System Web-based Seminars

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...

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

Documentum training Documentum Fundamentals Training which covers basics of Documentum including architecture ,object model and Documentum Query Language. Documentum Architecture Documentum Content Server i. e File System and Database. Documentum Client Applications like Webtop, Documentum Administrator Documentum Object Model Documentum Foundation Classes Documentum users and groups Documentum Administration  more...

Legal Word Processing Course - Microsoft Word 2007 This comprehensive course focuses on the core formatting elements of Microsoft Word 2003, 2007 or 2010. It provides conceptual and technical learning of the software's advanced features used by international law firm staff to process complex legal documents. The KAS Training Legal Word Processing course was developed by legal trainers with more than 20 years of experience in the legal industry.  more...

Spring Web Flow ...he Spring web framework, as underpinnings of the Web Flow system. Then we dive into Web Flow itself, and develop key concepts of flow, state, transition, and action. We get moderately complex applications up and running with these elements, and see how the JavaBeans used to power a flow can also take advantage of Spring configuration and dependency injection. Then we move into more  more...

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

MOC 8399 - FRx 6.7 Report Design Essentials I This Microsoft FRx training class covers the basic report design skills you need to create, maintain and distribute presentation quality reports using Microsoft FRx. The class also includes coverage of additional functionality designed to help you create new reports, and distribute and analyze your company ' s financial information. You learn about basic foundational skills, complex calculations,  more...

MOC 8811 - Foundation I in Microsoft Dynamics GP 10.0 This Microsoft Dynamics GP Foundation training class explores the basic elements of Microsoft Dynamics GP. Topics covered during this session include: system and company setup procedures, how to use reports and inquiries, how to use SmartList to expand inquiry and analysis capabilities, business alerts, process server and tips for the user to personalize shortcuts and checklists to streamline  more...

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

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 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...

MOC 2262 - Supporting Users Running Applications on a Microsoft Windows XP Operating System This Windows XP training class teaches students how to troubleshoot and repair problems with Windows XP by reacting to incident requests from end users. The class will help the student prepare for Exam 70-272: Supporting Users and Troubleshooting Desktop Applications on a Microsoft Windows XP Operating System.  more...

Java EE Seminar for Managers This course provides a coherent, high-level explanation of the Java Platform, Enterprise Edition (Java EE): what sorts of software are created with Java EE; how software is developed for this platform; 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  more...

SharePoint 2007 End User Training ...nts will learn how to fully utilize 2007 Microsoft Office system applications in your SharePoint 2007 environment. The SharePoint end user course will be walk you through all of the basic features of Windows SharePoint Services (WSS) and Microsoft Office SharePoint Server (MOSS) sites with many hands-on activities.This SharePoint 2007 course is designed for individuals who access information on  more...

Advanced ColdFusion Training: XML, External Data and File System This advanced ColdFusion class focuses on making the best use of several external data types including XML, Web Services, and more. You will also learn how to work with the file system to read, write, append and even upload files.  more...

Advanced Active Server Pages In this advanced ASP training course, students will learn to use sophisticated programming strategies and advanced features to add polish, speed and efficiency to Active Server Pages Web applications. In this ASP training course, students will work more thoroughly with ASP components for Web-to-database integration and use the server ' s file system to add features and functionality to a website.  more...

Introduction to Active Server Pages In this ASP training course, students will learn to build full-featured, database-driven Web sites. This introductory course for new programmers lays out the basics of server-side Web programming with an introduction to classic programming structures and good programming practices. Students will apply these programming skills to the development of a fully functional data-driven website with ASP  more...

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

MOC 6451 - Planning, Deploying and Managing Microsoft System Center Configuration Manager 2007 ...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 5119 - Supporting the Microsoft Windows Vista Operating System and Applications ...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 reinstallations.The Windows Vista class also provides  more...

