Can Web-based Seminars

Understanding The Violent Mind In The Workplace As the economy continues to fall, workplace violence is expected to rise rapidly. The potential for workplace violence creates unique responsibilities for leaders. It continues to be a topic of concern among management.. As figures indicate, more than 2 million workers annually are victims of some kind of violent attack. Although statistics vary, it is estimated that as much as 30 percent of  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 ...ident Course: Date: This course is run twice a month but can be conducted at different times during the week; contact us for arrangements. This course can be conducted online and in Colorado. Corporate Course: If your company would like to have a course conducted for you at your location contact us to set it up and we will coordinate a time that works for you. We also offer remote courses  more...

Multivariate Data Analysis for Spectroscopy Applications Web Workshop This workshop has been designed to give participants a strong foundation in the basics and fundamentals of Multivariate Data Analysis and its applications for spectroscopy data. In this training you will learn how to pre-process your spectral data. You will also learn how you can interpret the Principal Components Analysis (PCA) and Partial Least Squares (PLS) loadings as signal.  more...

Interactive Analytics This Free Webinar is designed for Business analysts and developers to become familiar with using BIRT to design and develop Interactve Financial Dashboards and BI Applications with rich data visualizations. BIRT is a top level project within Eclipse and is the fastest growing open source reporting technology with over 5 million dowloads in the past 2 years. Actuate founded and continues to co-lead  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...

Mastering Microsoft Excel PivotTables Turn the tables on data analysis [WEBINAR] ...;ll learn what PivotTables are, how they work and how YOU can tailor them to fill your needs. Herea ™s a small sample of what youa ™ll learn: a how to take advantage of the calculation power of PivotTables. a how to create complex data comparisons. a how to quickly drill-down to specific sub-sets of data without returning to your source data or starting over. a  more...

Grow Spiritually Succeed Managerially Thinking is an art, a skill and one needs to practice it like a musical instrument or a sport. A successful manager or a leader must learn how to use this wondrous equipment in order to think, to reason and decide his / her course of action(s) in personal as well as professional life. Learning Objectives: History of human development, Intellect Vs Intelligence, Objectivity at work, 3 C's of  more...

Personalized Online Clinical Research Training for Clinical Research Professionals The content of the Online Training Program covers the Good Clinical Practice (GCP), the FDA and Health Canada regulations, the ICH Guidelines and gives numerous checklists and tips how to meet the job responsibilities. The course provides all the necessary information needed to be a successful Clinical Research Professional. The course can be personalized so that it fits your requests.  more...

Struggling to break into Clinical Research Free informative webinar about the CRA profession and the ways to break into the clinical research field. The webinar describes the pharmaceutical industry now and the future of the industry, the CRA job, skills and personality and how to break in the clinical research field. The session is live, so you can ask questions and get answers from the presenter, an experienced clinical research  more...

Listening for 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 they are in.  more...

LABOR RELATIONS TRAINING ...current collective bargaining agreement in terms managers can understand. We will cover concepts such as progressive discipline, effective handling of sick leave and tardiness abuse, the grievance procedure and how to ensure successful arbitrations of your grievance issues. Most importantly, we will teach your managers that they can and should still effectively manage their employees despite  more...

From Hiring To Firing What Every Manager Needs to Know ... Learn how to protect your company and yourself (managers can be held personally liable 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  more...

Top Tips To Prevent Workplace Violence in your Workplace ...f what constitutes workplace violence and examples of who can engage in workplace violence. It teaches you to recognize the warning signs that can lead to workplace violence and provides techniques and strategies to avoid violence in the workplace. This Workplace Violence Prevention Training makes you aware of situations that may pose a higher risk of workplace violence and instructs as to  more...

Employee Handbooks Dos and Donts ...y 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 should never use in such a handbook. This informative seminar will outline for you the dos and dona  more...

Top Tips For Managers to Prevent Harassment in your Workplace ...k Environment Harassment a Mistakes Managers Make that can Create a Hostile Work Environment in your Workplace a Tips For Avoiding a Hostile Work Environment a It's Not Just About Sex Anymore-Hostile Work Environments Based on Protected Classes Other than Sex a Tips to Avoid Retaliation Claims a Methods for Employers To Establish the Ellerth and Farragher Affirmative Defenses to  more...

TOP 10 TIPS FOR CREATING A BLOGGING AND SOCIAL MEDIA POLICY ...from the risks caused by social media and one that is not can be as simple as having a well-drafted social media policy. Learn the top 10 tips for creating a social media policy including the following: a Tips for Developing a Blogging and Social Media Policy a Doa ™s and Dona ™ts For What Should Be Included in the Policy a Blogger Beware! The Dangers of Failing to Draft Such  more...

HIRING DOS AND DONTS ...iability when hiring employees. Learn what questions you can and cannot ask during the interview process. Learn how to avoid asking questions that can lead to discrimination claims later on. Also, learn what employment-at-will really means and how to avoid losing your right to hire or fire at-will. Learn how to avoid claims of implied contract that lead to breach of contract and wrongul  more...

AVOID LEGAL PITFALLS OF DRAFTING JOB DESCRIPTIONS ...can and often are used in a court of law as evidence against an employer. Learn how to avoid the legal pitfalls of drafting these legal documents and best practices for drafting all of your job descriptions. This on-line live webinar will help you avoid legal problems related to the Americans with Disabilities Act, employment discrimination and employment-at-will. Sign-up on line now or  more...

Tips To Avoid Liability When Terminating Employees This live Webinar is a must for all employers. Learn how to protect your company and yourself in this workplace law guide to terminating employees that provides some top tips for avoiding liability. Nothing causes more problems for employers than terminating an employee. Attend this informative one-hour seminar to learn how to avoid the top mistakes that employers often make when terminating  more...

Tune Up Your Listening 2 webinars, each 90 minutes webinar #1 builds awareness of listening habits and their impact on communication. Participants take the assessment instrument, Hear! Hear? Your Listening Portfolio that describes their use of four different listening habits. Participants examine how they prefer to listen, their listening strengths and challenges, and the appropriateness of their listening habits at  more...

SOA BPEL Online Training ...ustry. 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 that each of the applications expose themselves as services that can talk  more...

Spring Web Flow ...pproach 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 framework, as underpinnings of the Web Flow system. Then we  more...

Customer Service over the Telephone This customer service training class teaches telephone courtesy and service. In this class, students will learn to provide high quality customer service over the telephone by improving their listening and questioning skills to clarify customer needs. Students will learn to create action plans to improve their customer service telephone skills so that they can provide excellent customer service  more...

Managing Business Risk This Managing Business Risk training course will help students identify special risk-management considerations for specific types of businesses and industries. It will also help students develop a strategic approach to risk, which, when understood across the organization, with commitment at the very highest level, can enhance a company ' s competitive advantage and contribute to the company ' s  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...

