolio - Webinar by GlobalCompliancePanel Overview: This three hour overview of investment risk will provide the fundamentals to market, portfolio, and credit risk management that all investors, and those in financial services need to comprehend. Regardless of job titles, investment risk management is a shared responsibility by a wide range of managers. Compared to accounting, risk is an immature discipline with a variety of risk  more...

Information Security - Overview Information security means protecting information and information systems/ assets from unauthorized access, use, disclosure, disruption, modification or destruction. Every individual who deals with information should have a better understanding on how to safeguard his/ her personal or company's data. This session will assist partcipants to 1. Understand WHAT, HOW & WHY of information  more...

Excel Spreadsheets and FDA Device Regulations - Webinar by GlobalCompliancePanel Overview: This webinar helps you understand the FDA device regulations related to Excel spreadsheets. These spreadsheets can be automated processes and create electronic records. Both of these aspects are regulated by the FDA, so device manufacturers must understand the regulations and how to apply them. The seminar begins with Excel methods to help ensure the spreadsheet produces the results  more...

Introduction to Contamination Control Master Plans - Webinar by GlobalCompliancePanel Overview: This webinar concentrates on the value of creating a master plan for contamination risks within a GMP manufacturing company. It provides an introduction to the creation, implementation, and maintenance of a Contamination Control Master Plan. Key benefits of this seminar include: * Achieve satisfactory inspections more easily * Higher assurance of new medical product  more...

International Financial Reporting Standards The Basics - Webinar by GlobalCompliancePanel Overview: Where business is concerned the world is becoming a smaller place. Trade boundaries are disappearing, and many companies have subsidiaries around the world. Multi-national corporations needed a simpler way to put together their consolidated financial statements. Already Australia, most of Europe, and many other countries have adopted International Financial Reporting Standards.  more...

Effective Corrective and Preventive Actions CAPA 10 Steps to Success - GlobalCompliancePanel Virtual Seminar - Webinar By Global Overview: This CAPA training program helps you to understand, in 10 easy steps, the entire CAPA process. It includes elements of Quality Tools, Team Effectiveness, Awards & Recognitions, and Verification & Validation of actions taken. Attend this webinar to grasp the A to Z of CAPA and learn how to implement & manage it for success. Why Should You Attend: We have found out, through auditing  more...

21 CFR Part 11 Complete Manual For Compliance Success - GlobalCompliancePanel Virtual Seminar - Webinar By GlobalCompliancePanel Overview: 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. Why Should You Attend: FDA inspectors are ever increasing the number of inspections where they include Part 11 as a part of the scope or THE scope of the inspection.  more...

Utilizing Good Requirements as a Foundation for the Effective Validation of PDMA-related Computerized Systems - Webinar By Globa Overview: Computerized systems can be a boon to the Sales and Marketing group of an organization that falls within FDA regulatory authority. By automating, tracking, and reporting on thousands of sample product transactions, such systems can provide a powerful mechanism for compliance to the requirements of the Prescription Drug Marketing Act (PDMA), while accomplishing this with a manageable  more...

Controlled Substances and the Pharmacist - Webinar By GlobalCompliancePanel Overview: The public media has been reporting the abuse of narcotic drugs prescribed for pain management with its focus on the legitimacy of prescriptions and the dispensing by a pharmacist. Both federal and state regulations have placed the responsibilities on the physician who wrote the prescription and the pharmacist who filled the prescription. Today's pharmacists will need to familiarize  more...

Medical Device Changes and The 510k - Webinar By GlobalCompliancePanel Overview: This webinar will examine the broad range of issues to be considered by a company when reviewing 1) A series of minor changes or 2) One major change to an existing 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  more...

Effective Training Practices for FDA Compliance - Webinar By GlobalCompliancePanel Overview: This presentation 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  more...

Legal Risks in Social Media for Healthcare Providers - Webinar By GlobalCompliancePanel Overview: Most sophisticated businesses use social media sites such as Facebook, MySpace, Twitter, and LinkedIn to promote their services, connect with their customers, and as a overall component of their business strategy. Physicians and other healthcare providers have begun to experiment in the social media environment, but most are concerned that the special rules applicable to the  more...

Chemical Control for Food Manufacturers Ingredient Cleaning and Hazardous Materials - Webinar By GlobalCompliancePanel Overview: A comprehensive review of an ideal chemical control program will be presented. The guidelines presented will enable your company to implement programs that are cost effective and meet or exceed the expectations of major QSR, and GFSI audit criteria. This presentation will provide not only a provide schematic for management and control of chemicals, but an interactive and customizable  more...