MOC 5117 - Installing, Configuring, Troubleshooting, and Maintaining Windows Vista ...essionals who focus on a broad range of desktop operating system, desktop application, mobile device, networking, and hardware support issues. As working professionals, students must combine technical expertise, problem solving and decision-making skills, and a deep understanding of their business and technical environments to quickly resolve support issues. They consider all variables, justify  more...

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

MOC 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 2778 - Writing Queries Using Microsoft SQL Server 2008 Transact-SQL This Transact-SQL training class provides students with the technical skills required to write basic Transact-SQL queries for Microsoft SQL Server 2008.This Transact-SQL class is intended for SQL Server database administrators, implementers, system engineers, and developers who are responsible for writing queries.  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...

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...

Integrative Activity Based Costing Leadership An Overview of Bottom Up Cost Accounting ...ed. 2. To demonstrate how any standard cost accounting system can be made to calculate allocations based on activities instead of labor dollars. 3. To provide executives with an overview of how ABCA can motivate all levels of employees to self-identify, self-prioritize and self-eliminate waste throughout their respective operations. Within this webinar, we will review high-level  more...

Early Intervention Field Trauma Training ...oth didactic and experiential. Emergency Site Management System will be reviewed. WHO WOULD BENEFIT FROM PARTICIPATION? This certificate will benefit first responders (e. g., fire/ rescue, emergency medical services, law enforcement, etc.) as well as mental health and health care professionals. Participants will: a Learn to respond immediately to the emotional component of natural or  more...

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

A Better Method for Cross Training Production Personnel You are invited to attend the Manufacturing Executive Institutea ™s August 2009 3rd Thursday - Operations Improvement Series FREE webinar, A Better Method for Cross-Training Production Personnel. Companies that take cross training of production personnel seriously report as much as a 30% fewer direct labor employees than exact peer companies. They also report faster cycle times, higher  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...

ISO 13485 as a Quality Management System for Medical Devices - Webinar GlobalCompliancePanel This presentation will help you to understand ISO 13485 and implement a successful quality management system, comparing it to ISO 9001 and FDA & European Union requirements. Thursday, February 16, 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...

Computer System Validation Step-by-Step - Webinar GlobalCompliancePanel This webinar will give a good understanding of FDA requirements for computer system validation and provide steps for cost-effective implementation. Thursday, January 26, 2012 10: 00 AM PST | 01: 00 PM EST  more...

Efficient Computer System Validation - 10 Easy Steps - GlobalCompliancePanel This webinar details all of the templates used to create validation documentation, usually saving two-thirds of the time and costs. Wednesday, February 1, 2012 10: 00 AM PST | 01: 00 PM EST  more...

Dental Digital Radiography - Better for the Patient and the Practice - Webinar By mentorhealth This webinar is for those wondering what digital radiography is, how it differs from film, how it works, and how it impacts the dental office. And for those unsure which system to purchase and how to incorporate it into Their practice? It is also for those who are using it and learn how to use it more effectively. Tuesday, December 20, 2011 10: 00 AM PST | 01: 00 PM EST  more...

Medical Coding for Dental Sleep Apnea Treatment - Webinar By mentorhealth This webinar will provide the information that dental practices need to be able to truly help their patients afford this life saving treatment. All areas of helping dental practices implement this profit boosting system will be discussed. Price List: Live : $195. 00 Corporate live : $695. 00 Recorded : $245. 00 webinars@mentorhealth. com Phone: 800-447-9407 Fax: 302-288-6884  more...

Efficient Computer System Validation - 10 Easy Steps - Webinar GlobalCompliancePanel This webinar details all of the templates used to create validation documentation, usually saving two-thirds of the time and costs. Tuesday, November 15, 2011 10: 00 AM PST | 01: 00 PM EST  more...

Job Evaluation Methods and Plans - Webinar By TrainHR Overview : In this program the speaker will review the purpose and types of Job Evaluation Plans, used to establish grade levels for a company's job classifications. Job Evaluation Plans such as Ranking, Paired Comparison, Whole Job Method, Hay Plan, Factor Comparison, GS Classification System, Single Factor, Limited Factor, and Competency based plans will be addressed. In addition, the factors  more...

