Systems Web-based Seminars

Health Information Technology Introduction ...menting electronic health records, electronic prescribing systems, and other health information technology systems will also benefit from our sessions to obtain basic knowledge to move forward in their project. Although there are no educational requirements for taking our workshops or courses, it is recommended that individuals either have healthcare experience and participate in electronic  more...

Health Information Technology Systems ...menting electronic health records, electronic prescribing systems, and other health information technology systems will also benefit from our sessions to obtain basic knowledge to move forward in their project. Although there are no educational requirements for taking our workshops or courses, it is recommended that individuals either have healthcare experience and participate in electronic  more...

Webinars Online, educational sessions, describing and demonstrating key techniques and approaches to the analysis of business process and systems. Topics covered will include (in different sessions): Business Process Modelling Notation (landscapes and workflows), Unified Modelling Language (primarily use case, activity and class mdoelling), Data Modelling (entity relationship and physical schema  more...

SOA BPEL Online Training ...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 the same language. And then we have a 'glue' that binds all these services together.  more...

Introduction to Spring Training ...elopment, including every level of multi-tier distributed systems. Here we focus on the " Core " module of the framework, developing facility in instantiating, configuring, and assembling Spring beans for various purposes. The Core module gives the developer declarative control over object creation and assembly; this is useful for any tier of any Java application. So is Spring ' s  more...

Spring-MVC Web Applications ...elopment, including every level of multi-tier distributed systems. Here we focus on the Core and Web/MVC modules, with a lighter (but by no means dismissive) touch on persistence through DAO and ORM modules. The Core module gives the developer declarative control over object creation and assembly; this is useful for any tier of any Java application. So is Spring ' s validation framework,  more...

Java Persistence with Spring ...elopment, including every level of multi-tier distributed systems. Here we focus on the Core and persistence modules, with a brief stop in the Web module to support hands-on exercises in Spring persistence for web applications. Spring supports a wide range of persitence technology: everything from raw JDBC to sophisticated object/relational mapping tools such as Hibernate and TopLink, and  more...

RoboHelp 8 Training In this RoboHelp 8 training class, students will learn to create their own HTML Help systems complete with topics, books, links, tables, forms, glossaries, frames, skins, templates, master pages, Cascading Style Sheets, Dynamic HTML effects, forms, frames and more.  more...

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

MOC 5051 - Monitoring and Troubleshooting Microsoft Exchange Server 2007 This Exchange Server 2007 training class teaches messaging specialists to monitor and troubleshoot an Exchange Server 2007 messaging system. Students will learn how to correlate client and server issues and resolve those issues. They will also learn how to monitor systems and create reports from the monitoring data.  more...

MOC 2275 - Maintaining a Microsoft Windows Server 2003 Environment This Windows Server class provides students with the knowledge and skills that are needed to effectively maintain server resources, monitor server performance, and safeguard data on a computer running one of the operating systems in the Microsoft Windows Server 2003 family.This training class is intended for individuals who are employed as or seeking employment as a systems administrator or  more...

MOC 2278 - Planning and Maintaining a Microsoft Windows Server 2003 Network Infrastructure This Windows Server training class provides students with the knowledge and skills necessary to plan and maintain a Windows Server 2003 network infrastructure.This training class is appropriate for individuals employed as or seeking a position as a systems engineer. The class is also appropriate for individuals currently supporting a competitive platform who want to enhance their job skills on  more...

MOC 2261 - Supporting Users Running the Microsoft Windows XP Operating System This Windows XP training class provides students with the knowledge and skills to troubleshoot and escalate or repair problems with Windows desktop operating systems by reacting to incident requests from end users. This class will provide the basic knowledge of system architecture and security needed to provide the students with the requisite skills required to support end users and adhere to  more...

Building Web Applications with Servlets, JDBC and JSP This practical, application-oriented Java training course teaches Java Servlets, JDBC and JSP and shows how to use it to develop simple to complex database-driven Web applications. It is intended for experienced Java (J2SE) programmers who want to build Web applications or J2EE components and systems.  more...