Why is CAPA so often cited in medical device inspections - Webinar By GlobalCompliancePanel Overview: This presentation will explore FDA Corrective Action and Preventive Action findings in medical device manufacturer quality systems to determine FDA's concerns. The FDA and ISO 13485 requirements for CAPA will be reviewed to identify how procedures may define a compliant CAPA system. Implementation and maintenance of the CAPA system will be explored. FDA indicates that CAPA systems  more...

Avoiding FDA 483 Observations by Identifying the Root Cause of Deviations - Webinar By GlobalCompliancePanel Overview: Recent Consent Decrees have included requirements that the firm develop and implement systems that result in timely and complete investigations of deviations and corrective and preventive actions that address the root cause of deviations. FDA 483 and Warning letter observations identify inadequate investigations and follow-up. This webinar addresses adequate investigation of  more...

Using Foreign Trial Data in Your NDA Approval Process - Webinar By GlobalCompliancePanel Overview: In this NDA Approval Process training Webinar learn the guidance and regulations governing FDAa ™s acceptance of foreign trial data and know how FDA implementing these rule along with design considerations and requirements for foreign trials. Why you should attend: While the law allows 100 percent of pivotal data to come from foreign trials, there have been very few such  more...

Complying with HIPAA Security Rules Whats in the rules and how you can most easily prepare for compliance - Webinar By GlobalCom Overview: If you handle any electronic patient information, don't miss this teleconference on compliance with the HIPAA security regulation. Electronic patient information is everywhere; not only is electronic protected health information in the obvious places such as practice management systems and electronic medical records, but also in less obvious places such as copiers, printers, scanners,  more...

Water System Biofilm Control and Microbial Monitoring Myths - Webinar By GlobalCompliancePanel Overview: It is an unfortunate fact that most water systems today have been designed and are operated and controlled using at least some traditional concepts and methods that are downright wrong. So how could such traditions become so ingrained and be so wrong? How could well-intentioned benchmarking be so misguided? There are many reasons, which will be discussed, but regardless of the causes,  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...

Medical Device Reporting Regulations and Violations - Webinar By GlobalCompliancePanel Overview: This presentation will review the Medical Device Reporting regulations and common violations leading to Warning Letter filings by FDA. As part of the review, actual Warning Letter and FDA-483 citations of small and large medical device manufacturers will be explored for Medical Device Reporting issues. There is a great deal of concern at FDA over the quality of the information  more...

Internal Audits Maintaining your Quality Systems at the Ready - Webinar By GlobalCompliancePanel Overview: While not captured in most audit reports, one of the biggest mistakes an organization can make is to have insufficient self audits. Internal audits are a core component of the Quality Assurance and Food Safety program. Ensuring the team representatives are trained and calibrated is a critical aspect of the program. An untrained team will miss important audit items, compromising the  more...

Operational Risk Management Ensuring Safety for Food Systems - Webinar By GlobalCompliancePanel Overview: With today's movement into more and more serious controls over food safety and security, the liabilities 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  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 Overview: This 3 hour Webinar is a primer and overview to the premarket notification process, i. e., a 510(k). A 510(k) is a premarket submission made to FDA to demonstrate that your device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device that is not subject to PMA. There are three types of Premarket Notification 510(k)s that may  more...

Design History File DHF Device Master Record DMR Device History Record DHR and Technical File TF - Regulatory Documents Explaine Overview: The FDA QSR and the Medical Device Directive specify certain documents or records that should be included in your organization's quality systems - Design History File (DHF), the Device Master Record (DMR) the Device History Record (DHR), and the Technical File (TF). Do you know what information should reside in a DHF, a DMR and a DHR? This Webinar will define, explain and clarify the  more...

New Changes to HIPAA The latest changes in the regulations and what they mean to you - Webinar By GlobalCompliancePanel Overview: 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...

Key Concepts in Successful Water System Sanitization - Webinar By GlobalCompliancePanel Overview: Though hardly a water system is designed and installed without some capability of sanitization, the system design features, materials of construction, sanitization approach, as well as the frequency of the sanitization process have everything to do with its success. This presentation focuses on the factors that can lead to water system sanitization success as well as failure so that  more...

Medical Device Tracking Latest FDA Update and Expectations - Webinar By GlobalCompliancePanel Overview: The Food and Drug Administration Modernization Act (FDAMA) requires that manufacturers track certain devices when the agency orders them to do so. Tracking is intended to facilitate notification and recall in the event a device presents a serious risk to health that requires prompt attention. The tracking provisions enacted by SMDA required mandatory tracking even if FDA did not issue  more...