Does your Equipment Program Meet Current Regulatory Expectation - Webinar By GlobalCompliancePanel This Interactive webinar will begin with an overview of the GMP/ GLP requirements for an Equipment system. The procedure for Equipment Qualification will be discussed. The system elements required to manage the maintenance and calibration of all equipment in the laboratory will be discussed. The documentation which is critical for GMP/ GLP compliance will be reviewed. Thursday, October 20, 2011  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...

Document Approval Control and Distribution How to Meet FDA QSR and ISO 13485 Requirements in a Cost Effective Manner - Webinar B This webinar will provide valuable assistance to all regulated companies, since a CAPA program is a requirement across the Medical Device, Diagnostic, Pharmaceutical, and Biologics fields.  more...

CAPA Failure Investigation and Root Cause Analysis to Meet FDA Expectations - Webinar By GlobalCompliancePanel Defined Failure Investigation and Root Cause Analysis is a major tool in product complaint, non-conformance, and OOS failure investigations, and hazard analysis / risk management and mitigation activities, the basic foundation of a viable CAPA system. Wednesday, November 16, 2011 10: 00 AM PDT | 01: 00 PM EDT  more...

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

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...

Master Validation Planning - Webinar By GlobalCompliancePanel A Validation Master Plan (VMP) is a critical part of a successful validation project. It documents the intended path to be taken for the validation of an entire organization, one or multiple plants, a single system or assembly line, or even a collection of similar equipment, to be qualified and eventually validated.  more...

A Simpler Approach to Implementing or Validating CGMPs to 21 CFR 11 Electronic Records Signatures - Webinar By GlobalComplianceP ...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 manufacturer is responsible to identify these requirements and implement them into an effective 21 CFR Part 11 CGMP software V&V process. Why you should attend: Software has become pervasive in  more...

Effective Hazard Analysis to meet FDA and ISO134852003 Risk Management Requirements - webinar by global compliance panel FDA-GMPs, known as Quality System Regulations (QSRs), and ISO 13485 require Risk Management as integral part of the development life cycle.  more...

Residual Risk and Risk based Verification Learn how define the residual risk of your device and how to streamline the verification process by employing a risk based approach.  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...

Good Deviation Practice what you need to know-BY GCP This course explores the deviation and CAPA processes and best practices for both. It shows how to avoid pitfalls and minimize regulatory scrutiny by having a robust deviation/ CAPA system and thorough investigations  more...

Device Master Record Device History Record BY GCP The FDA's Quality System Regulation (QSR) requires each device manufacturer to compile the specifications and procedures for a medical device.  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...

Root Cause Analysis and Documentation Requirements for CAPA - Webinar By GlobalCompliancePanel RCA is a popular topic and many companies realize its importance in correcting problems. However, there is still much confusion and many problems continue to recur. This webinar will use thoughtful discussion, humorous analogies and case studies to distinguish between the true root cause and other common imposters. Emphasis will be placed on realizing system interactions and cultural  more...

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

ISO 13485 as a Quality Management System for Medical Devices by GlobalCompliancePanel ...d ISO 13485 and implement a successful quality management system, comparing it to ISO 9001 and FDA & European Union requirements. ISO 13485: 2003 is a quality management system standard specially written for the medical device industry and is on the U S Food & Drug Administration (FDA) list of recognized consensus standards. Medical device firms certified to ISO 13485: 2003 will find  more...

Creation and configuration of a Equipment Facilities and Preventive Maintenance System utilizing the principles of Lean Document Proper preventive maintenance and management of process equipment, and facilities is the foundation for any manufacturing process, including many processes not typically thought of as manufacturing.  more...

Understanding and Implementing FDAs 21 CFR Part 11 - Webinar By GlobalCompliancePanel In 1997 the US FDA issued a regulation that provides criteria for acceptance by the FDA of electronic records, electronic signatures and handwritten signatures. The rule applies to all industry segments regulated by the FDA that includes Good Laboratory Practice (GLP), Good Clinical Practice (GCP) and current Good Manufacturing Practice (cGMP). Even though the rule is more than 10 years old  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...

