Control Web-based Seminars

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

ITIL v3 Release Control and Validation Capability RCV ...vice Lifecycle and processes associated with the Release, Control and Validation of services and service delivery. The main focus of this course is on the operational-level process activities and supporting methods and approaches to executing these processes in a practical, hands-on learning environment. This training is intended to enable the holders of the certificate to apply the practices  more...

ITIL v3 Service Transition Lifecycle Course This 3-day course immerses learners in the overall concepts, processes, policies and methods associated with the Service Transition phase of the Service Lifecycle. The course covers the management and control of the activities and techniques within the Service Transition stage, but not the detail of each of the supporting processes. This course is designed using an engaging scenario-based approach  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...

Introduction to Visual Basic 2008 Training ...riables, and operators, along with all the important flow control structures. You ' ll work through several examples demonstrating the power of the .NET 3.5 Framework, and dig into creating and consuming your own classes and objects. The course moves on to working with data structures, such as arrays and collection classes, before finishing up with discussions of generics, handling exceptions  more...

Introduction to Spring Training ...o 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 instantiating, configuring, and assembling Spring beans for various purposes. The Core  more...

Advanced Visual Basic for Applications (VBA) In this advanced Visual Basic for Applications (VBA) training course, you will learn more advanced features of VBA. Specifically, you will learn to use flow control, work with the Office Assistant, create custom dialogs, automate processes and handle errors. Each lesson begins with a general overview of a feature and then shows how that feature works in each of the Office applications.  more...

Spring-MVC Web Applications ...o 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, including every level of multi-tier distributed systems. Here we focus on the Core and  more...

Java Persistence with Spring ...o 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 systems. Here we focus on the Core and persistence modules, with a brief stop in the Web  more...

Time Management Training This team buiding training course teaches students the fundamentals of time management. Students will learn how to evaluate the use of time, identify goals and set priorities, develop an overall time management plan, discuss the Pareto principle, assign a price to time, conduct a time audit, and correctly identify and control poor time management personality types. Course activities also cover  more...

SharePoint Designer Training ...7. Students will learn how to create and apply templates, control layout and spacing, create and apply style sheets, and apply IDs and classes. They will also insert, modify, and arrange images, create links and navigation bars, and insert and format tables, to prepare a website for publishing. In addition, students will learn how to create dynamic components, work with multimedia files,  more...

MOC 8819 - Payables Management I in Microsoft Dynamics GP 10.0 ...djustments, prepayments, month-end closing, and cash flow control.A thorough understanding of these topics allows for capitalizing on vendor discount dates to reduce payable liabilities and easily select the right vouchers for payment by date, vendor, number, or custom query to control cash outlay. This Microsoft Dynamics GP class teaches how to use comprehensive reporting features that present  more...

MOC 8824 - Sales Order Processing in Microsoft Dynamics GP 10.0 ...soft Dynamics GP Sales Order Processing gives you precise control over the flow of sales documents by defined quality insurance steps throughout the sales transaction life cycle. Unique ship to addresses per line item allows you to enter multiple items on a single document and ship to multiple locations.This Dynamics course shows you how to eliminate unnecessary steps in the order process, set  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 8400 - FRx 6.7 Report Design Essentials II This advanced Microsoft FRx training class builds on the basic report design skills learned in MOC8399. Using Microsoft FRx you learn advanced report design including linking to external worksheet data, linking row formats, multi company consolidations, currency translation reporting and cash flow. A combination of instructor guided exercises and practice tutorials allow students to master their  more...

Comprehensive JSP Training ...hich support JSP expressions for JSP 1.x containers, flow control for procedural processing in JSPs, and resource access. The formatting and internationalization/localization actions, which standardize formatted numeric and date/time output as well as multi-language support. The SQL actions, which dramatically simplify access to relational data from a JSP. The XML actions,  more...

Java Swing Training ...g simple or complex interfaces with the most common Swing controls and classes -- including buttons, lists, combo boxes, checkboxes and radio buttons, text controls, trees, and tables -- controlling multiple windows and dialogs, using panes to manage related interfaces, implementing popup menus, and using data transfer packages for clipboard and drag-and-drop implementations. The first module  more...