Advanced Photoshop CS4 Training In this Adobe Photoshop training course, students will learn advanced features of Photoshop CS4 that will help them work with the tool more efficiently and effectively. This course can also be taught using an older version of Photoshop.  more...

MOC 8820 - Payroll - US in Microsoft Dynamics GP 10.0 ...nality, this class also explains tips and techniques that can help make an implementation successful, and gain a more thorough understanding of the Payroll application and its capabilities.The Dynamics course covers the setup of the Payroll module. It covers the setup windows that are necessary to complete to start using Payroll, and the processing of Payroll checks, including information on  more...

MOC 8823 - Receivables Management I in Microsoft Dynamics GP 10.0 This Microsoft Dynamics GP training class teaches the features and benefits of using the Receivables Management module in an integrated environment. Students learn how transactions can be entered and posted in Receivables Management, to maintain your Receivables Management records, and to handle processes that are completed at the end of the month, period, calendar and fiscal year.  more...

MOC 8824 - Sales Order Processing in Microsoft Dynamics GP 10.0 This Microsoft Dynamics GP Sales Order Processing class explores the accounting cycle and the processes required to enter and ship sales orders. This class shows you how to easily manage the life-cycle of your customer ' s order from the initial quote to the shipment documentation and final invoicing. You learn how to perform additional functions setting up process holds for quality assurance and  more...

MOC 8885 - Human Resources in Microsoft Dynamics GP 10.0 ...nctionality, you will also learn tips and techniques that can help make an implementation successful, and you will gain a thorough understanding of the HR application and its capabilities.The HR class covers the setup of the Human Resources module. It covers Employee maintenance and recordkeeping in Human Resources. It also covers the Applicant functionality found in Human Resources so you can  more...

Java EE Seminar for Managers ...tform; how it is deployed and put into production; how it can be administered. The course is designed specifically for non-programmers -- analysts, managers, technical writers, and anyone who desires a good conceptual understanding of Java EE while not needing to drill down into the details of particular APIs or runtime specifications. Developers may also find this course quite useful as a  more...

Managerial Leadership Training This Managerial Leadership training course teaches students about organizational leadership and its role in guiding the organization toward vision fulfillment. Students will learn how to define an organization ' s vision, draft a vision statement and communicate it, set goals that are aligned with an organization ' s vision, and discuss the importance of planning changes before implementing them.  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...

Introduction to Adobe Illustrator CS4 Training This Adobe Illustrator training course introduces students to the basics of Illustrator. It is packed with hands-on exercises so that students can learn by doing.  more...

Advanced Inter-Personal Communication Training This Advanced Inter-Personal Communication training course teaches students about interpersonal communication styles and techniques. Students learn how to ask and answer questions, use nonverbal communication, give feedback, and empower employees. Students also learn how to communicate with individuals who hold different positions in an organization, such as peers, supervisors, subordinates, and  more...

Database-Driven Websites with Dreamweaver CS4 This Dreamweaver training class teaches students how to use Dreamweaver CS4 to build dynamic database-driven web sites. These sites can be built using ColdFusion , PHP or Active Server Pages.  more...

SharePoint 2007 Governance Training This SharePoint training course covers the ins and outs of governance in general as well as common taxonomies. You will review what a Governance plan is made up of, as well as learn how to create a training plan, SharePoint service offerings and how to follow through with enforcing the plans. We will review Information Architecture and why it is important.We will take a look at each level in  more...

Introduction to Captivate 4 Training This Captivate training class will introduce you to the essential Adobe Captivate 4 skills you need to know to get up and running with Captivate as quickly as possible. Using Adobe Captivate 4, you can capture screen shots on your computer and quickly turn them into lessons or movies. The movies you create can be interactive and you can add images, captions, rollovers, clickable areas, typing  more...

Business Problem Solving and Strategic Decision Making This Business Problem Solving training course teaches students the fundamentals of solving business problems. This course introduces students to the need for problem solving, ineffective responses to problems, the elements of an effective solution, and the skills needed for effective problem solving. Students will also learn how to avoid inappropriate responses to problems, identify types of  more...

Adobe Acrobat 9 Training This Adobe Acrobat 9 training course takes students through all the major features of Adobe Acrobat 9 Pro. It is packed with hands-on exercises so that students can learn by doing. Students will learn to create, edit and manipulate PDF files, to combine files into portfolios, and to secure PDF documents. They will also learn how to work with many of the advanced features of Adobe Acrobat 9.  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 Microsoft Access 2003 Training ...d the advantages that using a relational database program can bring to their business processes. The introductory Access course is for the individual whose job responsibilities include working with tables to create and maintain records, locate records, and produce reports based on the information in the database. The course also provides the fundamental knowledge and techniques needed to  more...

Introduction to Visual Studio .NET Introduction to Visual Studio .NET provides you with a solid background on Microsoft ' s .NET technology so that you can decide whether it is appropriate for your next project and how it can integrate into an enterprise.  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...

Strategic Decision Making Training This Strategic Decision Making training course teaches students how to plan, frame, and research decisions. Students learn how to define decisions, apply appropriate decisions frames, avoid overconfidence, deal with uncertainty, generate options and select the best one, develop numerous high-quality options, evaluate the options and make a final choice, review and learn from experience, identify  more...

Motivation Training In this motivation training course students will discuss the foundations of motivation. They will examine motivating and demotivating factors as well as negative thoughts. They will also discuss motivation theories and the benefits of motivation. Students will examine the concept of having a Positive Mental Attitude, and how they can work towards a PMA in their lives. During this course, students  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...

MOC 5118 - Maintaining and Troubleshooting Windows Vista Computers This Windows Vista training class provides students with the knowledge and skills to successfully maintain and troubleshoot Windows Vista computers.It will provide them with the knowledge and skills necessary to identify technical problems that can occur in an organization  more...

MOC 2433 - Microsoft Visual Basic Scripting Edition and Microsoft Windows Script Host Essentials This VBScript training class provides students with the knowledge and skills to manage Windows networks by using the Windows Script Host (WSH) and the Microsoft Visual Basic, Scripting Edition (VBScript) language. During the class, students will work on real-world scripts that they can use to manage computers running Windows Vista, Windows XP, and Windows Server 2003 operating systems. This class  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...

Certified Eco Green Consultant Training Program GoEco Certified had developed the nations best & most comprehensive Certified Eco Consultant Training Program to help future Eco Consultants provide a valuable service within their community helping Homes/ Businesses GO GREEN! Green Consulting is a rewarding carrer that can be either part time or full time. All of the Eco Consultants are actual Certified Eco Consultants in the field doing exactly  more...

Measuring Performance of Your Global Procurement Organization How to Shape Behaviours in Global Purchasing ...cessary to properly calculate a cost reduction curve that can be used to predict total material costs. - Methods for determining how a 1% reduction in purchase-spend translates into changes in enhanced profits, reduced gross assets and improved enterprise valuation. - How should procurement function metrics be aligned with other metrics in a global sourcing manufacturing company and how do  more...