Understanding good Closed Loop CAPA system - Webinar By GlobalCompliancePanel This webinar will present how organizations 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  more...

Vendor Qualification Auditing for FDA Computer System Compliance - Webinar By GlobalCompliancePanel This Vendor Qualification training will include sample forms and checklists which may be used by the participants, along with some initial training on the appropriate use of forms and checklists  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 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...

Designing a CAPA System that Meets and Exceeds Regulatory Requirements - Webinar By GlobalCompliancePanel ...system in any Quality system. Most of the warning letters written by the FDA in 2010 were CAPA relate. Avoiding FDA CAPA findings starts with the design of a robust CAPA SYSTEM. The webinar covers "Off-label statute" and the FDA's nonbinding off-label guidance as relates to re-prints, performance claims, and Promotion. Emphasis is placed on ethical, moral, and legal expectations from the  more...

Develop and Execute the Company Software VV Program - Webinar By GlobalCompliancePanel ...* In Production and Test Equipment and * The Quality System A manufacturer is responsible to identify these requirements and implement them into an effective software V&V process. Why Should You Attend: Software has become pervasive in medical devices themselves, and in the controlling, running and monitoring of medical product processes, whether they be in the pharmaceutical,  more...

Root Cause Analysis - The Heart of a Successful CAPA Program - Webinar By GlobalCompliancePanel ...? Use RCA to facilitate a closed-loop problem resolution system to reduce a fire fightinga and minimize compliance problems. Why Should You Attend: Expectations for meaningful, results driven root cause analysis that addresses and resolves underlying product problems are increasing among regulatory agencies world wide, with good reason. EU's ISO 14971 (Device Risk Management) and the  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...

Conducting Successful Product Complaint Investigations - Webinar By GlobalCompliancePanel ...plaint investigations. An effective complaint handling system is an extremely important part of any quality system. Manufacturers should understand that any complaint received on a product shall be evaluated and, if necessary, thoroughly investigated and analyzed, and corrective action shall be taken. The results of this evaluation should lead to a conclusion regarding whether the complaint  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 ...firm's device history records is compliant to the Quality System regulation, yet when the FDA comes calling, FDA 483 DHR cites are written and warning letters, seizures or worse ensue. Internal Audits show the production controls system compliant, yet again FDA writes the firm up. This webinar will review the production records regulations; with an emphasis on just what is it that FDA is  more...

Webinar on Cloud Computing SaaS - Webinar By GlobalCompliancePanel ... cloud computing and explain the benefits of using a SaaS system. We will detail the differences between a Conventional Implementation and a SaaS Implementation Methodology. A SaaS CRM system will be utilized as an example to discuss what drives SaaS system compliance and how requirements can be limited to Customer specific configurations. The scope of the validation effort will be explained  more...

Understanding Attribute Acceptance Sampling including Z14 and c0 Plans -- Webinar By GlobalCompliancePanel ... balance between risk and cost. The person who set up the system retired a few years ago and isna ™t available to help. You have also heard about some new methods called c=0 or zero based acceptance. * How do you know how much your inspection system costs? * Are you inspecting too much, and wasting money? * Are you inspecting too little and incurring risk? * Do your  more...

Requirements of the Master Production Record - Webinar By GlobalCompliancePanel ...ts 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 packaging for the API and finished commercial product. It is  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...

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

Understanding ISO 13485 vs ISO 9001 for Successful QMS in Medical Device Industries - Webinar By GlobalCompliancePanel ...system standard specially written for the medical device industry and is on the U S Food & Drug Administration (FDA) list of recognized consensus standards. Medical device firms certified to ISO 13485: 2003 will find themselves very closely compliant with FDA's Quality System Requirements under 21CFR 820. This presentation will help you to understand ISO 13485 and implement a successful  more...