Structured FrameMaker: Building Structured Applications In this Structured FrameMaker training class, students will learn to build structured applications, which control the import and export of XML/SGML in FrameMaker.  more...

Excel 2007: VBA Programming Training This VBA programming for Excel 2007 training course is designed to give experienced Excel users proficiency in creating procedures that run in response to specific events, working with control structures, developing user forms to accept or display data, validating the data entry in user forms, and debugging and handling errors in code.  more...

Financial Management Training This Basic Financial Management training course introduces students to the fundamentals of financial management. Students will become familiar with basic accounting concepts and terms, track business transactions, use universal accounting tools such as the general journal, general ledger, and trial balance. Course activities also cover the purpose of and how to use the four financial  more...

Introduction to C# 2008 Training ...riables, and operators, along with all the important flow control structures. You will work through several examples demonstrating the power of the .NET Framework 3.5, and dig into creating and consuming your own classes and objects. The course moves on to working with data structures, such as arrays and collection classes, before finishing up with discussions of generics, handling exceptions  more...

Access 2007: VBA Programming Training This VBA programming for Access 2007 training course is designed for experienced Access 2007 users who want to learn ActiveX Data Objects, control structures, and the basics of VBA programming.  more...

Publisher 2007 Training This Microsoft Publisher training class teaches the core features and functions of Microsoft Publisher 2007. Students will learn how to create and edit publications, arrange text and pictures, work with master pages, and create and format tables. They will also learn how to flow text across text boxes, create a facing-pages layout, export publications to PDF, and prepare publications for  more...

Project Management Training This Project Management training class teaches students project-management techniques, including managing time and costs. Students will identify the features and attributes of a project, the steps and variables of the project management process, the effects of environmental, socioeconomic and organizational structure issues, and the responsibilities of a project manager. Course activities also  more...

MOC 6434 - Automating Windows Server 2008 Administration with Windows PowerShell This Windows Server 2008 training class provides students with the knowledge and skills to utilize Windows PowerShell for administering and automating administration of Windows Server 2008. The class focuses on cmdlets, script structure and flow control, language syntax, and implementation details of scripting administrative tasks using COM, WMI, and .NET foundations.  more...

MOC 5928 - Managing Projects ...wledge and skills to initiate, plan, execute, monitor and control, and close enterprise projects by using the Microsoft Office Project Server 2007 enterprise tool.This is the second class in the Microsoft Office Project 2007 Official Curriculum series and covers the Microsoft Enterprise Project Management (EPM) Solution.This training class is intended for experienced project managers and  more...

MOC 5927 - Microsoft Office Project 2007, Managing Projects ...nts with the knowledge and skills to build, maintain, and control well-formed project plans.This is the first class in the Microsoft Office Project 2007 Official Curriculum series and serves as the entry point for other Microsoft Official Curriculum (MOC) courses covering Microsoft Office Project 2007 and the Microsoft Enterprise Project Management (EPM) 2007 Solution.This training class is  more...

SQL Server 2005 Integration Services (SSIS) Training This SSIS training course will enable technology professionals with little or no ETL experience and minimal exposure to SQL Server 2005 and Visual Studio 2005 to be comfortable and productive with the SSIS tools and technologies. In this course you will learn about the SQL Server Management Studio (SSMS) and building Database Maintenance Plans. You will be introduced to the Business Intelligence  more...

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

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

Understanding Improving Yields Scrap Rework Scrap and yield are different measurements that tell us different things about our production processes. Measuring and monitoring them precisely (and individually) is an important component of any process improvement initiative. If these values get comingled in the measurement procedures, underlying root cause analysis is certain to result. This FREE 1-hour webinar presents the CORRECT  more...

Better Methods for Maintaining Accurate Operation Standards ...e cornerstone of successful capacity planning, work order control, process flow planning and cost accounting. There are few data elements in a manufacturing company's database that require the attention that operation standards require. This LIVE and INTERACTIVE 90-minute workshop will present several ideas for better maintenance of these standards. The instructor will share methods that  more...