How to Factually Evaluate Critical Supplier Performance and Risks ...ufacturers 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...

Constructing a Component Criticality Matrix A Better Way to Identify Important Components ...re often responsible for managing thousands of parts that can be purchased from hundreds of Suppliers. The large number of parts and Suppliers makes it nearly impossible to manage each individual part as much as one wants to. This is why Procurement organizations rely upon stratification methods and other sorting methodologies to provide insights into GROUPS of parts. This way, the  more...

How to Achieve Maintain ERP Systems Master File Data Integrity ...binar focuses on the following THREE critical issues that can ultimately determine the effectiveness of an integrated information systems environment: 1. How to measure, monitor and report the completeness of master file data and system operating parameters. 2. How to measure, monitor and report the accuracy of key master file data elements, and 3. How to measure, monitor and report  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...

Integrative Activity Based Costing Leadership An Overview of Bottom Up Cost Accounting ...s: 1. To demonstrate how a bottom-up version of ABCA can be used to better allocate support costs. 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  more...

A Case for Routine Use of Statistical Process Control SPC in Manufacturing ...ing the underlying cause(s) before the predicted failures can manifest into real failures. SPC represents a progressive set of predicted and predictive technical tools that any individual can use to diagnose probable causes of predicted process failures and then systematically determine alternative solutions. Most manufacturing company executives, managers, and front-line supervisors have,  more...

Demystifying the Calculations of Efficiency Utilization and Productivity ...las, we will explain how values derived from the formulas can be altered and how companies can benefit from the CORRECT understand of these terms. We will clearly show participants HOW to calculate these values and WHEN to use the results of the measurements. Though this webinar presents a seemingly simple topic, the correct understanding and use of efficiency, utilization and productivity  more...

How to Calculate the Impact on Total Factory Costs from a One Percent Change in Planned Load ...and techniques, specifically focusing on how your company can come to an understanding of what a 1% change in planned load means to profitability and enterprise value. We will discuss: a How to calculate the impact on profits derived from a 1% change in annual planned load. a What costs are included in variable, semi-fixed and fixed cost categories overcoming myths of  more...

How The Manufacturing Industry Can Save Americas Economy ... economy is in trouble and only the manufacturing sector can save it! It is clear that Americaa ™s competitiveness on the global economic stage is diminishing. This is more than a feeling. It is supported by industrial productivity data, product ramp-up analyses, commercial employment statistics, comparative trade balance values and international industrial liquidity data. After 60  more...

New Final HIPAA Amendments New final rules for HIPAA Expand the Scope and Increase Responsibilities ...dividuals have access to their records, and how much they can find out about who has accessed their records. Find out about how Individuals can now request certain restrictions on disclosures that you must honor. Learn about the new requirements for disclosers of health information to apply "minimum necessary" standards. Understand the new requirements for Business Associates to comply with  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...

Risk Analysis for Portfolio of Drug Development Programs - Webinar By GlobalCompliancePanel Building in strategic risk scenarios into portfolio planning can buffer the organization against the unexpected. Examples might be clinical trial failure, shifts in the marketplace or insufficient resource capacity. This webinar covers various portfolio planning tools and techniques with a focus on strategic risk management. Thursday, February 2, 2012 10: 00 AM PST | 01: 00 PM EST  more...

FDA 483 Observations in the Laboratory What went wrong How can they be avoided - Webinar GlobalCompliancePanel 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. Tuesday, January 10, 2012 10: 00 AM PST | 01: 00 PM EST  more...

A Practical Look at Discipline and Termination - Webinar By TrainHR This webinar takes a practical look at discipline and termination as part of effective performance management. You'll learn about different kinds of discipline policies and some of the legal implications of using discipline. You'll also explore some best practices for deciding: when and what kind of discipline to use, how to document it, and how to implement it. Importantly, you'll also look at  more...

Documenting Performance and Administrating Progressive Discipline - Webinar By TrainHR This webinar will cover discipline policies, standards of conduct, and the process of documenting performance and administrating progressive discipline, up to and including termination. It will also cover the objectives of discipline, the reasons for substandard performance, investigating circumstances and documenting discipline, the difference between counseling and coaching, when you can  more...

Clean Room Microbial Load and Characterization of Microorganisms in the Clean Room Environment - Webinar By GlobalCompliancePane ... be covered, and a review of types of microorganisms that can be present, will be discussed. A general review of environmental niches where they may be present will be discussed. You will be introduced to the different methods available to conduct testing. Key areas discussed will be Compressed Air, Personnel Monitoring, Surface and Raw Material Monitoring. Recommended selection of sampling  more...

Calculating Overtime Correctly - Webinar By TrainHR ...an 385, 000 workers. Penalties for overtime violations can be severe with the possibility of fines, imprisonment or both! Add civil suits to the mix and the results can be devastating to any business no matter how large or small! Learn how to protect yourself and your company by joining renowned payroll expert Vicki M. Lambert in this information packed event! Areas Covered in the  more...

Disaster Preparedness - How to be prepared for the unexpected - Webinar By mentorhealth Are you prepared enough to survive, let along successfully recover from a disaster? The physical devastating possibilities that can happen to your practice include fire, flood, earthquake, hurricane, tornado, tsunami, or worse. Wednesday, October 5, 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...

Excel Spreadsheets and FDA Device Regulations - Webinar By GlobalCompliancePanel This seminar 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. Thursday, October 20, 2011 10: 00 AM PDT | 01: 00 PM EDT  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...

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 ... regulatory agencies have stated that software validation can realistically only be accomplished effectively if "risk-based". How can this be accomplished in the "real world". This webinar will address software that is supporting the company's Quality System and cGMP documentation. It will assist in evaluating software vendor claims to separate compliant software from "vaporware". A  more...

Practical Laboratory Statistics ... we will focus on the concepts of statistics, and how you can use these concepts to interpret your laboratory results. Our focus will be on using basic spreadsheet functions to compare data sets generated from many different kinds of test equipment. Why Should You Attend: Most people hate statistics, because they don't understand statistics. If you either generate or review laboratory data,  more...

FDA Inspections - Dos Donts - webinars by gcp 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 - 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...

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...

Validating Radiation Sterilization for Medical Device Industries by gcp ...irements and integrating them early in the product design can lead to quicker time to market. This seminar will help RA/ QA staff understand the basic principles as well as the standards and regulations. This will be useful when reviewing validation plans, performing internal audits and dealing with regulators. It is also beneficial to R&D staff to understand the requirements so they may be  more...

W-2s 1099s Independent Contractors Protect Yourself with Proper Classification by TrainHR Understanding proper classification requirements and helping to guide your company through this sensitive and important decision can be one of the most valuable and beneficial services that payroll departments can provide to the organization. Can you be relied upon to make those determinations correctly?  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...

Breakthrough Performance Management that is Practical Effective and User-Friendly ...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 performance of subordinates by giving the right information, direction, and support they need to do  more...