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

Groovy Training for Java Developers ...Groovy that simplify, enhance, and expand their existing systems. The course will be taught by Ken Kousen. Dr. Kousen is an instructor, consultant, and developer specializing in all areas of Java, XML, and, more recently, Groovy and Grails. Over the past decade, he has taught courses and made presentations on topics ranging from Spring to Hibernate to Ajax to web services. His credentials  more...

MOC 6451 - Planning, Deploying and Managing Microsoft System Center Configuration Manager 2007 ...s, 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 Systems Engineers with one to three years of experience supporting multiple desktop and server computers running Microsoft Windows in medium to large enterprise organizations, and who have a need to plan  more...

MOC 2279 - Planning, Implementing, and Maintaining a Microsoft Windows Server 2003 Active Directory Infrastructure This Active Directory training class includes self-paced and instructor-facilitated components. It provides students with the knowledge and skills to successfully plan, implement, and troubleshoot a Microsoft Windows Server 2003 Active Directory directory service infrastructure. The course focuses on a Windows Server 2003 directory service environment, including forest and domain structure, Domain  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...

MOC 2274 - Managing a Microsoft Windows Server 2003 Environment ...indows Server 2003 environment. The class is intended for systems administrator and systems engineer candidates who are responsible for managing accounts and resources. These tasks include managing user, computer, and group accounts; managing access to network resources; managing printers; managing an organizational unit in a network based on Active Directory directory service; and implementing  more...

MOC 2277 - Implementing, Managing, and Maintaining a Microsoft Windows Server 2003 Network Infrastructure: Network Services ...er 2003 network infrastructure. The class is intended for systems administrator and systems engineer candidates who are responsible for implementing, managing, and maintaining server networking technologies. These tasks include implementing routing; implementing, managing, and maintaining Dynamic Host Configuration Protocol (DHCP), Domain Name System (DNS), and Windows Internet Name Service  more...

MOC 2273 - Managing and Maintaining a Microsoft Windows Server 2003 Environment This Windows Server training class combines instructor-led training with additional e-Learning content to provide students with the knowledge and skills that are required to manage accounts and resources, maintain server resources, monitor server performance, and safeguard data in a Microsoft Windows Server 2003 environment. This is the first class in the Systems Administrator and Systems  more...

How to Achieve Maintain ERP Systems Master File Data Integrity ...vement 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 evidence that this promise has not been fully realized. The truth is, as information systems grow increasingly more  more...

A Better Method for Rationalizing Capital investmentsTools for Calculating REAL Investment Value ...is struggle is often the result of failed cost accounting systems and methods. It is these systems that fail to provide accurate information that ultimately allow an investment to be appropriately modeled within the context of the entire organization. We will present a perspective and the necessary mechanics to allow participants to (1) question their current methods for evaluating  more...

Standards of Trauma Care Attachments systems and context Develops understanding of the practical applications of trauma practice, research, and theory among individuals and communities affected by trauma. The course examines age, gender, race, culture, social class, systemic issues, community standards of care, and other factors that are important in designing and implementing programs to fit client needs with appropriate treatment. OBJECTIVES:  more...

New Final HIPAA Amendments New final rules for HIPAA Expand the Scope and Increase Responsibilities ...dit requests. The features that must be available in EHR systems and the questions to ask system vendors will be described. The processes for responding to requests for copies of electronic records and accountings of disclosures will be related to the regulations that require them. The role of business associates who maintain or support your EHR will be discussed, and the extension of the  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). Tuesday, February 14, 2012 10: 00 AM PST | 01: 00 PM EST  more...

Auditing Computer Systems for FDA and International Compliance - Webinar By GlobalCompliancePanel This webinar will give a good understanding of FDA and international expectations for auditing computer systems and provide steps for cost-effective implementation. Tuesday, March 13, 2012 10: 00 AM PST | 01: 00 PM EST  more...

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

Change Control Management From Design to Commercialization - Webinar By GlobalCompliancePanel There is a need to implement an adequate formal level of change control during engineering projects (referred to as an Engineering Change Control) after the approval of the equipment/ systems specifications in addition to the more formal change control after the qualification of these systems. Thursday, January 12, 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...