Japan - Regulatory Filing Requirements and Compliance Processes for Life Sciences - Part I and Part II - Webinar By GlobalCompli Overview: This course specifically focuses on the overall regulatory compliance requirements and procedures for Pharmaceuticals, Medical Devices, Biologics and Combination Products in Japan. The course will cover topics relating to pre-clinical and clinical requirements, as well as, addressing the structure of the regulatory agencies in Japan. Content will also include descriptions of the  more...

FDA 483 Observations in the Laboratory What went wrong How can they be avoided - Webinar By GlobalCompliancePanel Overview: In order to proactively address areas of concern to the FDA and other regulators, All units within each pharmaceutical firm should review recent regulatory observations and proactively establish programs or systems to address the regulatory concerns. In this webinar we will focus on the laboratory and recent FDA laboratory based operations. We will review observations, identify the  more...

101 cGMP To-Do List for 2011 - Webinar By GlobalCompliancePanel Overview: This webinar will examine the broad range of issues a company's senior management and QA/ RA need to consider in their annual Management Review of their existing quality management system. 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)  more...

A Comparison of ICH Q-10 Quality System and the FDAs Quality Systems Approach QSA to the Pharmaceutical GMPs - Webinar By Global Overview: In September of 2006, the FDA published the Quality System Approach to Pharmaceutical Good Manufacturing Practices which provided a quality orientation to the GMP's Then in June of 2008, The International Conference on Harmonization (ICH) published ICH-Q10, Pharmaceutical Quality System. These guidance documents have provoked thought and raised questions about existing pharmaceutical.  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...

The Process Approach to Auditing - Webinar By GlobalCompliancepanel Overview: The structure of ISO 9001: 2000 provides a focus on the processes that comprise the quality management system (QMS). Also, the general requirements laid out in Clause 4. 1, the foundation for auditing a process-based system, are taken up for discussion at this webinar. There are eight basic processes that an organization must have to function effectively. These are: *  more...

Audit Committee Responsibilities for Internal Controls - Webinar By GlobalCompliancePanel Overview: With the advent of the Sarbanes-Oxley Act, audit committees are under increased scrutiny for helping management set the tone at the top and ensuring internal controls are documented and tested. As a matter of fact, the Audit Committee has the PRIMARY responsibility for oversight of internal controls. One thing audit committee member should expect is to have a clear understanding of  more...

Construct and Manage the Technical File and Design Dossier - Webinar By GlobalCompliancePanel Overview: This Webinar will provide a substantive overview and outline differences between the Technical File and Design Dossier for those device firms dealing with the global regulatory landscape. It is assumed that participants and customers have a prior CE Mark and Medical Device Directive background. The Technical File is a comprehensive collection of information and documents that details  more...

Introduction to Operational Risk - Webinar By GlobalCompliancePanel Overview: 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  more...

HIPAA Compliance and Workforce Training for Medical Practices - Webinar by GlobalCompliancePanel Training is required in a number of areas of the HIPAA regulations and their policy implementations at medical offices. The HIPAA Privacy Rule includes basic protections of uses and disclosures of protected health information that every staff member must be aware of, from avoiding discussion of patient-related information outside of the office, to taking precautions when faxing information to  more...

Training Requirements and Practices to Assure QSR and ISO Compliance - Webinar by GlobalCompliancePanel To satisfy QSR and ISO 13485 requirements as well as produce quality products, companies must assure personnel are trained on their routine job practices as well as familiar with requirements that impact them. A complete and effective employee training program must be in place to assure this. This session will instruct attendees on the regulatory requirements of personnel training, and  more...

How to Prevent Food Safety Problems Using Your Current Quality System - Webinar by GlobalCompliancePanel Most industries have become reasonably sophisticated in terms of applying the principals and tools involved in quality control and improvement. Unfortunately, food supply chain members have lived outside of the quality world and have not invested the time, training or money to learn and apply the disciplines needed to bring quality into preventive levels of control. Visual inspection in many  more...

Crisis Management and Risk Communication - Webinar by GlobalCompliancePanel As your company's system continues to grow, the potential for "crisis issues" to occur grows proportionally. The concern for food safety to your customers and employees must be a constant area of focus for all operators in the system. Ultimately, how well your company manages the crisis situations it will make a significant difference in how your company brand is perceived in the public's eyes  more...