Auditing and Administrating Human Resources Policies and Practices by TrainHR ...wed 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 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  more...

Dress Code Nightmares How to Deal with them and How to Prevent them by TrainHR This practical webinar teaches HR professionals and small business owners how to avoid harassment or discrimination claims that can arise from poorly handled - or inconsistently enforced - dress code issues. It provides specific guidance on how to talk about some of the most difficult topics there are - body odor, inappropriate dress, an unkempt appearance, etc.  more...

How to Conduct an Offensive Behavior Investigation by TrainHR ...imination 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 learn what the courts require with regard to a prompt thorough investigation. Become familiar with what your goals should be in the investigation and what the  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...

Emotional Intelligence What it is and Why it Should Matter to You by TrainHR The most important "e-term" you may learn in 2011 is emotional intelligence. Experts say it can make or break careers and elevate executive leadership to higher levels of success, so what are the best moves and worst emotional pitfalls you can make? Learn from executive coach and nationally acclaimed author Arnold Sanow what it is and why it matters to the success of executives and the companies  more...

The 510k Submission Requirements Contents and Options - Webinar by GlobalCompliancePanel Overview: This presentation will provide an understanding of how to get a device requiring a 510(k) submission to market quickly. Knowing when and how to properly submit a 510(k) for a device or change to a device is critical to a company's regulatory and financial health. Your goal is to get the 510(k) through the review process as quickly as possible. This presentation will also distinguish  more...

Device Changes and the 510k - Webinar By GlobalCompliancePanel The majority of medical devices are cleared for marketing in the U. S. by the FDA under the 510(k) process. 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  more...

Understanding good Closed Loop CAPA system - Webinar By GlobalCompliancePanel ...can pursue continual improvements and address the concerns of non-conformances and develop corrective/ preventive actions to prevent the repetition of these occurrences in the future. Increased regulatory pressures, the latest customer mandates and internal quality initiatives are requiring companies to take a proactive and automated approach to their corrective action process. In addition,  more...

HIPAA Enforcement and Compliance Audits What the auditors want and how to be ready before they call - Webinar By GlobalComplianc ...documentation needs to be prepared in advance so that you can be ready for an audit without notice. Sample information request forms and questions asked at prior audits will be presented. The session will also cover how to know if you may become the subject of an audit or enforcement action, and what you can do to help limit your exposure. We will discuss how most enforcement actions come  more...

DHF DMR DHR Technical File and Design Dossier - Key Requirements and Future Directions - Webinar By GlobalCompliancePanel ...TF/ B9DD. Being aware of the similarities and differences can further concurrent development and/ or updates to both Areas Covered In the Session: * The U. S. FDA's DHF * The EU's MDD and the Technical File / Design Dossier * Design Control vs. a Product 'Snapshot in Time' * DHF "Typical" Contents * TF / DD Expected Contents * Parallel Approaches to  more...

HIPAA Security Policies and Procedures Making them useful and relevant as well as compliant - Webinar By GlobalCompliancePanel ...t also in less obvious places such as copiers, printers, scanners, cell phones, and portable data devices. All entities covered under HIPAA must take special care of electronic patient health information, including establishing policies and procedures to protect all kinds of PHI and taking regular actions as part of a security management process. Proposed changes and expansions to HIPAA,  more...

Information Security and Payment Card Rules Protecting Patient Payment Data and Complying with PCI - Webinar By GlobalCompliance ...es to limit exposures under PCI and HIPAA, and what steps can be taken to help limit the scope of compliance for PCI by keeping payment card information off of your office networks. Attendees will find out what they can do to minimize the payment card information they keep, restrict where it goes and who in their organization needs it, and minimize their obligations under the standard.  more...

Information Security Risk Analysis Meeting HIPAA Requirements and the Meaningful Use Objective - Webinar By GlobalCompliancePane ...s and recommendations for each system or information flow can then be described and organized into a table that is used to define the risks and prioritize their mitigation, using a straightforward high-medium-low stratification of potential likelihood and impact for each risk issue, following the risk determination method identified in the preamble to the HIPAA Security Rule and guidance from  more...

Pharmaceutical and Medical Device Validation Guidances - Similarities and Differences - Webinar By GlobalCompliancePanel ...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 application to all medical products. They will better understand the importance of their role not only in maintaining the process but also in helping diagnosis and treatment of patients more  more...

Auditing an Active Pharmaceutical Ingredient API Contract Manufacturing Organization CMO - Webinar By GlobalCompliancePanel ...r biological material. You are purchasing a material that can carry with it hidden risks if not properly examined and controlled. Such examination is not always productive if you rely simply on testing protocols. You need to learn where to look and what to focus on during any on-site audit. While understanding the applicable GMP is important, how to apply the GMP and what to establish with a  more...

Develop and Execute the Company Software VV Program - Webinar By GlobalCompliancePanel ... regulatory agencies have stated that software validation can realistically only be accomplished effectively if "risk-based". How can this be accomplished in the "real world". This webinar will address software that is: * As-Product * In-Product * In Production and Test Equipment and * The Quality System A manufacturer is responsible to identify these requirements and  more...

Root Cause Analysis - The Heart of a Successful CAPA Program - Webinar By GlobalCompliancePanel ...nce, and is also a key source of regulatory problems. How can companies allocate scarce resources to those activities that have the greatest impact to product quality / safety, minimize resources on minor issues, and still satisfy the regulatory agencies? How can line operators' brains be engaged by the use of such simple yet powerful tools? Use RCA to facilitate a closed-loop problem  more...

Internal 21CFR Part 11 Compliance Auditing of Computer Systems - Webinar By GlobalCompliancePanel ...1." These words from an FDA or state regulatory inspector can send shivers down your spine. Are you ready for an internal QA or FDA inspection at your site? Areas Covered in the Session: * 21CFR Part 11 Compliance * Review of the regulations * Regulatory requirements * Site Inventory * Compliance Assessment * Risk Assessment Who Will Benefit: The employees  more...

Design History File DHF Device Master Record DMR Device History Record DHR and Technical File TF - Regulatory Documents Explaine ...ur device? Is your DMR accurate and is it being followed? Can the operators access your DMR? Are you recording and documenting all your production and testing data and maintaining them in the DHR? Areas Covered in the Session: * FDA Quality Systems Regulation Requirements/ Definitions * MDD Requirements/ Definitions * Design History File (DHF) o Definition  more...

The Most Common Problems in FDA Software Validation Verification- Webinar By GlobalCompliancePanel ...ity systems means increased exposure. * Most recalls can be traced back to computerized equipment, exposing the validation process to scrutiny. * A third of recent warning letters included citations with respect to improper or ineffective validation. * Many companies struggle with understanding how to avoid major mistakes when validating software to FDA standards. This  more...