The Best Ways to Add Efficiency to Dental Business Office Systems - Webinar By mentorhealth This webinar will fill in the gaps and provide the know-how to add the much needed efficiency to those systems. With the current economy making profitability more difficult, attending this webinar will help provide the tips to be more profitable through greater efficiency. Price List: Live : $195. 00 Corporate live : $695. 00 Recorded : $245. 00 webinars@mentorhealth. com Phone:  more...

The Controls for Outsourcing Manufacturing and Testing - Webinar GlobalCompliancePanel ...begin with a brief review about the importance of quality systems and their role in maintaining the organization. Outsourcing will be defined and examples throughout the FDA regulated industry will be discussed. Of course, regulatory requirements will be discussed to include the FDA's current thinking about the required controls. Particular emphasis will be given on the importance of  more...

Pharmaceutical and Medical Device Good Manufacturing Practices - Similarities and Differences - Webinar By GlobalCompliancePanel ...ese GMPs as well as show how they relate to other quality systems, regional regulations, and guidance documents. Examples include ICH, GHTF, ISO particularly ISO 13485 as well as European quality requirements. The considerable use of graphical techniques will enhance this learning experience. Questions are strongly encouraged. Price List: Live : $245. 00 Corporate live : $995. 00 Recorded :  more...

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

Effective Internal Auditing-Making Quality Systems More Efficient for the Medical Products Industry - Webinar By GlobalComplianc The different types of internal audits and how they are approached will be discussed. The Internal Audit Lifecycle will be followed from beginning to end. It will be shown that. Internal audits are not simple exercises to determine compliance to some regulatory standards. Instead, the focus must be on auditing the company's quality system to determine if they are meeting their objectives and are  more...

Hybrid Quality Systems For Pharmaceuticals - Combining ICH Q7A Part 210-211 - Webinar By GlobalCompliancePanel The manufacture of drugs is controlled by ICH-Q7A and 21 CFR Part 210 & 211. Although these standards were written 24 years apart, they complement each other in many ways. Thursday, September 29, 2011 10: 00 AM PDT | 01: 00 PM EDT  more...

Implementing a Quality Systems-Based Approach to GCP Compliance - Webinar By GlobalCompliancePanel Ensuring GCP quality has often been approached from the perspective of reviewing as many documents as possible, looking for errors and following up on corrections or making "notes to file." In order to design, implement, and maintain GCP compliance in an effective manner, a Quality Systems Approach should be adopted.  more...

JAVA J2EE JEE Professional Role Based Training from Zaran Tech ... to fill in the gaps and put all the pieces together a Systems Analysts and programmers interested in expanding their role into new Technology. Here are some videos explaining how we conduct our training program, use Training Blogs and Google documents to communicate with our trainees and share the Assignments, Video Recordings, Training documents, Training materials for our training  more...

Business Analyst Competency Development Program ... to fill in the gaps and put all the pieces together a Systems Analysts and programmers interested in expanding their role into the business area. About the Trainer: a 10 Years of IT Business Analysis Experience, including experience consulting for the a Big Foura a Domain expertise across multiple business verticals including Finance, Health Care and E Commerce a  more...

FDAs final Medical Device Data System Rule FDA's promulgation of Electronic Medical Records, introduction of Meaningful Use and desire to automatically acquire medical device data for inclusion in electronic records has resulted in the development of Medical Device Data Systems.  more...

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

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...

Auditing and Administrating Human Resources Policies and Practices by TrainHR ...by covering employer rights, notify employees of recourse systems, clarify expectations, consequences and rewards, reduce misunderstandings, save time and convey desired culture and behavior. Why you should attend: Human Resources policy is an important communication tool which can In Human Resources and as a manager, you will find yourself referring to the policies on a frequent basis and  more...

Water System Design Start-Up and Validation - Webinar By GlobalCompliancePanel This webinar provides a thorough examination of water systems. We will explore the typical components used in water systems and how these components are combined to achieve intended water quality specifications  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...