The Pharmaceutical Quality System - Webinar By GlobalCompliancePanel ...ution of the standards, describe a Pharmaceutical Quality System and discuss the transition to the Pharmaceutical Quality System. Why you should attend: The US FDA, and regulatory agencies around the world, are actively promoting the concept of a Pharmaceutical Quality System. The concept of a Quality System was imposed on the medical device industry through the implementation of a  more...

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

Elements of the Lot Disposition Process - Webinar By GlobalCompliancePanel ...manufacturing sites to establish sound quality management system procedures for the disposition of intermediates, API, drug substances, medical devices, finished product, and in-house manufactured components. It will describe a well-defined Quality role, identify requirements for resources, and outline the expectations for documentation review. Additionally, the course will look at the  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...

Validating Rapid Microbiological Methods - Webinar By GlobalCompliancePanel ...h to the validation process to ensure that the entire RMM system is suitable for its intended use. This seminar will provide an overview of how to design a meaningful validation program in order to effectively demonstrate that the new RMM is suitable for its intended use and is equivalent to, or better than, the existing method you intend to replace. Topics will include the development of User  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...

The Investigation System Discovery Planning Root Cause Analysis CAPA - Webinar By GlobalCompliancePanel ... to establish a comprehensive and compliant investigation system. Why should you attend: Inadequate failure investigations continue to be a major GMP deficiency cited during routine and "for-cause" inspections conducted by the FDA. While the FDA recognizes that failures are a part of business, it expects comprehensive investigations of those failures, the application of scientific judgment  more...

Understanding the Calibration Curve - Webinar By GlobalCompliancePanel ... analytical data is working with a calibrated measurement system. However, few people really understand the principles and assumptions behind the calibration methods used for their instruments. As a result, we often make mistakes, generate poor quality data, or perform additional experiments that do not improve the quality of our data. This presentation will help to eliminate these problems.  more...

Design Control for Medical Devices - Webinar By GlobalCompliancePanel ...vice, or even a modified design for an existing device, a systematic process must be followed. This process must ensure that all requirements are met. A firm's design control process must meet all regulatory requirements, but at the same time not be so unwieldy as the present a barrier to timely market introduction. This webinar will cover the basics of design controls, and provide  more...

Process Validation for Medical Devices - Webinar By GlobalCompliancePanel ... the process validation requirements of the FDA's Quality System Regulation, ISO 13485 and the GHTF Validation guidance N99-10 while offering information on how to implement an effective validation program. The purpose of this course is to provide an introduction to the fundamentals of process validation, explaining how, when, where and why one should validate. Participants will learn how to  more...

How to use QSIT to Your Advantage - Webinar By GlobalCompliancePanel ...ll regulated companies have an in-depth knowledge of this system, to enable them to prepare for the inspection. Delving into each and every section of the QSIT, this webinar also includes straightforward, helpful methods for incorporating it into your companya ™s ongoing quality system. Why you should attend: If you don't know what the FDA inspector is going to look at when (s)he  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...

Best practices for conducting OOS investigations - Webinar By GlobalCompliancePanel ...e among the most frequently cited area. The Investigation system will therefore continue to receive close scrutiny during FDA inspections in the coming months and years. The large number of citations indicates that though the regulations in this area have not changed, they are either not well understood or that organizations face practical difficulties in complying with them. Areas Covered  more...

Does your Equipment Program meet current regulatory expectations - Webinar By GlobalCompliancePanel ...an overview of the GMP/ GLP requirements for an Equipment system. The procedure for Equipment Qualification will be discussed. The system elements required to manage the maintenance and calibration of all equipment in the laboratory will be discussed. The documentation which is critical for GMP/ GLP compliance will be reviewed. Why you should attend: The equipment Program is a critical  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...

Tougher US FDA cGMP Compliance Audits - When Youre Not Ready - Webinar by GlobalCompliancePanel ...ctions (and grandfathered product) by means of the 510(k) system. Business continues to "shoot itself in the foot", including once highly respected companies. All this affects the Agency's approach to audits and their expectations for companies. They also use GMP compliance audits to drive companies to do much of their work for them. There will be no return to the past. Rather than be caught  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...