The Science Of Recruiting Interactive Video Based Training The Science of Recruiting Video Based Training is a comprehensive course containing practical skills workshop and tailor made video course that is designed to do the following: 1. Improve your interview skills 2. Dramatically reduce your recruitment mistakes 3. Provide you with practical tools that you can to put into practice right away and enjoy the results  more...

How to successfully create a Device History Record and keep FDA happy in the process - Webinar By GlobalCompliancePanel ... to record keeping is performed by FDA. * How Change can affect DHRs. * Learn what constitutes a good DHR procedure. * Learn how risk management fits into DHR compliance. * Learn how to better audit quality record systems. Areas Covered in the Session: * Introduction * Guidance documents/ QS regulation * Major FDA 483 points * Trends in FDA warning  more...

Data Security Analysis for Healthcare Providers - Webinar By GlobalCompliancePanel ...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 risk analysis requirements * Methods for building a customized analytical tool * Questionnaires  more...

Webinar on Cloud Computing SaaS - Webinar By GlobalCompliancePanel ...s what drives SaaS system compliance and how requirements can be limited to Customer specific configurations. The scope of the validation effort will be explained and the elements of the Validation effort will be outlined. Change Management will also be discussed, with regards to how Vendor changes and customer configurations affect the validation and the testing that will be required to  more...

Understanding Attribute Acceptance Sampling including Z14 and c0 Plans -- Webinar By GlobalCompliancePanel ...upplier management program * How the switching rules can help you reduce inspection cost The c=0 plans are very popular, since they are based on the notion that everything in the sample should pass inspection. The course examines these plans using the curves described above. The OC curve, in these plans, has a different shape that can lead to problems. We will discuss the following  more...

Requirements of the Master Production Record - Webinar By GlobalCompliancePanel ...ns. Failure to recognize and implement those requirements can have devastating effects on your company's quality system, including production and manufacturing controls. The purpose of this webinar is to provide attendees with the mandatory compliance requirements for the master production records. Applicable areas may include clinical, technology transfer, and routine manufacturing and  more...

Best Practices for the Implementation and Use of Test Management Tools - Webinar By GlobalCompliancePanel ... involved in a traditional paper-based validation project can attest to the ability to manage the validation deliverables, timelines, resources, tasks and the compliance of the project can be difficult, resource extensive and time consuming. Most paper-based validation practices require many documents that are managed both electronically (in multiple systems) during development, review,  more...

FDA Clinical Trial Auditing and the due diligence Companies should conduct as part of their monitoring program - Webinar By GCP ... monitoring system will be presented so that participants can assess their current practices for identifying gaps and risks, particularly in relation to preparing for regulatory inspections. It will be important to see what the FDA regulations and the ICH GCP recommendations are in this regard. The key is that the PI and all clinical staff know and follow the research plan (Protocol) exactly  more...

Online Personal Financial Management Coaching ...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: - Personal  more...

Gowning Systems Used in Cleanrooms Controlled Environments - Webinar By GlobalCompliancePanel ...control capabilities. The use and donning of the garments can also vary and needs to be controlled in order to establish a consistent manufacturing environment. Areas Covered in the Session: * Identify what garment systems are available. * Identify and discuss good and bad cleanroom gowning. * Identify gowning techniques and sequence. * Discuss what role each garment  more...

Facilities Cleaning in Cleanrooms and Controlled Environments - Webinar By GlobalCompliancePanel ...le in cleanroom management. Poor or substandard cleaning can result in manufacturing delays, nonconformances, recalls, and regulatory action. Therefore it is important to control cleanroom cleaning processes and ensure best practices are followed. Areas Covered in the Session: * Learn about cleaning and what it accomplishes in the cleanroom. * Identify cleaning agents, tools,  more...

The Pharmaceutical Quality System - Webinar By GlobalCompliancePanel ...The various FDA and ICH guidance documents provide significant clues as to what should be in a Pharmaceutical Quality System. Regulatory guidance's, as well as contemporary quality standards, reference life cycle, management responsibilities, knowledge management, risk management, quality by design and many other concepts. Individuals in pharmaceutical firms, from the highest executive to  more...

A Comparison of the Pharmaceutical and Medical Device Good Manufacturing Practices - A Study of Similarities and Differences - W ...ty based systems. An understanding of this paradigm shift can be gained by comparing the compliance based Pharmaceutical GMPs with the Medical Device Quality System Regulation. ICH-Q7A will be included because it is a cross between the quality and compliance approach. This webinar will explore differences and similarities between these GMPs as well as show how they relate to other quality  more...

Elements of the Lot Disposition Process - Webinar By GlobalCompliancePanel ...u attend: The process for the disposition of product lots can be tedious and overwhelming. The requirements for intermediates, Active Pharmaceutical Ingredients (API), drug substances, medical devices, finished product, and even in-house manufactured components must meet certain specifications and/ or regulatory requirements to ensure the identity, strength, quality and purity of the lot. The  more...

Controlled Substances and the Hospital Pharmacy - Webinar By GlobalCompliancePanel ...lled substances in a hospital setting and what steps that can be taken to detect and prevent the illicit use or diversion of any controlled substance. Objectives of the Presentation: The following areas are covered: * DEA Office of Diversion Control: This section will familiarize you with the authority given to DEA Diversion Group when enforcing the laws and regulations pertaining to  more...

HIPAA Breach Notification What to do to prevent breaches and what to do when they happen to you - Webinar By GCPanel ...ification 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 respond to a breach  more...

Regulatory Complaint Handling Vigilance Recalls - Webinar By GlobalCompliancePanel ...can result is serious regulatory problems as well as hitting the bottom line. Recalls, FDA Warning letters & even seizures could result. This presentation will review the regulatory requirements for complaint handling and adverse events reporting in the USA, EU & Canada. Suggestions for investigating and documenting complaints & pitfalls will be included. Areas Covered in the Session:  more...

Developing the Risk Management Plan - Webinar By GlobalCompliancePanel ...mation collection activities. While Risk Management Plans can be part of the Quality Plans for a product, important characteristics of the Risk Management Plan must be documented to meet requirements. In situations where development and manufacturing activities are located in different areas and are under different management structures, the Risk Management Plan must document the divided  more...

FDAs New Process Validation Guidance - Webinar By GlobalCompliancePanel ...he drug, API, or biologics industries (or their vendors!) can afford to miss this presentation; while validation personnel in the medical device, tissue processing, and dietary supplement fields will find it informative and useful. Why should you attend: FDA has stated that the principles in the new guidance are directly supported by regulation, law, and current best practices, and expects  more...

Recruiting is Critical to Your Success What is the Secret - Webinar By GlobalCompliancePanel ...CRO's, the sponsors must also know what is needed so they can chose the right CRO or research site to conduct their studies. Areas Covered in the Session: * How to set up and track your recruiting of subjects * The challenges of successful recruiting * The importance of your recruiting staff in the overall success of the unit or site * How to build a data-base of  more...