HIPAA Security Policies and Procedures Making them useful and relevant as well as compliant - Webinar By GlobalCompliancePanel ...rmation in the obvious places such as practice management systems and electronic medical records, but 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  more...

Information Security and Payment Card Rules Protecting Patient Payment Data and Complying with PCI - Webinar By GlobalCompliance Overview: In this session, attendees will learn what the PCI DSS requires for protection and how the PCI DSS relates to the HIPAA Security Rule - there are substantial similarities, and being prepared for one helps you prepare for the other, as well as for other requirements, such as breach notification. We will discuss how the regulations and standards work and their legal basis, as well as  more...

Information Security Risk Analysis Meeting HIPAA Requirements and the Meaningful Use Objective - Webinar By GlobalCompliancePane ...ing interviewing staff knowledgeable about operations and systems to discover how information is retained and moved, and reveal the risks inherent in such storage and transmission. Interview content is organized as departmental stories that are successively refined into process descriptions, lists of information in place or in motion, diagrams of information flows, and lists of information  more...

Root Cause Analysis - The Heart of a Successful CAPA Program - Webinar By GlobalCompliancePanel ... integral part of CAPA, Validation and Quality Management Systems / cGMP planning, implementation and execution. Areas Covered In the Session: * Regulatory "Hot Buttons" * The 4 Basic Steps to Problem Solving * A Suggested Investigation Template * ID / Document the Problem * Investigation / Analysis Methodology - The 7 RCA "Tools" * Find the Solution(s) *  more...

Internal 21CFR Part 11 Compliance Auditing of Computer Systems - Webinar By GlobalCompliancePanel ...ce to all regulated companies that need to validate their systems, including companies in the Medical Device, Diagnostic, Pharmaceutical, and Biologics fields and associated vendors such as contract research, manufacturing, testing and systems. This presentation will describe a proven process for preparing a site for inspection of systems. Case studies will be used to illustrate how this  more...

Design History File DHF Device Master Record DMR Device History Record DHR and Technical File TF - Regulatory Documents Explaine ...ds 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 different records. Are you maintaining adequate DHF, DMR, DHR, and TF records? Do you  more...

The Most Common Problems in FDA Software Validation Verification- Webinar By GlobalCompliancePanel ...tware used in manufacturing, devices, design, and quality systems. FDA has cited numerous companies on software verification and validation issues in Warning Letters and inspectional observations. The presentation will address some common sense approach to this dilemma without going overboard; such as having V&V plans and processes that clearly define the completion criteria for a product or  more...

How to successfully create a Device History Record and keep FDA happy in the process - Webinar By GlobalCompliancePanel ...mpliance. * 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 letters * Determining best practice for the DHR audit * Be prepared by knowing how to conduct a MORE thorough record audit * FDA 483 point issuance prevention  more...

Webinar on Cloud Computing SaaS - Webinar By GlobalCompliancePanel ...affected by this price cut. Vendors can provide validated systems that can be configured by the client and the client can leverage the validation effort performed by the vendor, which will also provide a cost savings to the client. This webinar will dispel these fears and give you the confidence you need to maintain a validated cloud based system. Areas Covered in the Session: * The  more...

Best Practices for the Implementation and Use of Test Management Tools - Webinar By GlobalCompliancePanel ...cuments that are managed both electronically (in multiple systems) during development, review, approval and manually once the validation project is concluded. This practice lends itself to possible non-compliance due to human error, procedures not being properly followed and corruption of hard copy validation evidence. These issues are prompting life-science companies to search for ways to  more...

FDA Clinical Trial Auditing and the due diligence Companies should conduct as part of their monitoring program - Webinar By GCP ... requests regarding monitoring practices. Many monitoring systems lack components that ensure proper management of the research site. Monitoring systems should include specific components to ensure control of investigational product, data integrity, oversight of investigators as well as other areas. The components of a quality monitoring system will be presented so that participants can assess  more...

Gowning Systems Used in Cleanrooms Controlled Environments - Webinar By GlobalCompliancePanel ...ive webinar concentrates on identifying cleanroom garment systems, how they should be used, management of their supply, and control of human variables. Key benefits of this seminar include: * In-dept understanding of cleanroom garments and their use. * Reduce personnel-related environmental contamination issues. * Achieve satisfactory inspections more easily. * Minimize  more...