A Case for Routine Use of Statistical Process Control SPC in Manufacturing ...nt webinar, A Case for Routine Use of Statistical Process Control (SPC) in Manufacturing. Statistical Process Control is a term that describes a process for predicting failures and methodically determining the underlying cause(s) before the predicted failures can manifest into real failures. SPC represents a progressive set of predicted and predictive technical tools that any individual  more...

Demystifying the Calculations of Efficiency Utilization and Productivity You are invited to attend the Manufacturing Executive Institutea ™s November 2010 3rd Thursday - a Operations Improvement Series FREE webinar, Demystifying the Calculations of Efficiency, Utilization & Productivity. Given enough time, important terms always seem to morph and get used interchangeably. This is true with many daily terms we use in business. Worse, when important terms  more...

Better Methods for Calculating Safety Stock Service Levels This FREE 1-hour webinar addresses some techniques for reducing safety stock and still meeting target customer service levels. Specifically, this program will present some new ideas in safety stock and service level management by utilizing a unique modeling instrument that simulates safety stock, service levels, stock-outs and inventory investment from a random stream of demand over multiple  more...

Verification vs Validation in Regulated Industries - Webinar By GlobalCompliancePanel Overview: Attend this webinar to understand the differences and benefits of verification and validation. Learn about the risks and complications involved with the application of sound verification and validation principles. Thursday, March 1, 2012 10: 00 AM PST | 01: 00 PM EST  more...

Statistics in Quality Control - Critical decisions-Risks Basics - Webinar By GlobalCompliancePanel Statistical Applications includes topics related to basic statistical applications and advanced statistical applications such as statistical process controls (SPC). Includes elements of central tendency, dispersion, proportions and percentages, probability, capability, control limits, specifications limits and more. Thursday, January 12, 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...

Master Production Record Requirement - Webinar By GlobalCompliancePanel This program will address the 21CFR and Eudralex Volume 4 requirements and interpretation, as well as FDA Guidance regarding the creation, review and approval, and control of Master Production Records. Tuesday, December 20, 2011 10: 00 AM PST | 01: 00 PM EST  more...

Best Practices in Complaint Management - Webinar By GlobalCompliancePanel Negative customer feedback about a medical device's performance or safety is a strong indicator of whether a firm's manufacturing process is in control. This feedback is therefore subject to many requirements in both the QSR and ISO 13485. Failure to follow up on complaints about medical devices is among the most frequently cited observations on FDA-483s. Wednesday, November 2, 2011 10: 00  more...

Working with the Pharmacopeias and Compendia - Webinar By GlobalCompliancePanel ...that the pharmacopeias play in the regulation and quality control of pharmaceutical products. The pharmacopeias play a key role in setting standards for individual pharmaceutical products. These standards are both for the physico-chemical properties of pharmaceuticals and for the methods used in the testing of these products. While the pharmacopeias are important for setting standards for  more...

Audits In The Health Care Industry - Getting Ready for an Outside Audit - Webinar By mentorhealth You need to attend in order to control your own destiny. Get involved up front instead of being a "sitting duck". Tuesday, October 11, 2011 10: 00 AM PDT | 01: 00 PM EDT  more...

ITIL v3 Service Operation Virtual Instructor Led This five-day Live Instructor-Led online course provides you with an intense and focused exploration of the new and updated topics in ITIL ® v3 from the point of view of the owner of a process or set of activities. The course is intended for those who work within a Service Operation (SO) environment and require a deeper understanding of the underlying concepts, processes/ functions and  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...

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

Statistical Applications - Webinar By GlobalCompliancePanel Statistical Applications includes topics related to basic statistical applications and advanced statistical applications such as statistical process controls (SPC). Includes elements of central tendency, dispersion, proportions and percentages, probability, capability, control limits, specifications limits and more.  more...