Understanding the Calibration Curve - Webinar By GlobalCompliancePanel ... only one option for the evaluation, and why sometimes it can give a false indication of the curve fit. Finally, we can illustrate these concepts by examining several real-world data sets from a variety of different analytical instruments. Why should you attend: Everyone who works with analytical data is working with a calibrated measurement system. However, few people really understand the  more...

Process Validation for Medical Devices - Webinar By GlobalCompliancePanel ...eful design and validation of the process, a manufacturer can establish a high degree of confidence that all manufactured units from successive lots will be acceptable. Successfully validating a process reduces the dependence upon in-process and finished device testing. Routine finished device testing is often insufficient to assure product quality. In some cases, destructive testing is  more...

How to use QSIT to Your Advantage - Webinar By GlobalCompliancePanel ... going to look at when (s)he performs his/ her audit, how can you really know what to prepare for? Even a thorough internal audit may not focus on the areas that the FDA inspector will. The most effective way to increase the likelihood of your internal audits identifying issues that the inspector will see is to arrange your internal audit scheme to mimic the process the FDA inspector will use.  more...

Purchasing and Supplier Controls in the Medical Device Industry - Webinar By GlobalCompliancePanel ... 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 supplier evaluation and assessment, and provide cost efficient, equally compliant options to many of the most common practices. Why you should attend: A  more...

Preparing for Pre-approval Inspections - Webinar By GlobalCompliancePanel ...row window of time during which the NDA/ BLA/ ANDA holder can demonstrate to the FDA that the quality systems at the site are in compliance with the GMPs and that appropriate facilities are available to support manufacture of the product. It is therefore important to present the organization in the best light possible. Areas Covered In the Seminar: * Pre-Approval Inspections *  more...

Off-Label Promotion of Drugs - Regulatory Documents Explained - Webinar By GlobalCompliancePanel ...guidance places regulatory constraints on how information can be disseminated and limits the types of materials that can be distributed. Why you should attend: This presentation will address both the regulatory and products liability consequences of off-label promotion. It discusses the fundamentals of off-label promotion and provides risk management tips to help companies prevent off-label  more...

XML Training ...ull schema file Other ways of writing the schema XML Canonical Data Model What is Canonical Data Model Use of Canonical Data Model Example of Canonical Data Model 1. INTRODUCTION TO XPATH What is XPath? Where is XPath used? Pre-requisites for learning XPath Path expressions Standard functions 2. NODES IN XPATH What is a node in XPath? Types of nodes in XPath  more...

Project Management for Clinical Trials - Webinar By GlobalCompliancePanel ...ues 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 and techniques a checklist of over 100 clinical trial activities for a clinical trial will be supplied as part of the seminar, which will include the following: * Obtain a brief from the Project Sponsor which defines  more...

Meet FDA Expectations for a Tougher Supplier Audit Program - Webinar By GlobalCompliancePanel ... its suppliers of services and products / components. How can companies address the FDA's stated desire to require "on-site" audit of all Pharma suppliers? Expectations for meaningful, results driven actions that addresses and resolve any underlying compliance issues or product problems are increasing among regulatory agencies worldwide. To meet the new regulatory climate and be competitive,  more...

Developing and Using the Product Risk Management FileReport - Webinar By GlobalCompliancePanel ...gement tools. Effective use of such risk management tools can help address the growing push by the public and the FDA, to "toughen" its approach to product clearance and approval, while reducing liability issues. Why you should attend: The U. S. FDA has stated that the use of a medical device or pharmaceuticals entails some degree of risk. In fact, any medical procedure / intervention does.  more...

Change Control -- Your Companys GMP Weak Point - Webinar By GlobalCompliancePanel ...mpany and its change control policies and systems. Change can be beneficial, but is often the cause of new and even worse problems than those the change was designed to eliminate. It can be the root cause of a major problem, cGMP "entropy". Proper change control is required to resolve any underlying compliance issues or product problems that are increasingly seen by regulatory agencies and  more...

Excel Spreadsheets and FDA Device Regulations - Webinar by GlobalCompliancePanel ...ions 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 you want. We explain the built in Validation tools and how to  more...

Process Validation current industry practices and FDA Guidance Document Review - Webinar by GlobalCompliancePanel ...roduced variation in a process and shows that the process can consistently produce a quality product. Writing and executing good process validation can be a daunting task given the complexities of today's biotech and pharmaceutical processes. Guidance's are helpful in writing process validation protocols and deciding what can be, or should be, varied in the process. The notions of critical  more...

Understanding the Technical Requirements of 21 CFR Part 11 - Webinar by GlobalCompliancePanel ... 11 has been around for over a decade, lack of visibility can sometimes render compliance with this regulation an afterthought. Due to serious inefficiencies and non-conformance issues associated with trying to address Part 11 late in the system lifecycle, it is important to give the technical requirements due consideration early in the process. A good understanding of these technical  more...

Practical Laboratory Statistics - Webinar by GlobalCompliancePanel ... we will focus on the concepts of statistics, and how you can use these concepts to interpret your laboratory results. Our focus will be on using basic spreadsheet functions to compare data sets generated from many different kinds of test equipment. Why Should You Attend: Most people hate statistics, because they don't understand statistics. If you either generate or review laboratory data,  more...

Effective Corrective and Preventive Actions CAPA 10 Steps to Success - GlobalCompliancePanel Virtual Seminar - Webinar By Global ... it is represented in a practical and proven manner which can be immediately applied in your organization. Areas Covered in the Seminar: * Module 1 o Introduction and Overview o Correction vs. Corrective Action + Understanding of all elements of CAPA process step as required by ISO and regulatory agencies + Introduction to CAPA  more...

21 CFR Part 11 Complete Manual For Compliance Success - GlobalCompliancePanel Virtual Seminar - Webinar By GlobalCompliancePanel ...Audit Trails play major role in Part 11 compliance - they can be your best friends and/ or worst enemies at the same time. Areas Covered in the Seminar: * Module 1 - Overview and Understanding of the Regulation o Introduction and development of the regulation o What to expect in the future when it comes to the regulation o Options for (non)compliance  more...

Utilizing Good Requirements as a Foundation for the Effective Validation of PDMA-related Computerized Systems - Webinar By Globa ...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 level of effort. However,  more...

Controlled Substances and the Pharmacist - Webinar By GlobalCompliancePanel ...cuss the types of federal criminal and civil actions that can be imposed on a pharmacy pertaining to the purchase, sale, transfer, dispensing, destruction and theft or loss of Schedules II through V controlled substances. * Identify the responsibilities of DEA through their Diversion personnel to enforce federal laws and DEA regulations on the dispensing of controlled substances through a  more...

Hazard Analysis vs FMECA Differences and Commonalities - Webinar By GlobalCompliancePanel ...are often used synonymously. However, there are significant differences in both methodologies and their strengths can be combined to ensure a safe and efficacious system design. The presentation will explain both methodologies and will show ways how these tools can be used to complement each other. Additionally the differences and limitations of both methods will be illustrated and the  more...