Transfer of Analytical Methods FDA Expectations and Tools for Implementation - Webinar by GlobalCompliancePanel Laboratories that work in a GMP environment are required to have documentation to show they are qualified to run specific, consistent and reliable analytical test methods. Method qualification of a method can be achieved in three ways: Validation, Verification (Compendial Methods) and Method Transfer (company methods). Lack of such documentation can result in warning letters from both the FDA  more...

ICH Q7 Guidelines and Practical Approaches to Manufacturing APIs - Webinar by GlobalCompliancePanel Active Pharmaceutical Ingredient Good Manufacturing Practices (API GMP) are established and defined by the ICH Q7 Guidance. The international supply chain associated with API manufacturing was one of the greatest drivers for the development and international adoption of these expectations by regulators world-wide. The growth in the number of FDA inspections of API producers outside of the USA  more...

Revamping the 510k Clearance Process-Understanding FDAs Proposals - Webinar by GlobalCompliancePanel The FDA has proposed an overhaul of the 510(k) clearance system In its release of reports from two working groups, the FDA's goals are to increase the predictability and transparency of the 510(k) process and enhance FDA scientific decision-making. It will also increase the burdens on industry. For example, if finalized, there will be a new subclass of Class 2 products for which clinical  more...

The HITECH Acts Impact on HIPPA - Webinar by GlobalCompliancePanel The 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...

Using SLAs to Facilitate Enterprise and IT Governance Risk Management and Compliance GRC - Webinar by GlobalCompliancePanel This one-of-kind webinar is intended to provide you with practical guidelines on applying SLA concepts to your organization's GRC program. Organizations that have SLAs for GRC reap these benefits: * Ongoing improvements in their ability to identify, assess and prioritize risks * facilitates business owners involvement in risk management and GRC programs that affect them *  more...

Secrets of an Effective CMC Regulatory Strategy for Biopharmaceuticals Part 1 - Cell Banking - Webinar by GlobalCompliancePanel Cell banking assures that an adequate supply of equivalent well-characterized cells exist for production over the expected lifetime of the biopharmaceutical. Cell line development followed by preparation of the master/ working cell banks is an expensive process and needs to be done right the first time. Cell banks acceptable for early clinical trial material production have been found not to  more...

FDAs New Enforcement of 21 CFR Part 11 - Webinar by GlobalCompliancePanel FDA's 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...

Managing the IDE Investigational Device Exemption Submission for Compliance Success - Webinar by GlobalCompliancePanel An investigational device exemption (IDE) allows the investigational device to be used in a clinical study in order to collect safety and effectiveness data required to support a Premarket Approval (PMA) application or a Premarket Notification [510(k)] submission to FDA. Clinical studies are most often conducted to support a PMA. Only a small percentage of 510(k)'s require clinical data to  more...

Developing an Effective Supplier and Internal Auditing System - Webinar by GlobalCompliancePanel The FDA regulations contain a vast quantity of requirements, which govern tasks performed by your company's personnel every day. Are there going to be noncompliance? You bet. Are you going to correct these noncompliances? Only if you identify them. To ensure substantial compliance, your company needs an effective audit program for both internal and external processes. To have an effective audit  more...

Managing Product Medical Device Recall Efficiently and Effectively - Webinar by GlobalCompliancePanel Recall means the correction or removal of a device for human use where FDA finds that there is a reasonable probability that the device would cause serious, adverse health consequences or death. It is an action taken to address a problem with a medical device that violates FDA law. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective  more...

Robust Process Validation for Medical Devices - Webinar by GlobalCompliancePanel One of the most common reasons noted by the FDA for recalls of medical device is improper validation. It is also one of the most common reasons companies receive 483s and warning letters. Conversely, successful validations not only satisfy compliance and regulatory requirements, they also provide for robust manufacturing processes satisfying the needs of many individual functions within your  more...

Outsourced processes and ISO 90012008 - Webinar by GlobalCompliancePanel In 2008, a 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...

Learning from Recent FDA Warning Letters Related to Computer Validation and Part 11 - Prepare Yourself for the upcoming FDA Part On July 8, 2010, the FDA announced to soon conduct a series of inspections related to 21 CFR Part 11. FDA made it very clear that the focus of the inspections will on most critical issues the industry had with Part 11 in the past. The best way to find out what the issues are is to look at recent FDA 483 form inspectional observations and warning letters related to computer system validation and  more...

Verification of Pharmacopeia Methods - Webinar by GlobalCompliancePanel Laboratories that work in a GMP environment are required to have documentation to show they are qualified to run specific, consistent and reliable analytical test methods. Method qualification of a method can be achieved in three ways: Validation, Verification (Compendial Methods) and Method Transfer (company methods). Lack of such documentation can result in warning letters from both the FDA and  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...