SAP FICO Online Competency Development Training program ...ys: Define Base Method/ Define Multi level method/ Period control methods 29. Creation of main Asset master and sub asset master data/ Asset transactions 30. Depreciation run/ display of balances 31. Reports and Integrations 32. Financial statement versions/ Reports in G/ L accounting/ list of accounts/ List of journal entries 33. Reports in Accounts Payable / Accounts Receivable and Asset  more...

Establishing a Reduced Testing Program for Pharmaceutical Medical Device Components ...esting of incoming components provided there are adequate controls on specification control, material qualification, supplier qualification & monitoring, material validation, and collaborative testing. Industry practice in the performance of reduced testing has resulted in new and modified expectations and requirements. The benefits of systematic reduced testing program include increased  more...

How to Survive a DEA Inspection Series Only Manufacturers and Distributors - Webinar By GlobalCompliancePanel This training will cover DEA record-keeping and security requirements that a registrant must comply with when handling controlled substances and regulated chemicals. It covers elements of what occurs during unannounced DEA Diversion inspection and the auditing of all controlled substances and regulated chemicals. As a firm handling those products, you will get a better understanding of what is  more...

A Simpler Approach to Implementing or Validating CGMPs to 21 CFR 11 Electronic Records Signatures - Webinar By GlobalComplianceP ...ing documentation and cGMP compliance actions, and in the controlling, running and monitoring of medical product processes, whether they be in the pharmaceutical, medical device, biologics or dietary supplements industries. Software is being developed for routing, managing, approving and signing all manner of cGMP documentation, maintenance of "controlled documents" as well as their update and  more...

Requirements of validation and control of EO Sterilization - Webinar by global compliance panel Sterilization validation is a topic that results in many audit observations from the FDA and international regulatory bodies.  more...

Verification vs Validation in Regulated Industries - webinars by gcp Attend this webinar to understand the differences and benefits of verification and validation. Learn about the risks and complications involved with the application of sound verification and validation principles.  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...

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

Validating Radiation Sterilization for Medical Device Industries by gcp ...diation, and the validation requirements. Routine process control and monitoring will be reviewed along with requirements to maintain the process effectiveness. Why should you attend: Radiation sterilization validation is a topic that results in many audit observations from the FDA and international regulatory bodies. Proper understanding of the principles and requirements of the related  more...

Assessing Unemployment Insurance Cost Controls by Train HR This webinar discusses the purposes and methodologies of UI audits in assessing an organization's unemployment insurance controls and the use of UI audits in reducing the organization's UI risk exposure and lowering UI tax liabilities and costs. Critical areas of UI cost management are reviewed and effective cost control strategies are identified.  more...

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

How to Create Configure and Manage a Design Inputs - Design Outputs Traceability Matrix utilizing the principles of Lean Documen ...nt a challenge to almost all industries that apply design controls. Typically, these cause the creation and maintenance of duplicate information across various documents - a major source of errors. This webinar applies the Theory of Lean Documents and the corresponding Theory of Lean Configuration to avoiding these errors, while presenting a fresh new approach to these key and related  more...

Creation and management of a Controlled Document System for a Life Sciences manufacturing plant utilizing the principles of Lean ...Controlled documents are one of 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.  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...

Creation of DHFs DMRs and DHRs utilizing the principles of Lean Documents and Lean Configuration by GlobalCompliancePanel Design History Files (DHF), Device Master Records (DMR), and Device History Records (DHR) are key building blocks used in the design, development, manufacturing, and cGMP compliance for the Medical Device Industry. Too often, these 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 also  more...

Master Production Record Requirements - Webinar By GlobalCompliancePanel ...Guidance regarding the creation, review and approval, and control of Master Production Records. The material will enable attendees to establish a consistent approach to the design of MPR, including cover page content, instructions, processing requirements and limits, and signature expectations. (There will also be a note on Device Master Record.) In addition to learning what is meant by  more...

DHF DMR DHR Technical File and Design Dossier - Key Requirements and Future Directions - Webinar By GlobalCompliancePanel ...nt product design documentation. The cGMPs mandate Design Control and the Design History File (DHF). In order to sell globally, the EU's CE-marking documentation is a requirement - the Technical FiIe or Design Dossier. Currently they serve different purposes, support different goals, but the TF/ DD is moving in the direction of the DHF. And the DHF is adapting to some of the features of the  more...