Calibration and Qualification in Analytical Laboratories - Webinar By GlobalCompliancePanel ...monstrate 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 time, it is a frequently cited deviation in FDA inspectional  more...

Understanding ISO 13485 vs ISO 9001 for Successful QMS in Medical Device Industries - Webinar By GlobalCompliancePanel ...d you attend: International interest in certified quality systems is increasing. A Many foreign countries are now requesting medical device firm's supply them proof of certification to ISO 13485: 2003. To apply a CE mark under the Medical Device Directive, 93/ 42/ EEC, certification to ISO 13485 is required in most cases. This presentation is an in-depth analysis of ISO 13485 with comparisons  more...

The Pharmaceutical Quality System - Webinar By GlobalCompliancePanel ...ality System is and how to transition from the compliance systems of today to the systems outlined in the various guidance's. It will require organizations to transition from a philosophy of test quality in and do not look beyond the words in the GMPs to a more proactive philosophy that is consistent with contemporary quality standards, such as ISO, and includes concepts such as building  more...

A Comparison of the Pharmaceutical and Medical Device Good Manufacturing Practices - A Study of Similarities and Differences - W ...an emphasis on compliance to an emphasis on quality 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  more...

Elements of the Lot Disposition Process - Webinar By GlobalCompliancePanel ...sistently and in compliance with sound quality management systems. Areas Covered in the Session: * Compilation of Completed Records * Quality Technical Agreements * QA review of production records * Laboratory Testing Results * Batch Production Record Review * Critical Utilities and Environmental Monitoring Data * Requirements for COA * Communication  more...

Validation of ExistingLegacy Computer Systems for FDAEU Compliance - Webinar By GlobalCompliancePanel ...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 requirements, and it will have recommendations  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...

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

Design Control for Medical Devices - Webinar By GlobalCompliancePanel ...s/ her mind that perhaps this deficiency extends to other systems as well. Areas Covered In the Seminar: * History of design control * Design planning * Design input/ output * Design reviews * Design documentation * Design transfer * In-process design control Who will benefit: This webinar will provide valuable assistance to all companies that perform  more...

Process Validation for Medical Devices - Webinar By GlobalCompliancePanel ...o learn how to maintain adequate validation documentation systems and perform equipment qualifications and process validations, and evaluate the need for re-validations. Why you should attend: The guideline on "General Principals of Process Validation" was issued in May, 1987, and since then, medical device companies have struggled with process validation. Regulators believe through careful  more...

Purchasing and Supplier Controls in the Medical Device Industry - Webinar By GlobalCompliancePanel ...evices. Most medical device manufacturers have acceptable systems in place to assure component quality. But what about supplier quality? Your company must have a procedure in place that describes the methods you use to evaluate potential suppliers, and set forth requirements that your suppliers must meet to be considered "approved." You must also have a system in place to routinely assess your  more...

Preparing for Pre-approval Inspections - Webinar By GlobalCompliancePanel .../ 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 * Overview of the pre-approval inspection  more...

Does your Equipment Program meet current regulatory expectations - Webinar By GlobalCompliancePanel ...ed In the Seminar: * FDA requirement for Equipment systems * Overview of GMP/ GLP requirements for equipment * IIQ/ OQ/ PQ of Equipment * Equipment database * Equipment SOPs * Equipment Calibration and maintenance * Review of equipment related citations in recent Warning Letters Who will benefit: This course is intended to provide training how to perform  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...

Change Control -- Your Companys GMP Weak Point - Webinar By GlobalCompliancePanel ...ange has on a company 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  more...

Redhat Linux Redhat Linux Administration Introduction to Unix Introduction to Redhat Linux Manage File Systems RPM Administration ( Package ) System Boot and Shutdown User and Security Administration Managing and Monitoring System Processes with CLI Tools and /proc System backups and Restores Network Administration  more...

Information Security - Overview ...ion 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 security.  more...

