T3 Systems Web-based Seminars

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

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

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

Introduction to Spring Training This course enables the experienced Java developer to use the Spring application framework to manage objects in a lightweight " IoC " (inversion-of-control) container. Spring is a far-reaching framework that aims to facilitate all sorts of Java development, including every level of multi-tier distributed systems. Here we focus on the " Core " module of the framework, developing facility in  more...

Spring-MVC Web Applications This course enables the experienced Java developer to use the Spring application framework to manage objects in a lightweight " IoC " (inversion-of-control) container; to create simple and complex web applications; and to manage persistent objects using Spring ' s support for DAOs and transaction control. Spring is a far-reaching framework that aims to facilitate all sorts of Java development,  more...

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

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 This Groovy training course teaches experienced Java developers how to write programs in 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  more...

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

MOC 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 This Windows Server training class provides students with the knowledge and skills to manage accounts and resources in a Microsoft Windows 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  more...

MOC 2277 - Implementing, Managing, and Maintaining a Microsoft Windows Server 2003 Network Infrastructure: Network Services This Windows Server 2003 training class provides students with the knowledge and skills to implement, manage, and maintain a Microsoft Windows Server 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;  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 You are invited to attend the Manufacturing Executive Institutea ™s May 19th 2011 3rd Thursday - a Operations Improvement Series FREE webinar, How to Achieve & Maintain ERP Systems Master File Data Integrity. Contrary to the popular belief that modern, fully-integrated information systems provide executives with the tools to make more effective and efficient decisions, there is increasing  more...

A Better Method for Rationalizing Capital investmentsTools for Calculating REAL Investment Value It is an interesting observation that manufacturers continue to struggle with the best way to rationalize new investments in capital equipment. Interestingly enough, this struggle is often the result of failed cost accounting systems and methods. It is these systems that fail to provide accurate information that ultimately allow an investment to be appropriately modeled within the context of the  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 This Webinar will help health information professionals understand what they have to do, and when, and what to keep in mind as they move forward, in order to be prepared for compliance with the new regulations. It will provide a comprehensive look at the changes in the law and prepare attendees for the process of incorporating the changes into how they do business in their facilities. Areas  more...

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 The webinar will 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  more...

Pharmaceutical and Medical Device Good Manufacturing Practices - Similarities and Differences - Webinar By GlobalCompliancePanel This webinar will explore differences and similarities between these 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  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 TRAINING DETAILS: Course Duration: 80 hours Training + Actual project Case Studies + Assignments Training Materials: All attendees would receive a Assignment after each module, a Notes and study material for examples covered. Training Format: This course is delivered as a highly interactive session, with extensive live examples. This course is delivered in Online using Web and Audio  more...

Business Analyst Competency Development Program BUSINESS ANALYST Competency Development Program About Zarantech: Zaran Tech is a global IT training and consulting services company with one goal in mind a develop and deliver the highest quality consultants to our Clients and customer. As a consulting company, we help organizations to work smarter and grow faster. We consult with our clients to build effective organizations, innovate & grow,  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 This webinar will concentrate on making sure you have current human resources policies that are in compliance with applicable laws and convey the desired practices in your organization. Policy should be reviewed and updated periodically and through this webinar you can review your current policies, clarify policies for easier administration, and perhaps add new policies others to address new  more...

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 Overview: If you handle any electronic patient information, dona ™t miss this teleconference on compliance with the extensive requirements for policies and procedures in the HIPAA security regulation. Electronic patient information is everywhere; not only is electronic protected health information in the obvious places such as practice management systems and electronic medical records, but  more...

Information Security and Payment Card Rules Protecting Patient Payment Data and Complying with PCI - Webinar By GlobalCompliance 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 Overview: This session will present the background of the regulations that call for information security risk analysis and show how it fits in to an overall information security management process. The risk analysis process will be presented within the context of the overall risk prioritization and risk mitigation process, using an example. The Information Security Risk Analysis Process  more...

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

Internal 21CFR Part 11 Compliance Auditing of Computer Systems - Webinar By GlobalCompliancePanel verview: This webinar will provide valuable assistance 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.  more...

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

The Most Common Problems in FDA Software Validation Verification- Webinar By GlobalCompliancePanel Overview: This webinar will give valuable help to FDA regulated Pharmaceutical, Medical Device, Biotech, Diagnostics and Biological manufacturers. In August 2010, FDA made an announcement affecting virtually every drug, device and biologic firm marketing products in the U. S: "The Agency (FDA) will be conducting a series of inspections in an effort to evaluate industry's compliance and  more...

How to successfully create a Device History Record and keep FDA happy in the process - Webinar By GlobalCompliancePanel Overview: Many companies are confident that their record keeping for the 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  more...

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

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

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

Gowning Systems Used in Cleanrooms Controlled Environments - Webinar By GlobalCompliancePanel Overview: This live 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.  more...

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

Understanding ISO 13485 vs ISO 9001 for Successful QMS in Medical Device Industries - Webinar By GlobalCompliancePanel Overview: 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 themselves very closely compliant with FDA's Quality System Requirements under 21CFR 820. This presentation will help you to  more...

The Pharmaceutical Quality System - Webinar By GlobalCompliancePanel Overview: This webinar will discuss the evolution 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  more...

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

Elements of the Lot Disposition Process - Webinar By GlobalCompliancePanel Overview: This program will provide the content for pharmaceutical 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  more...

Validation of ExistingLegacy Computer Systems for FDAEU Compliance - Webinar By GlobalCompliancePanel Overview: When existing or legacy computer systems are used in FDA or equivalent international environments they should be validated, a process sometimes called retrospective validation. While the industry is very well familiar with the validation of new systems, there are many questions about existing or legacy systems. This web seminar will give a good understanding on the regulatory  more...