Pharmaceutical and Medical Device Validation Guidances - Similarities and Differences - Webinar By GlobalCompliancePanel ...validation Who Will Benefit: * Quality, quality control, regulatory, engineering, and manufacturing and IT staff working in the FDA regulated industry in the development and manufacture of medical products. * Interdepartmental functions associated with scaling up and commercializing a new medical product * Regulatory Affairs * Companies manufacturing combination  more...

Develop and Execute the Company Software VV Program - Webinar By GlobalCompliancePanel ...ecome pervasive in medical devices themselves, and in the controlling, running and monitoring of medical product processes, whether they be in the pharmaceutical, medical device, biologics or dietary supplements industries. Software is being developed for medical imaging, and even though control of computer for individuals having disabilities restricting hand or eye movement / coordination. The  more...

FMEA and Risk Management for Medical Devices - Webinar By GlobalCompliancePanel Overview: This presentation will explain the various terms used in risk management and the importance of ISO 14971 & ISO 13485 in the managements of risks during the life cycle of medical devices starting with design and manufacture. FMEA (Failure Mode & Effects Analysis) is only a segment of Risk Management, but quite valuable for assessing Risk as part of Risk Management. Now that EN 1441  more...

Requirements of the Master Production Record - Webinar By GlobalCompliancePanel ...Guidance regarding the creation, review and approval, and control of Master Production Records. The material will enable attendees to establish a consistent approach to the design of MPR, including cover page content, instructions, processing requirements and limits, and signature expectations. (There will also be a note on Device Master Record.) In addition to learning what is meant by  more...

FDA Clinical Trial Auditing and the due diligence Companies should conduct as part of their monitoring program - Webinar By GCP ...ring 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 their current practices for identifying gaps and risks, particularly in relation to preparing for regulatory inspections. It will be  more...

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

Facilities Cleaning in Cleanrooms and Controlled Environments - Webinar By GlobalCompliancePanel ...alls, and regulatory action. Therefore it is important to control cleanroom cleaning processes and ensure best practices are followed. Areas Covered in the Session: * Learn about cleaning and what it accomplishes in the cleanroom. * Identify cleaning agents, tools, and equipment. * Discuss cleaning personnel training and qualification. * Identify the methods of  more...

Calibration and Qualification in Analytical Laboratories - Webinar By GlobalCompliancePanel ...ations (URS) for analytical equipment o Change control for analytical equipment o Qualification of equipment o Allocating Analytical Instruments to USP Categories * Allocating Analytical Instruments to USP Categories Areas Covered in the Session: * Operational lab equipment requirements for calibration and qualification * Most common  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 ...ing Master Records * Module 10 - Comparing Equipment Controls * Module 11 - Comparing Material and Incoming Controls * Module 12 - Comparing the Control of Processes * Module 12 - Packaging and Labeling Comparisons * Module 13 - Laboratory Controls and Device Evaluation * Module 14 - Holding, Distribution, & Returns * Module 15 - Problem Solving-Deviations,  more...

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

Controlled Substances and the Hospital Pharmacy - Webinar By GlobalCompliancePanel ...al's Due Diligence when dispensing Schedules II through V controlled substances in a hospital setting and what steps that can be taken to detect and prevent the illicit use or diversion of any controlled substance. Objectives of the Presentation: The following areas are covered: * DEA Office of Diversion Control: This section will familiarize you with the authority given to DEA  more...

Bringing Compliance To Design Control For Older Products - Webinar By GlobalCompliancePanel ...control after product release including: design change control, design validation, and the Design History File. The webinar is designed to help regulatory Affairs, Quality Engineers, and Design Engineers maintain released products within current regulatory requirements. As an attendee you will learn what the FDAs expectations for your released products are. You will also learn about the  more...

Developing the Risk Management Plan - Webinar By GlobalCompliancePanel ...ability Criteria * Planning for verification of risk control implementation and effectiveness * Documenting responsibilities for risk activities * Establishing risk review activities * Example of a risk management plan * Risk Management in various organizational structures Who will benefit: * Risk Managers * Project Managers * Quality Engineers  more...