Excel Spreadsheets and FDA Device Regulations - Webinar by GlobalCompliancePanel ... + Electronic records + Closed systems + Open systems o Summary of requirements + Validation + System access + Audit trail + Other requirements o The guidance document + Enforcement discretion + Electronic records . . .  more...

Understanding the Technical Requirements of 21 CFR Part 11 - Webinar by GlobalCompliancePanel ...igher level of scrutiny of the compliance of computerized systems utilized for regulated activities. To avoid any regulatory observations on your automated systems, it is important to ensure that compliance is built into those system from inception. This requires a good understanding of the technical requirements of 21 CFR Part and how to implement them. Areas Covered in the Session:  more...

21 CFR Part 11 Complete Manual For Compliance Success - GlobalCompliancePanel Virtual Seminar - Webinar By GlobalCompliancePanel ...ronic records as more and more companies are implementing systems and technologies to support these activities. The number of warning letters is increasing proportionally and we as quality and other professionals utilizing the technology and systems to support our businesses are not ready - we are not ready to prepare and host FDA inspections when Part 11 is in scope, we are unsure how to best  more...

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

Food Safety Management Systems - ISO 220002005 - Webinar By GlobalCompliancePanel ...ion, Validation and Improvement of Food Safety Management Systems * Improvement * Automation of Management Systems for management of Food Safety. Who Will Benefit: * Presidents/ Vice Presidents/ CEOs * Top Managers * Quality, environmental, or health and safety managers interested in understanding requirements for the ISO 22000: 2005 Food Safety Management System  more...

Controlled Substances and the Pharmacist - Webinar By GlobalCompliancePanel ...* Identify DEA security requirements pertaining to: Alarm Systems; Pharmacy Security; Hiring of Employees; Proper Drug Disposal; Prevention of Thefts and Losses; and other security issues. * Review DEA requirements pertaining to the filling of controlled substance prescriptions. This includes electronic prescriptions, a 90-day supply of a Schedule II drug, and prescriptions written for  more...

Validating Excel and Word Applications Documents - Webinar By GlobalCompliancePanel ...Where does ISO 14971, ICH Q9, and similar risk management systems come in? This webinar will evaluate the climate that has resulted in this call for change, and flag areas for heightened compliance in V&V planning. It will focus on eliminating major systemic validation problems. It will assist the attendee to review their existing system in light of current and anticipated changes in regulatory  more...

Preparing for GFSI and other Third Party Audits - Webinar By GlobalCompliancePanel ...s and dollars to professional help with developing better systems rather than simply reviewing current programs, the supplier will be given the tools necessary to do its own preassessment and gap analysis. Audit results are as much a function of proper preparation as day to day operations. Find out what you need to know to achieve success. Areas Covered in the Session: * Description  more...

Why is CAPA so often cited in medical device inspections - Webinar By GlobalCompliancePanel ...ve 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 should be risk-based. The presentation will give an example of how to  more...

Avoiding FDA 483 Observations by Identifying the Root Cause of Deviations - Webinar By GlobalCompliancePanel ...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 deviations. Participants will obtain a  more...

Complying with HIPAA Security Rules Whats in the rules and how you can most easily prepare for compliance - Webinar By GlobalCom ...rmation in the obvious places such as practice management systems and electronic medical records, but 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  more...

Water System Biofilm Control and Microbial Monitoring Myths - Webinar By GlobalCompliancePanel ...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, we need to be aware of these myths and  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 ...eporting by manufacturers, but also is working to improve systems in FDA to evaluate the data being received. FDA is currently receiving reports in several different systems, but will be switching over to an electronic reporting system. The presentation will review FDAs improvements activities including the status of the electronic system and describe the upcoming requirements for manufacturer  more...

Internal Audits Maintaining your Quality Systems at the Ready - Webinar By GlobalCompliancePanel ...he companya ™s ability to assess and improve its own systems. Why you should attend: Maintenance is often found to present the greatest area of opportunity for improvement in the food safety chain. Lack of control of parts and condition of equipment often contributes foreign material to the product resulting in costly product recoveries. Untimely repairs affect productivity as well as  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...