Computer Basics Computer Fundamentals 1. Overview to Computers. 2. Computer Architecture. 3. Hardware & Software. 4. Managing your computer hardware 5. Adding hardware  more...

Asterisk telephony Infrastructure setup Design & build telephony infrastructure using Asterisk. Agenda: 1. Introduction to Telephony 2. Understanding IP telephony 3. Understanding traditional PBX and Soft PBX. 4. Overview to Asterisk & related products. 5. Installing AsteriskNOW 6. Installing Elastix 7. Adding basic components - extensions, trunk, outboundroute etc., 8. Working with Ring groups, VoiceMail & IVR. 9.  more...

Excel Spreadsheets and FDA Device Regulations - Webinar by GlobalCompliancePanel ... when you are using software in production or the quality system * The use of Excel tools to help ensure spreadsheets are built correctly * The FDAa ™s requirements and expectation for production and quality system software * The reason for Part 11 and some of the implications * The requirements of Part 11 for electronic records and the current guidance document Why  more...

Understanding the Technical Requirements of 21 CFR Part 11 - Webinar by GlobalCompliancePanel ...ues 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 requirements is paramount to avoiding the syndrome of "testing into compliance" later on. Often, the compliance status of a system can be impacted by varying interpretations of the  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...

Hazard Analysis vs FMECA Differences and Commonalities - Webinar By GlobalCompliancePanel ...trengths 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 appropriateness during the different product development phases will be discussed. Areas Covered in the  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...

Effective Training Practices for FDA Compliance - Webinar By GlobalCompliancePanel ...raining program. In addition, an overview of the training system, including types of training planning, will offer considerations to make GMP training more effective. Why you should attend: Regulatory agencies around the world require that training on good manufacturing practices (GMP) be conducted on a regular basis for those who are involved in producing pharmaceutical and biological  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...

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...

Operational Risk Management Ensuring Safety for Food Systems - Webinar By GlobalCompliancePanel ...ng further behind. * A sample supplier qualification system based on food safety risk predictors. * A model for retail driven risk reduction based on supplier typologies Who will benefit: * Food supply chain buyers (farms, wholesalers and distributors, retailers, packers, restaurants, and processors) and corporate executives need to be updated and on top of how they can take  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...

How to Prepare and Submit a Bullet Proof 510k and Latest FDA Proposed Changes to the Process - Webinar By GlobalCompliancePanel ... as well as design control requirements under the Quality System (QS) regulation. Under the QS regulation, all Class II and III devices and certain Class I devices are required to be designed in conformance to 21 CFR 820. 30 Design Controls. FDA provides guidance and this course will address key resources when making critical decisions. Objectives: * Know the differences between the  more...

Understanding and Preparing for FDAs New Part 11 Inspection Program - Webinar By GlobalCompliancePanel Overview: Within the next few weeks and months the FDA will conduct a series of Part 11 related inspections. Planned routine inspections will be extended to evaluate the companies' practices to ensure accuracy, integrity, authenticity and availability of electronic records, and the FDA plans additional 'for cause inspections'. Inspections are planned for US but also in foreign countries. The  more...

Key Concepts in Successful Water System Sanitization - Webinar By GlobalCompliancePanel ...system is designed and installed without some capability of sanitization, the system design features, materials of construction, sanitization approach, as well as the frequency of the sanitization process have everything to do with its success. This presentation focuses on the factors that can lead to water system sanitization success as well as failure so that the user can not only devise  more...

Statistical Sampling Plans for Audits - Webinar By GlobalCompliancePanel ...w: The purpose of auditing is to identify failures in the system or gross negligence. The real question, "how bad does the system need to be for auditing to work?" This talk will look at statistical distribution for rare events 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  more...