Validating Excel and Word Applications Documents - Webinar By GlobalCompliancePanel ...ns programs, e. g., MS-Excel and MS-Word, or similar. How can these be verified and validated? Company quality data must be more "science based". What V&V (verification and validation) planning steps are expected under the CGMPs and other guidance documents for such apps software? How can these consistently be executed? Where does ISO 14971, ICH Q9, and similar risk management systems come in?  more...

Project Management in a cGMP Environment - Webinar By GlobalCompliancePanel ... common Excel- or Word-type PC applications programs that can be used immediately. Regular use of a few simple but powerful tools will virtually eliminate "fire fighting" in a new project. Regular use can contribute greatly to reduction of scheduling uncertainty, incomplete projects when time is running out, increased product liability, assist in company-wide cost reduction efforts, with less  more...

Legal Risks in Social Media for Healthcare Providers - Webinar By GlobalCompliancePanel ...e rules that impact the manner and method with which they can use social media tools, particularly related to HIPAA and other medical privacy concerns. However, it is possible to pursue a social media strategy while abiding by the legal and ethical constraints on healthcare industry participants. This seminar will address the social media environment applicable to healthcare practitioners, the  more...

Chemical Control for Food Manufacturers Ingredient Cleaning and Hazardous Materials - Webinar By GlobalCompliancePanel ...Why you should attend: Recalls for chemical contamination can be costly to an organization injuring consumers and damaging the brand and its sales. Hundreds of opportunities for accidental and intentional contamination can occur in even the best operations. Proper chemical control can minimize risk, resulting in better risk ratings and greater customer confidence. While regulatory and audit  more...

Using Foreign Trial Data in Your NDA Approval Process - Webinar By GlobalCompliancePanel ...ata. This webinar explores these requirements and how you can ensure compliance. Areas Covered In the Seminar: * Guidances and regulations that govern the FDA's acceptance of foreign trial data as pivotal data for NDA approval * What you can do to ensure compliance * Design considerations and requirements for foreign trials * Identify which guidances and regulations  more...

Complying with HIPAA Security Rules Whats in the rules and how you can most easily prepare for compliance - Webinar By GlobalCom ...t also in less obvious places such as copiers, printers, scanners, cell phones, and portable data devices. Why you should attend: The HIPAA Security Rule, in place and as proposed in amendments going into effect in 2011, calls for all Covered Entities and Business Associates, and their subcontractors, to be in compliance with provisions protecting all kinds of electronic protected health  more...

Water System Biofilm Control and Microbial Monitoring Myths - Webinar By GlobalCompliancePanel ...y, useless, and scientifically unjustifiable testing that can be stopped. You probably cannot afford to miss this important webinar! Areas Covered in the Session: * Why water myths develop o Impact of c-GMPs o Well-meaning but misguided precedents o Scientifically unchallenged traditions and benchmarking o Rule-hungry culture * Water  more...

Internal Audits Maintaining your Quality Systems at the Ready - Webinar By GlobalCompliancePanel ...udit 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 confidence in the companya ™s  more...

Operational Risk Management Ensuring Safety for Food Systems - Webinar By GlobalCompliancePanel ...ing risk levels prior to problems that may lead to significant setbacks. The procedures covered are mathematically sound, simple to implement and can be implemented as a result of attention from any level in the operation. Generally, personnel in any operation can be employed in the risk reduction planning and implementation efforts. The session will also provide information regarding how to  more...

Design History File DHF Device Master Record DMR Device History Record DHR and Technical File TF - Regulatory Documents Explaine ...ur device? Is your DMR accurate and is it being followed? Can the operators access your DMR? Are you recording and documenting all your production and testing data and maintaining them in the DHR? Areas Covered in the Session: * FDA Quality Systems Regulation Requirements/ Definitions * MDD Requirements/ Definitions * Design History File (DHF) o Definition  more...

New Changes to HIPAA The latest changes in the regulations and what they mean to you - Webinar By GlobalCompliancePanel ...y 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 affected in the new law, including new requirements for restricting and accounting of disclosures and increased enforcement  more...

Key Concepts in Successful Water System Sanitization - Webinar By GlobalCompliancePanel ...success. This presentation focuses on the factors that can lead to water system sanitization success as well as failure so that the user can not only devise workable sanitization approaches, but also be able to recognize the early symptoms of a sanitization failure and troubleshoot the process for better optimization. Areas Covered in the Session: * Understand the basic water  more...

Japan - Regulatory Filing Requirements and Compliance Processes for Life Sciences - Part I and Part II - Webinar By GlobalCompli ...tory agencies. The course will also discuss how personnel can best address the conflicts that sometimes arise and the approach that can best be taken for resolution. Agenda for Part I: Japan - Understanding the Dynamics of the Changing Structure, Regulatory Requirements and Compliance Processes for Life Science Products * Japan's Regulatory Structure for the Life Science Product  more...

FDA 483 Observations in the Laboratory What went wrong How can they be avoided - Webinar By GlobalCompliancePanel ...atories. Why you should attend: An FDA 483 observation can have an impact on any unit within a firm and laboratories have received more than their share. Since the early 1990s, the investigators have focused on challenges to the firms' laboratory control system. Laboratories should proactively address issues of concern to the regulators. In this webinar we will review and discuss FDA 483  more...

The Advantages of Linking Management Systems - Webinar by GlobalCompliancePanel Overview: It's important to improve the dialogue between financial, quality, IT and environmental management systems. Members of these management systems need to understand what the others do. Quality and environmental managers need to understand the language of finance and the effect of operations on the bottom line, while financial managers need to know how quality, environmental and IT  more...

Basics of OTC Drug Labeling Compliance - Webinar By GlobalCompliancePanel Overview: The webinar will help participants review and understand FDA requirements for OTC Drug labeling and compliance. OTC Monographs and their importance to OTC Drug marketing in the U. S. will also be covered. Why should you attend: Anyone who wants to market OTC drugs in the U. S.A. and assure that they're labeled properly with appropriate claims will benefit from this program/ webinar.  more...

Introduction to Operational Risk - Webinar By GlobalCompliancePanel ...orks and standards in use today and simple techniques you can apply to reduce both legal risk and the risk of financial crimes, and guidelines to institute a systematic approach to operational risk. Areas Covered In the Seminar: After attending this session, you will be able to: PART ONE * Identify the major categories of Risk according to Basel * List the seven major  more...

Know Your Customer - The DEA Due Diligence - Webinar By GlobalComplaincePanel This training will cover several recommendations to improve Due Diligence when distributing Schedules II through V controlled substances and regulated chemicals to your customers and what steps can be taken to prevent the illicit use or diversion of any product sold to a customer. As a firm handling these products, you will get a better understanding of what is required from a DEA registered  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...