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

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

Efficient Computer System Validation - 10 Easy Steps - Webinar By GlobalCompliancePanel Overview: 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 documentation and ensures efficient implementation of new and upgraded computer systems. This experience will prepare you to perform a validation project. Areas Covered in the  more...

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

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

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

Preparing for Pre-approval Inspections - Webinar By GlobalCompliancePanel Overview: This interactive webinar begins with an overview of the FDA Inspection process. Preparation for the inspection in the months before, the immediate weeks before and on the day of the inspection will be discussed. The Inspection process will be reviewed followed by a detailed look at common focus area areas of Inspectors. Procedures to be followed after the inspection such as  more...

Does your Equipment Program meet current regulatory expectations - Webinar By GlobalCompliancePanel Overview: 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. Why you  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 Overview: There is a pervasive public perception that the FDA has been ineffective in protecting the public. Recent news events in foods, drugs, and devices seem to support this perception. The "tougher" FDA is determined to change that perception. Industry must be prepared to adapt, and recognize that such adaptation will actually work to their long-term benefit. This webinar will discuss and  more...

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

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

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

21 CFR Part 11 Complete Manual For Compliance Success - GlobalCompliancePanel Virtual Seminar - Webinar By GlobalCompliancePanel Overview: 21 CFR Part 11 is FDA regulation for electronic signatures and electronic records. It started by the Pharma - it is a good regulation for medical and Pharma companies but it is also a good guideline for other industries. Why Should You Attend: FDA inspectors are ever increasing the number of inspections where they include Part 11 as a part of the scope or THE scope of the inspection.  more...

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

Food Safety Management Systems - ISO 220002005 - Webinar By GlobalCompliancePanel Overview: This presentation will assist organizations within the food chain to understand the requirements to meet the international standard for Food Safety Management. Areas Covered in the Session: The following areas will be addressed: * Key terms and definitions * General Requirements * Documentation * Management Responsibility * Resource Management *  more...

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

Validating Excel and Word Applications Documents - Webinar By GlobalCompliancePanel Overview: Both the U. S. FDA and the EU's MDD require companies to be proactive in reducing risk while increasing user benefits. How does this translate to common software applications programs, e. g., MS-Excel and MS-Word, or similar. How can these be verified and validated? Company quality data must be more "science based". What V&V (verification and validation) planning steps are expected  more...

Preparing for GFSI and other Third Party Audits - Webinar By GlobalCompliancePanel Overview: Preparation and organization are the keys to a successful audit. This session will allow your team to anticipate the auditors needs and result in the facility's ability to achieve the maximum benefit and score from the audit. Why you should attend: More and more customers are requiring GFSI audits such as ISO 22000, BRC and SQF or accepting them in lieu of their own audits.  more...

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

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

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

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

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

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

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

Operational Risk Management Ensuring Safety for Food Systems - Webinar By GlobalCompliancePanel Overview: With today's movement into more and more serious controls over food safety and security, the liabilities associated with recalls and deaths are creating new approaches to determine and reduce the likelihood of risks associated with contaminated foods. Risk assessment involves determining where and what types of risks are involved throughout any food process, assigning quantitative  more...

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 Overview: The FDA generally defines combination products as a product composed of any combination of a drug and a device; a biological product and a device; a drug and a biological product; or a drug, device, and a biological product. Although there are differences between these quality systems, the quality principles embodied in the systems are the same. This course looks at these principles  more...

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

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

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

Statistical Sampling Plans for Audits - Webinar By GlobalCompliancePanel Overview: 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  more...

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

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

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

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

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 The FDA generally defines combination products as a product composed of any combination of a drug and a device; a biological product and a device; a drug and a biological product; or a drug, device, and a biological product. Although there are differences between these quality systems, the quality principles embodied in the systems are the same. This course looks at these principles and the  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 This interactive one-day seminar details how to reduce costs associated with implementing, using, and maintaining computer systems in regulated environments. Nearly every computerized system used in laboratory, clinical, manufacturing and the quality process has to be validated. Participants will learn the latest techniques for complying with 21 CFR Part 11 that greatly reduce software  more...

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 In August 2010, FDA made an announcement affecting virtually every drug, device and biologic firm marketing products in the U. S: "The Agency (FDA) will be conducting a series of inspections in an effort to evaluate industry's compliance and understanding of Part 11...The Agency intends to take appropriate action to enforce Part 11 requirements for issues raised during the inspections..."  more...

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

Preparing for and Surviving an FDA Inspection - Webinar by GlobalCompliancePanel 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. The key to a successful audit is being able to communicate how your quality systems assure this state of control. However, the  more...

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

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

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

Quality Systems Inspection Technique QSIT and How to use it to Your Advantage GlobalCompliancePanel 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 The online certificate program in Process Instrumentation and Control (I&C) consists of three modules covering the different phases of I&C from a nonmathematical and practical point of view. It includes basic concepts, engineering, and installation of control equipment. The attendees will learn about: 1. Basics of I&C, including different control functions, types of control loops, and  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 Every successful client relationship starts with a Needs Analysis during the Initial Consultation. This Webinar gives you the core knowledge 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  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 Complete Java & J2EE Online Training Course Details * Duration: 3 to 3. 5 months * Timing: Every alternate day in week day and both week ends. * This course is Free for new students for first 2 weeks. * Pricing: 990$ (Including taxes) (Saves you 300$). * We beet all our competitors prices. * Register now Complete Java & J2EE Training Course Details  more...