Recalls Removals and Market Corrections in Compliance with FDA and ISO Requirements - Webinar By GlobalCompliancePanel Overview: To satisfy QSR and ISO 13485 requirements, medical device companies must respond to field reports swiftly and compliantly. There are certain circumstances in which a report from the field requires the device manufacturer to take steps regarding product in the field. It is critical that the company take the required steps in the required timeframes. FDA and ISO requirements overlap to  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...

101 cGMP To-Do List for 2011 - Webinar By GlobalCompliancePanel ...al Management Review of their existing quality management system. Such a review takes on added urgency as a result of the stated intent of the Agency to get tougher across the board in its expectations for the medical industry and what it (the FDA and industry) need to do internally. A review of recent information from the Agency, other goals of the Agency that have already been translated  more...

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

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

ISO 13485 as a Quality Management System for Medical Devices - Webinar By GlobalCompliancePanel ...d ISO 13485 and implement a successful quality management system, comparing it to ISO 9001 and FDA & European Union requirements. ISO 13485: 2003 is a quality management system standard specially written for the medical device industry and is on the U S Food & Drug Administration (FDA) list of recognized consensus standards. Medical device firms certified to ISO 13485: 2003 will find  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...

Complaint Handling in Compliance with FDA and ISO Regulations - Webinar by GlobalCompliancePanel ...ining, documenting, and implementing a complaint-handling system, including the requirements for complaint review, investigation, and corrective action, as well as the ISO-specific implications. This session will discuss the best way to document customer feedback, what constitutes a complaint, and what do with "non-complaint" feedback. Also contained will be a suggested method on including  more...

Root Cause Analysis Shutting Down the Alligator Farm - Webinar by GlobalCompliancePanel RCA is a popular topic and many companies realize its importance in correcting problems. However, there is still much confusion and many problems continue to recur. This webinar will use thoughtful discussion, humorous analogies and case studies to distinguish between the true root cause and other common imposters. Emphasis will be placed on realizing system interactions and cultural  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...

Computer System Validation Step-by-Step - Webinar by GlobalCompliancePanel Learn computer system validation essentials and eight fundamental steps of implementation for cost saving. Get complementary SOPs and checklists for easy implementation. Understand the structure of validation plan, documentation of ongoing performance, structure of validation report.  more...

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

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

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

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

Medical Device Classification - Webinar by GlobalCompliancePanel ...The EUa ™s MDD classifies devices using a rule based system found in Annex IX of the MDD. Devices fall into four risk categories (I, IIa, IIb, and III). The risk class of the device determines the available conformity paths the manufacturer may use to affix the CE mark. This webinar explains the risk classification and conformity paths using the MDD version in effect after March 2010.  more...

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

Value-Adding Internal Auditing Learn how to get your Internal Audit System to promote improvements and add real value to your or Auditing is a critical function of a medical product company. It provides management with information about how effectively a company controls the quality of their processes and products. Auditors must perform their jobs competently to ensure their company's compliance with pharmaceutical GMP regulations and other quality standards. This course provides information to increase an auditor's  more...

Document Approval Control and Distribution How to Meet FDA QSR and ISO 13485 Requirements in a Cost Effective Manner - Webinar b Document control 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  more...

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

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

Outsourced processes and ISO 90012008 - Webinar by GlobalCompliancePanel ...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 requirements. The changes reinforce the need for control over outsourced processes and recommend using the methods found in the ISO 9001 Purchasing clause. These changes also include suppliers who are part of the same  more...

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

Effective Essential CAPA process to avoid FDA 483 - Webinar by GlobalCompliancePanel How do you prevent becoming another FDA statistic? Poor corrective and preventive action (CA/ PA) and investigations continue to be among top FDA Form 483 deficiencies issued to drug, biologic, and medical device manufacturers. It's in everyone's self interest to improve the quality of investigations and CA/ PA. This webinar will provide regulated companies the core principles and practices needed  more...

Regulatory Requirements for Medical Device Calibration Programs - Webinar by GlobalCompliancePanel ...ion 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 these  more...