Validating Rapid Microbiological Methods - Webinar By GlobalCompliancePanel Overview: Method validation is the process used to confirm that an analytical procedure employed for a specific test is reliable, reproducible and suitable for its intended purpose. All analytical methods need to be validated prior to their introduction into routine use, and this is especially true for novel technology platforms, such as rapid microbiological methods (RMMs). Because many RMM  more...

Design Control for Medical Devices - Webinar By GlobalCompliancePanel ...ust 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 recommendations for implementation of a compliant design control system. Also discussed will be design control  more...

Purchasing and Supplier Controls in the Medical Device Industry - Webinar By GlobalCompliancePanel ...anies can spend MUCH LESS time and money, and still be in control of their suppliers and in compliance with the regulations. This presentation will review the QSR and ISO requirements for supplier evaluation and assessment, and provide cost efficient, equally compliant options to many of the most common practices. Why you should attend: A lack of adequate control over purchases has resulted  more...

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

Project Management for Clinical Trials - Webinar By GlobalCompliancePanel ...nd contingency planning * Project Implementation and control o Identifying the possible causes of problems o Effective communication and how to manage stakeholders o Implementing project control and reporting systems * Project Review and Learning for clinical trials Who Will Benefit: * Clinical Project Managers * Clinical Research  more...

Change Control -- Your Companys GMP Weak Point - Webinar By GlobalCompliancePanel ...that this call for change 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  more...

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

Introduction to Contamination Control Master Plans - Webinar by GlobalCompliancePanel ...ation, implementation, and maintenance of a Contamination Control Master Plan. Key benefits of this seminar include: * Achieve satisfactory inspections more easily * Higher assurance of new medical product approvals * Minimize nonconformances * Reduce rates of batch rework and rejections * Avoid product recalls * Identify and control the key contamination  more...

Process Validation current industry practices and FDA Guidance Document Review - Webinar by GlobalCompliancePanel ...e, varied in the process. The notions of critical process control parameters and control limits are introduced and explored as tools for performing process validation. Why should you attend: Process validation is an important subject for the pharmaceutical quality or regulatory professional. Process validation can be difficult and can cause confusion due to different standards, approaches,  more...

Food Safety Management Systems - ISO 220002005 - Webinar By GlobalCompliancePanel ...ion of Safe Products a flow diagrams, process steps and control measures * Hazard Assessment - Control Measures * Design and Redesign of HACCP Plan a Critical control points * Verification * Corrections and Corrective Actions * Handling of Potentially Unsafe Products * Recalls * Verification, Validation and Improvement of Food Safety Management Systems  more...

Controlled Substances and the Pharmacist - Webinar By GlobalCompliancePanel ...nt Administration (DEA) through their Office of Diversion Control (Diversion). Since the focus of any DEA investigation is the legitimacy of a prescription, the initial target is the pharmacist who fulfilled the prescription. The pharmacy may be inspected in order to determine their handling of controlled substances purchased and dispensed as a prescription. The inspection targets  more...

Medical Device Changes and The 510k - Webinar By GlobalCompliancePanel .../ changes proactively will further prove a company is "in control", and assist documenting the 510(k) submission (or 'not') rationale. Why should you attend: The FDA expects companies to perform meaningful, results driven 510(k) / change analysis activities. The company is held fully responsible for deciding when a new 510(k) filing is warranted. Growing high-profile field problems indicate  more...

Project Management in a cGMP Environment - Webinar By GlobalCompliancePanel ...to include regulatory requirements, design and/ or change control, with consideration of all applicable standards. The EU MDD and their notified bodies are no different. How can this be done from a project's inception? How can a Project Leader or Project Manager ensure critical elements are not omitted until late in the project when disaster looms? How to minimize scope creep? How to conclude a  more...