Importing and Exporting Medical Devices A Primer on Regulatory Strategy and Requirements Any medical device that is legally in the U. S. may be exported anywhere in the world without prior FDA notification or approval. The export provisions under section 802 of the FD&C Act only applies to unapproved devices. Devices that have not been approved or cleared in the U. S. must follow the export provisions of the FD&C Act. Foreign firms that manufacture medical devices and/ or products  more...

Important Sterilization Information for Product Developers - Webinar by GlobalCompliancePanel Product developers have the responsibility of the development of medical devices or healthcare products that will be sterilized; however they may not have an adequate understanding of the sterilization processes and its impact to the functionality of the product and its package. This presentation will provide information that can be used by R&D Engineers and Product Developers to aid them in the  more...

Failure Modes and Effects Analysis FMEA - An Effective Tool for Medical Device Risk Management - Compliance Webinar by GlobalCom The presentation will discuss the proper use of FMEA in risk management and how to recognize and avoid the traps associated with this tool in order to have a more efficient risk management process.  more...

Risk Management in IEC 60601-1 Third Edition GlobalCompliancePanel brings a 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  more...

Design Planning and conducting Effective audits GlobalCompliancePanel brings a 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  more...

PCI Data Breaches What happened What may have prevented it What if it happens to you If your organization is struggling to meet compliance requirements for PCI, you're in good company. Unfortunately, in this case there is no safety in numbers. Criminals do not necessarily attack big companies; they go after whatever is easy. The cost of responding to a breach is getting more expensive each year. In this webinar you will learn about the current threat environment, how some of  more...

Adobe eLearning Suite Lodestone Digital provides public Adobe eLearning Suite classes across the country that are certified by Adobe. In addition to our public classes, we can provide Adobe eLearning Suite training at your location for students who need custom solutions. Our instructors have years of Adobe eLearning Suite production experience, and specialize in implementing digital media tools into a workflow.  more...

Advanced Regulatory Control and Optimization Online Certificate Program Several studies have shown that around 30 percent of industrial control loops can perform at much higher levels than they currently do. Optimizing control loops can be challenging, but it is greatly simplified with the right skills and know-how. This training course will equip you with the essential knowledge needed for optimizing the performance of your plant's controls. This training course will  more...

Excel at Filing - On-Demand Webinar The computer is an excellent organizing tool and yet the last thing clients want to do is buy more software. In this popular webinar, Certified Professional Organizer ® Debra Milne takes you through the different ways Microsoft Excel ® can be used to create an electronic filing system including electronic filing practices; printing file inventory lists; searching and tracking files;  more...

DOWNsizing - Its not Just Stuff Its MY stuff - On-Demand Webinar As a Professional Organizer, you may be asked to assist Seniors and their families with the task of condensing a lifetime of treasures into a smaller space. Baby Boomers have started to turn 60; working with Seniors may be the direction you are considering for your business. Discover basic tips, tricks and techniques you can apply as you help Senior clients journey through the emotional process of  more...

Business Broker Training Webinar Our online 1-on-1 training is our brand 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 -  more...

Communication Skills in the Workplace It is well known that before you come to work, you have to leave your casual self back home. In the office, you're an employee, someone who's supposed to go about his/ her work in the most professional manner. There is a way to talk to your superiors, to your peers and your subordinates. This method of communication is known as workplace communication and is typically formal and to the point. So  more...

ONLINE TIBCO TRAINING IN HYDERABAD Transient IT Services, Inc is a global IT solutions provider focused on delivering customer value through high Quality Processes and Cost-efficient solutions. Transient IT Services has been one of the trendsetters in global delivery practices with our Client-Centric Model for customer management and delivery. Established in 1999, Transient has grown to over 150 employees while establishing an  more...

ONLINE JAVA TRAINING IN HYDERABAD Transient IT Services, Inc is a global IT solutions provider focused on delivering customer value through high Quality Processes and Cost-efficient solutions. Transient IT Services has been one of the trendsetters in global delivery practices with our Client-Centric Model for customer management and delivery. Established in 1999, Transient has grown to over 150 employees while establishing an  more...

Improving Communication This course shows participants how to read other people and to see how others interpret their behaviors. It leaves them with a gut-level appreciation for the needs of their co-workers. Ultimately, the course helps participants adapt their communication styles in a way that creates an enduring working alliance among those you communicate with. This program is designed to help participants:  more...