Change Control and Logging in the PCI environment - Webinar by GlobalCompliancePanel Change control in IT environments has been a focus for a decade or so, especially for application changes. In this webinar you will learn: The components of a strong change management program, including specifics on configuration management, system hardening, and compliance review. In addition, the types of logging and monitoring required by the PCI DSS will be discussed which will enable  more...

Best Practices in Complaint Management - Compliance Webinar by GlobalCompliancePanel ...ining, documenting, and implementing a complaint-handling system, including the requirements for complaint review, investigation, and corrective action, as well as the ISO-specific implications. This session will discuss the best way to document customer feedback, what constitutes a complaint, and what do with "non-complaint" feedback. Also contained will be a suggested method on including  more...

Auditing a Process-based System - Compliance Training Seminar by GlobalCompliancePanel There are a number of reasons for someone to attend this webinar. First and foremost they will gain an understanding of the process approach. The process approach requires management to identify all processes of the QMS, their sequence and interaction. They must ensure the effectiveness of all processes and the availability of needed resources, and monitor, measure, analyze and improve them. They  more...

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

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

ISO 13485 2003 - A Straightforward Interpretation with Recommendations for Easy Implementation GlobalCompliancePanel brings a new webinar for the medical devices industry professionals. Webinar will be on March 25, 2010. Webinar will be presented by Jeff Kasoff. Development, implementation, and maintenance of an ISO 13485-compliant quality management system requires many resources and personnel to meet with success. ISO 13485 is a wordy standard, drafted by individuals for many of  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...

Design Planning and conducting Effective audits ...nar will be presented by Mark Roberts. Internal quality system audits should be viewed as an improvement tool. Too often due they have a negative connotation and are viewed as a necessary evil. Effective audits can comply with the regulations and also be a source of improvement. Proper planning, staffing, training, and implementation are some of the keys to an effective internal audit.  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...

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

Student Shelter In Computers EC-Council Academic Partner Offers Certified Ethical Hacker CEH Course ...ng Networks Module 04: Enumeration Module 05: System Hacking Module 06: Trojans and Backdoors Module 07: Viruses and Worms Module 08: Sniffers Module 09: Social Engineering Module 10: Denial of Service Module 11: Session Hijacking Module 12: Hijacking Webservers Module 13: Hacking Web Applications Module 14: SQL Injection  more...

Basic Java Training - Short term ...ds and constructors o Input and Output - Using System class and Scanner o Access modifiers and scopes - public, protected, default and private o Loops and conditional execution using if, while, do-while, for, switch, etc. o Advanced foreach loop of Java 5 o Non access modifiers - static, final and abstract * Understanding Inheritance,  more...

Maintenance Management Online Certificate Course The Online Certificate Program in Maintenance Management consists of three modules, which will help you evaluate your operation; plan, coordinate and schedule maintenance; and properly use preventive and predictive maintenance in your operation. The program is designed for all types of maintenance environments including refineries, chemical plants, factories, mines, large buildings, organizations  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...

Excel at Filing - On-Demand Webinar ...ft Excel ® can be used to create an electronic filing system including electronic filing practices; printing file inventory lists; searching and tracking files; networking an electronic filing system; setting passwords; navigating within an electronic filing system; and potential uses for an electronic filing system. Each of your clients will have to deal with paper ~ both at home and  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...

Siebel Installation and Administration SiebelTraining. org conducts a 2 day workshop, classroom as well as online, for individuals to install an entire Siebel CRM server from scratch. In addition, the training further gives them inputs for basic system administration tasks. Hands-on sessions makes sure the trainees are confident of doing these activities on their own.  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...

Complete Java Training ... * A computer with internet connectivity. * Operating system that supports Java 1. 5. 0 or later * Eclipse 3. 2 * My SQL 5. 0 ================================================ Java EE Introduction training * Java EE Overview * Java EE Architecture * MVC Architecture * The Virtual Machine and Runtime * Containers and Components * Three Tier Architecture *  more...