Analytical Instrument and Equipment Qualification in Quality Laboratories - Webinar By GlobalCompliancePanel Overview: The analytical instruments and equipment used in GXP laboratories must be calibrated and qualified for use in regulated testing. This includes quality control labs attached to cGMP facilities, GLP labs supporting animal toxicology studies and GCP labs supporting clinical trials. Additionally, labs supporting EPA studies are also regulated. This seminar will review the regulations that  more...

Designing and Implementing the Quality System for Combination Products - Webinar By GlobalCompliancePanel .... Although there are differences between these quality systems, the quality principles embodied in the systems are the same. This course looks at these principles and the processes associated with each principal to design, implement, and maintain a combination system that surpasses compliance requirements. The seminar will focus primarily on the principles embodied in CFR Parts 210-211 and  more...

Design History File DHF Device Master Record DMR Device History Record DHR and Technical File TF - Regulatory Documents Explaine ...ds 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 different records. Are you maintaining adequate DHF, DMR, DHR, and TF records? Do you  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 ...esign effective microbial control measures for your water systems * Use this understanding to solve microbial problems originating from poor sanitization practices * Debunk a few water system myths related to sanitization Who Will Benefit: This webinar will be valuable for all companies that operate WFI or Purified Water systems, particularly for those in FDA, EMA, and AAMI  more...

Statistical Sampling Plans for Audits - Webinar By GlobalCompliancePanel ...nts to show that the sample size needs to larger when the systems are better. This is a paradox for most auditors who when a problem is discovered increase their sample size. Most auditing sampling plans are based on either the binomial or normal distribution, though rare events usually follow the Poisson distribution. This talk will show how the Poisson relates to the binomial and normal  more...

FDA 483 Observations in the Laboratory What went wrong How can they be avoided - Webinar By GlobalCompliancePanel ...latory 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 real issue and suggest actions to prevent similar observations in other laboratories. Why you should attend: An FDA 483 observation can have an impact on  more...

A Comparison of ICH Q-10 Quality System and the FDAs Quality Systems Approach QSA to the Pharmaceutical GMPs - Webinar By Global ... What are the objectives of ICH-Q10 and the FDA's Quality Systems Approach to Pharmaceutical Good Manufacturing Practices? * What are the similarities and differences between these guidance documents? * What are some Pro and Cons of the product lifecycle for pharmaceuticals * Is the Quality Systems Approach really "Compliance in Sheep's Clothing? * Who will win the GMP  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 Advantages of Linking Management Systems - Webinar by GlobalCompliancePanel ...tween 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 managers can help improve results. In the long run  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...

Full Day Virtual Seminar - Designing and Implementing the Quality System for Combination Products - by GlobalCompliancePanel .... Although there are differences between these quality systems, the quality principles embodied in the systems are the same. This course looks at these principles and the processes associated with each principal to design, implement, and maintain a combination system that surpasses compliance requirements. The seminar will focus primarily on the principles embodied in CFR Parts 210-211 and  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...

Full Day Virtual Seminar - Reduce Software Validation Costs and Pass the New 21 CFR Part 11 Inspections - Webinar by GlobalCompl ...ciated with implementing, using, and maintaining computer systems in regulated environments. Nearly every computerized system used in laboratory, clinical, manufacturing and the quality process has to be validated. Participants will learn the latest techniques for complying with 21 CFR Part 11 that greatly reduce software validation project time. Methods for decreasing resource requirements,  more...

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

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

The Most Common Problems in FDA Software Validation Verification - Webinar by GlobalCompliancePanel ...tware used in manufacturing, devices, design, and quality systems. FDA has cited numerous companies on software verification and validation issues in Warning Letters and inspectional observations. The presentation will address some common sense approach to this dilemma without going overboard; such as having V&V plans and processes that clearly define the completion criteria for a product or  more...

FDAs New Enforcement of 21 CFR Part 11 - Webinar by GlobalCompliancePanel ...ite 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 guidance is not applied any more.  more...