Legal Risks in Social Media for Healthcare Providers - Webinar By GlobalCompliancePanel ...ues * Advertising rules * Content ownership and control * Potential SEC issues relative to social media marketing * Company-sponsored blogs versus outsider forums * Dealing with on-line critics * Other defensive activities (monitoring your online presence) * Policies and procedures for corporate control Who Will Benefit: * Healthcare marketing  more...

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

Avoiding FDA 483 Observations by Identifying the Root Cause of Deviations - Webinar By GlobalCompliancePanel ...gation system will be integrated with the CAPA and Change Control Systems. Why you should attend: 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  more...

Water System Biofilm Control and Microbial Monitoring Myths - Webinar By GlobalCompliancePanel ...ter 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...

Internal Audits Maintaining your Quality Systems at the Ready - Webinar By GlobalCompliancePanel ...tunity for improvement in the food safety chain. Lack of control of parts and condition of equipment often contributes foreign material to the product resulting in costly product recoveries. Untimely repairs affect productivity as well as customer order fulfillment. A systematic approach to maintenance is critical to operations, quality and safety. Areas Covered in the Session: *  more...

Operational Risk Management Ensuring Safety for Food Systems - Webinar By GlobalCompliancePanel ...verview: 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 ...ed 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 cover each environment and present simple and effective strategies for satisfying the requirements.  more...

Designing and Implementing the Quality System for Combination Products - Webinar By GlobalCompliancePanel ...always understand how the systems operate and interact to control all the inputs that results in acceptable and superior products. Agenda Module 1: The role of the quality system & and regulatory loop Module 2: Key to success is management involvement, organizing, and training of all functions. Module 3: Management of Documentation and Records Module 4: Design Control Module 5:  more...

How to Prepare and Submit a Bullet Proof 510k and Latest FDA Proposed Changes to the Process - Webinar By GlobalCompliancePanel ...ubmission requirements under 21 CFR 807 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:  more...

Key Concepts in Successful Water System Sanitization - Webinar By GlobalCompliancePanel ... * Use this understanding to design effective microbial control measures for your water systems * Use this understanding to solve microbial problems originating from poor sanitization practices * Debunk a few water system myths related to sanitization Who Will Benefit: This webinar will be valuable for all companies that operate WFI or Purified Water systems, particularly for  more...

Preventive and Corrective Maintenance Protect your assets Protect your consumers - Webinar By GlobalCompliancePanel ...tunity for improvement in the food safety chain. Lack of control of parts and condition of equipment often contributes foreign material to the product resulting in costly product recoveries. Untimely repairs affect productivity as well as customer order fulfillment. A systematic approach to maintenance is critical to operations, quality and safety. Areas Covered in the Session: *  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 ...ators have focused on challenges to the firms' laboratory control system. Laboratories should proactively address issues of concern to the regulators. In this webinar we will review and discuss FDA 483 laboratory operation based observations, analyze the cause and propose measures to prevent similar observation on other laboratories. Areas Covered in the Session: * Regulations *  more...

101 cGMP To-Do List for 2011 - Webinar By GlobalCompliancePanel ...eak spots proactively will further prove a company is "in control", assist in timely review of submissions to the Agency, and in any remediation efforts. Why should you attend: Each year companies are to perform a complete review of their quality management system and its ability to meet the current GMP's. To add to the urgency, there has been a major shift in the emphasis of the U. S. FDA  more...

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

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

How to Prevent Food Safety Problems Using Your Current Quality System - Webinar by GlobalCompliancePanel ... 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 industries has long ago been rejected as a means of quality  more...

Medical Device Classification - Webinar by GlobalCompliancePanel ...nd III). The three risk levels require different types of control. The webinar explains the two dimensional sy 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  more...

Supplier Evaluation and Assessment How to Meet FDA QSR and ISO 13485 Requirements in a Cost-Effective Manner - Webinar by Global Supplier qualification and assessment is required in both the QSR regulations and ISO standards. Many companies spend a great deal of time and money in pursuit of compliance with this. Many companies can spend MUCH LESS time and money, and still be in control of their suppliers and in compliance with the regulations. This presentation will review the QSR and ISO requirements for supplier  more...