Validation and Use of Excel Spreadsheets in FDA Regulated Environments - Webinar by GlobalCompliancePanel Excel Applications are widely used in laboratories, offices and manufacturing e. g., for data capture, data manipulation and report generation. Regulations such as HIPAA, Sarbanes Oxley Act and FDA's GxP and 21 CFR Part 11 require users of software and computer systems to demonstrate and document data accuracy, integrity and confidentiality. Out-of-the box Excel has not been designed for  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 ...mpany manages the crisis situations it will make a significant difference in how your company brand is perceived in the public's eyes and how well it succeeds in today's highly competitive marketplace. Most important is that failure to ensure food safety can jeopardize the health of your customers and could be detrimental to your business and reputation. In current economic situation, most of  more...

Transfer of Analytical Methods FDA Expectations and Tools for Implementation - Webinar by GlobalCompliancePanel ...lytical 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 Health Canada. This webinar discusses how to execute meaningful Method Transfers of company methods by selecting appropriate analytical  more...

Auditing API Manufacturers and Suppliers - Webinar by GlobalCompliancePanel This program will focus on the basics needed to perform an API audit. Performing an audit is not simply an act of visiting a firm and checking off a list of questions. Auditing API producers and suppliers is an important part of GMP compliance programs. Identifying what approach or process to use is examined and the tools to utilize during an audit is also discussed. Audits at best are  more...

FDAs Update on Medical Device Labeling Changes - Webinar by GlobalCompliancePanel ...e regarding the parameters in which a device manufacturer can modify label changes to a product. Specifically, manufacturers can add or strengthen the contraindications, warnings, precautions or adverse reactions sections of labeling via a PMA supplement without prior FDA approval only when such modifications are based on newly acquired information and evidence of a causal association  more...

ICH Q7 Guidelines and Practical Approaches to Manufacturing APIs - Webinar by GlobalCompliancePanel ...opted Guidance will be surveyed and discussed, as only it can be by this actual author of the approved guidance. There are many consultants and "experts" that teach this subject, but almost none have first-hand knowledge of its development. Some of the behind the scenes background will be discussed so that participants will be able to better understand the true intent of the expert work  more...

Supplier Evaluation and Assessment How to Meet FDA QSR and ISO 13485 Requirements in a Cost-Effective Manner - Webinar by Global 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 supplier  more...

The ICF Process Tips on Achieving Optimal compliance and Comprehension - Webinar by GlobalCompliancePanel The ICF process, which involves communication between a consentee (patient/ subject) and a consenter (staff clinician/ designee), is a vital component to the authorization of any medical intervention or clinical research trial. IRBs, sponsors and clinical sites all share the responsibility of ensuring an adequate ICF process. Any inadequate ICF training to clinical sites and /or unclear  more...

Combination Products FDAs Proposed Rule for GMP Requirements and Introduction and Expectations for Combo Products - Webinar by G ...? How are combination products assigned for review? Where can I find guidance for how master files can be used in the submission of information relevant to my combination product Determine which Center will review my combination or non-combination product? These topics and more will be addressed during this Webinar, including recently FDA's proposed rule to codify the current good  more...

Document Approval Control and Distribution How to Meet FDA QSR and ISO 13485 Requirements in a Cost Effective Manner - Webinar b ...can be a time- and paper-consuming process. Even the simplest of changes often requires an inordinate amount of time spent in the preparation, submission, distribution, and implementation of change requests, document modifications, document review meetings, document approvals, and document placement. Many companies can spend MUCH LESS time and prepare MANY LESS documents, and still be in  more...

Defining and Managing Protocol DeviationViolationException - Webinar by GlobalCompliancePanel ...lpful for investigators and study sponsors, as these data can be used to determine the need for amendments to the protocol and/ or the related documents. The monitoring of the frequency and nature of PNF can also be used as a quality assurance measure for the site. A noncompliance with the study protocol should be reported as soon as it is identified. This is consistent with Good Clinical  more...

Project Management for FDA-Regulated Companies - Webinar by GlobalCompliancePanel This webinar will provide valuable guidance to regulated companies in development and implementation 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  more...

How to Survive a DEA Audit or FINDFINE - Webinar by GlobalCompliancePanel This training entitled "How to Survive a DEA Audi or FIND=FINE" will cover all the record-keeping and security requirements that a DEA registered pharmacy must comply with when handling controlled substances and regulated chemicals. It covers all elements of what occurs during an unannounced DEA Diversion inspection and the auditing of all controlled substances and regulated chemicals. Why  more...

Preparing for and Surviving an FDA Inspection - Webinar by GlobalCompliancePanel ...However, the arrival of an investigator for an inspection can still be an intimidating experience. The inspection can be less traumatic if the site and its personnel are properly prepared for the inspection and the investigator. During this hour presentation, you will find out how to prepare for the inspection and minimize stress, disorder, and any misinterpretation by the investigator during  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...

Signal Detection and Data Mining - Webinar by GlobalCompliancePanel ...cover the fundamentals of signal detection, and how these can be augmented by the use of data mining techniques. In March 2005, the FDA published final guidance on "Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment." This guidance defines the FDA's views on pharmacovigilance concepts, safety signal identification, pharmacoepidemiologic assessment and interpretation of  more...

Verification of Pharmacopeia Methods - Webinar by GlobalCompliancePanel ...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 Health Canada. This webinar explains the reason and purpose of USP chapter and helps you to interpret what is required for verification of  more...

Effective Essential CAPA process to avoid FDA 483 - Webinar by GlobalCompliancePanel ...gin by defining risk in compliance and the methods, which can be used to mitigate risk. One of the methods defined by the regulators and the industry is "Corrective Action / Preventive Action" otherwise referred to CA/ PA. We will first define what we mean by risk. We will then explore the factors associated with risk in compliance. We will also explore risk causing events and how to address  more...

Regulatory Requirements for Medical Device Calibration Programs - Webinar by GlobalCompliancePanel Calibration is an essential component of every Quality Management System (QMS). An effective system includes more than just management of stickers on equipment. This presentation will give you the background need to understand the requirements and effectively implement. The presentation states with the regulatory requirements in the FDAa ™s QSR, ISO 13485, and ISO 9001. After analysis of  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...

Defining Architecting and Managing Risk Assessments - Complinace Webinar by GlobalCompliancePanel ...ey are evolving, the mitigation steps to manage its risks can never be in lockstep with prevailing circumstances or conditions. Concise Risk Assessments are a vital component of any successful Risk based initiative. Intelligent enquiry is an art that is often little understood. How Risk Assessments are created, distributed, collated and analyzed can be the difference between risks detected  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...

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...

Oracle Financial R12 Oracle Supply Chain R12 SOA 11g Training Oracle Financial R12 / Oracle Supply 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  more...

Oracle Financial R12 OBIEE 11g SOA 11g Training Oracle Financial R12 / OBIEE 11g / SOA 11g Training We are glad to announce our New Batch on Oracle Financial R12 / OBIEE 11g / 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 - 10 Week End, 80 Hrs Training SOA Suite 11g : Demo on March 12  more...