Preparing for and Surviving an FDA Inspection - Webinar by GlobalCompliancePanel ...ssful audit is being able to communicate how your quality systems assure this state of control. 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  more...

Regulatory Requirements for Medical Device Calibration Programs - Webinar by GlobalCompliancePanel ...e documents. The FDA issued the Medical Device Quality Systems Manual to help companies implement the Quality system Regulation. Chapter 7 discusses the role of calibration systems in the QMS and helps define the regulatory expectations. ISO 10012: 2003 Measurement management systems - Requirements for measurement processes and measuring equipment, a document in the ISO 9000 family,  more...

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

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

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

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

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

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

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

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

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

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

Online Building Science Series March - August 2010 If you are interested in learning about the fundamentals of building science and the energy efficiency industry, or becoming a certified Energy Auditor, this series of online courses is for you. Every other week starting in March 2010, our online series will support you in becoming a building performance professional from the comfort of your home or office. Each interactive course is presented in  more...

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

Process Instrumentation and Control Online Certificate Course ...els. 5. Concepts and implementation of alarm and trip systems. 6. Different types of computer-based control systems, including PLCs and DCSs, as well as basic requirements for good operator interface. 7. Documentation required for I&C for front-end engineering and detail design. 8. Requirements for a successful installation, instrument checkout and controller tuning. 9.  more...

Organize Any Garage In No Time Whether you are listening to this webinar to help others organize their garage or if you are determined to "win the war on clutter" in your own garage, I am confident that you will become empowered to do so. Here are some of the topics you will learn that will enable you or your clienta ™s to use the garage for the purpose it was intended--to park cars--and still store the additional things  more...

How to Conduct an Effective Initial Consultation - On-Demand Webinar ...ledge and skills to accurately assess and create relevant systems and solutions that truly enhance your clientsa ™ lives and environments and to create your customizable needs analysis forms. Certified Professional Organizer ® Debra Milne will teach you simple ways to provide your best service and advice during this crucial moment of client interaction. As a bonus, you will receive  more...

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

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...

Records Management 5 - Additional RM Program Components - On-Demand Webinar The last in the series of webinars dealing with Records and Information Management will look at the other program components that should be considered to develop an effective and efficient program. Topics covered include: vital records protection; choosing the right medium or mix of media for storing the records; scanning records; policies and procedures; privacy; placing records on hold for  more...

Records Management 3 - Retention Scheduling - On-Demand Webinar The third in the series of Records Management webinars covers retention schedules. Topics include what the schedule should include, how to gather the data, how to apply legislation and get approvals. Michael Oa ™Shea has been involved in Records and Information Management consulting for over 20 years. He is one of the most respected international experts in traditional and emerging forms  more...

Records Management 2 - Developing Classification Schemes that are Used - On-Demand Webinar This webinar describes what a classification scheme really is, what a corporate scheme should include, how to develop one to gain maximum buy-in and how to apply and maintain it to ensure continuing effectiveness. Michael Oa ™Shea has been involved in Records and Information Management consulting for over 20 years. He is one of the most respected international experts in traditional and  more...

Records Management 4 - Records Management Software - On-Demand Webinar This webinar is the 4th in the series and it examines how the use of the proper software can greatly enhance the programa ™s effectiveness and reduce a lot of the more tedious, time consuming tasks associated with managing information. It will also cover the range of software options and how to develop and manage the process for developing system requirements and choosing the right solution.  more...

Records Management 1 - Its A Lot More Than Filing - On-Demand Webinar Records Management is a critical function in all businesses no matter what size the organization is. The larger the company the more complex records management becomes. In this first webinar of the Records Management series, learn the basics about this profession. Start to understand the terminology and the key components such as classification schemes, retention schedules, and the management  more...

Complete Java Training ...xample * Message-Driven Beans o Overview of Messaging Systems o Messaging, Loose Coupling o Pub/ Sub, Point2Poin * JMS API o Overview and Structure o ConnectionFactory and Destination o JMS Producer and Consumer Client example o JMS Messages * Message-Driven Beans (MDB) o MDB Overview o MDB example * Session Facade * Entity Beans Overview General Frameworks  more...