Statistical Concepts of Process Validation - Webinar by GlobalCompliancePanel ...pecification transferred from design. Statistical Process Control (SPC) is an important technique in the Performance Qualification (PQ) phase of validation. The presentation concludes by showing the strong relationship between validated processes and Risk Management. ISO 14971: 2007 requires that production (and post-production) information go back to Risk Assessment to help complete the life  more...

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

Preparing for and Surviving an FDA Inspection - Webinar by GlobalCompliancePanel ...mpany 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 arrival of an investigator for an inspection can still be an intimidating experience. The inspection can be less traumatic if the site and its personnel are properly prepared for the inspection and  more...

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

Outsourced processes and ISO 90012008 - Webinar by GlobalCompliancePanel ...tatutory 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 parent organization, such as a separate department or division. To help clarify the requirements, ISO issued a guidance document on Outsourced Processes. The  more...

Linkedin for online profile development Over 75 million professionals use LinkedIn to exchange information, ideas and opportunities * Stay informed about your contacts and industry * Find the people & knowledge you need to achieve your goals * Control your professional identity online Find past and present colleagues and classmates quickly. Discover inside connections when youa ™re looking for a job or new  more...

Key Modules of an Effective CAPA SOP - Webinar by GlobalCompliancePanel This webinar will examine the stated intent of the Agency to get tougher across the board in its expectations for the medical industry and its compliance to the cGMPs, especially CAPA. It will examine how these goals of the Agency have translated into action in the past half year, with trends evident in 483 observations and Warning Letters. A key to effective relations with the FDA is the emphasis  more...

A Guide for Compliance with Document Control Requirements for Food Manufacturers - Webinar by GlobalCompliancePanel An essential part of the Food and Site Security Plan and the Bioterrorism Act. of 2002 section 306. The control of food safety and quality records as required by customers, regulators and internal audit and legal disciplines.  more...

Change Control and Logging in the PCI environment - Webinar by GlobalCompliancePanel ...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 ...indicator of whether a firm's manufacturing process is in control. This feedback is therefore subject to many requirements in both the QSR and ISO 13485. Failure to follow up on complaints about medical devices is among the most frequently cited observations on FDA-483s. This session will include the requirements for defining, documenting, and implementing a complaint-handling system, including  more...

Leadership in Manufacturing Contamination Control ...he Microbiology Lab must take leadership in contamination control support for production because it is the hub of the necessary technical expertise. This broad manufacturing support role covers many areas, including routine raw material and product testing, disinfectant/ sanitant qualification, water and compressed gas testing, environmental monitoring, microbiological a awareness traininga  more...

Update on Unique Device Identifier for Device Manufacturers FDA is reconsidering whether some form of unique device identification (UDI) is warranted for medical devices, given the potential of UDI to help reduce medical errors, facilitate recalls, and other issues identified from above but also improve inventory control, improve reimbursement, and reduce product counterfeiting. Once your device is approved, ongoing regulatory requirements fall largely  more...

Foreign Material Control GlobalCompliancePanel brings a new webinar on the topic of Foreign Material Control. Webinar will be on March 9, 2010. Webinar will be presented by Melinda Allen. Ms. Allen is a Food Safety and Quality Consultant in the Food Industry. Melinda has had a long and dedicated career of Quality Assurance and Food Safety leadership with companies such as YUM Brands and Quiznos.  more...

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

Process Instrumentation and Control Online Certificate Course ...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...

Introduction to Professional Organizing - Webinar Discover what it takes to enter and succeed in this dynamic and growing industry. Individuals, families and companies, large and small, welcome assistance from Professional Organizers and as our industry matures, the need for more of us that instinctively know how to turn chaos into control increases dramatically. This webinar has been created to answer the many questions that must run  more...

Complete Java Training ...s Increment and Decrement Operators Cast Operator o Control Flow Statements Conditional Statements (if, if else, switch) while and do-while Loops & for Loops continue, break Statement o Exercises and Stand alone applications/ programs * Classes and Objects o Defining a Class o Creating an Object o Instance Data and Class Data o Methods o Constructors o Access  more...