S 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 This 5-day course immerses learners in the practical aspects of the ITIL ® v3 Service 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  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 In this Visual Basic 2008 training course, students use Visual Studio 2008 to explore the Visual Basic 2008 language. The course starts with a quick overview of the .NET platform, examining assemblies, Microsoft Intermediate Language, Visual Studio profiles, XML comments, IntelliSense, and debugging. From there, you will learn all the Visual Basic 2008 language features that you must internalize  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...

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 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...

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 SharePoint Designer is based on FrontPage technologies. It is a superset of Expression Web, which is also based on FrontPage. In addition to the web development features included in Expression Web, SharePoint Designer includes features specific to SharePoint, such as the ability to create, open, edit, backup and restore SharePoint sites and to create SharePoint master pages and web part pages.  more...

MOC 8819 - Payables Management I in Microsoft Dynamics GP 10.0 This Microsoft Dynamics GP Payables Management training class examines the accounting cycle and the processes required to enter vendor invoices and process checks. This class also shows how to perform additional functions such as adjustments, prepayments, month-end closing, and cash flow control.A thorough understanding of these topics allows for capitalizing on vendor discount dates to reduce  more...

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

MOC 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 This four-day course develops skills in JavaServer Pages, or JSP, which is the standard means of authoring dynamic content for Web applications under the Java Enterprise platform. It treats JSP 2.0, including older features such as scriptlets but focusing on newer features and techniques, including JSP expressions and the JSTL. At the end of the course, students will be well prepared to author  more...

Java Swing Training This 5-day course introduces the Java programmer to the Java Foundation Classes -- a.k.a. Swing -- the Java environment ' s comprehensive framework for GUI development. The student will study the fundamentals of the JFC architecture and quickly move to building simple JFC frame-based applications. By the end of the course the student will be comfortable building simple or complex interfaces with  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 In this C# training course, students use Visual Studio .NET 2008 to explore the Visual C# 2008 language. The course starts with a quick overview of the .NET platform, examining assemblies, Microsoft Intermediate Language, Visual Studio profiles, XML comments, IntelliSense, and debugging. From there, you will learn all the language features that you must internalize in order to create full-featured  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 This Microsoft Project training class provides students with the knowledge 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  more...

MOC 5927 - Microsoft Office Project 2007, Managing Projects This Microsoft Project training class provides students 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  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 The Manufacturing Executive Institute is pleased to bring you this LIVE & FULLY interactive "Virtual Classroom" workshop on Tuesday, May 10 at 10: 00 AM PDT. Participate in this virtual training event from the comfort of your office or home computer. Learn from an expert instructor AND your industry peers! Manufacturing professionals ALWAYS worry that production operation standards are  more...

A Case for Routine Use of Statistical Process Control SPC in Manufacturing ...ment 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 Every developed country has a pharmacopeia, including the European Union. This webinar will explore the function 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  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 ...a piecemeal fashion. Thus, each element in a manufacturer's control program has been implemented without regard for the effect of the other elements. As a result, potential complimentary synergies between control elements have typically been overlooked while gaping compliance issues may exist. A Contamination Control Master Plan (CCMP) is critical to help organize and streamline all of the  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 TRAINING DETAILS: Course Duration: 90 hours Training + Case Studies + 2 months Server access Training Materials: All attendees would receive a Assignment after each module, a Notes and study material for examples covered. a Access to the Training Blog Training Format: This course is delivered Online using Web and Audio Conferencing. Timing: Weekdays and Weekends after work  more...

Establishing a Reduced Testing Program for Pharmaceutical Medical Device Components Reduced testing test permits a medical product manufacturer to reduce testing 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.  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 The verification and validation of electronic records and electronic signature software is coming under increased scrutiny by the U. S. FDA. This webinar will address the use of FDA Guidance's, GAMP, 21 CFR Part 11, "Electronic Records" / "Electronic Signatures", and other applicable industry software validation models, coupled with the ISO 14971 / ICH Q9 Product Risk Management models, to  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 ...radiation, 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 Design Inputs, Design Outputs, and Traceability matrices present 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  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 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. 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  more...

DHF DMR DHR Technical File and Design Dossier - Key Requirements and Future Directions - Webinar By GlobalCompliancePanel Overview: This webinar will examine the existing and proposed requirements for the FDA's DHF - including its derivative documents, the DMR and DHR. It will consider the MDD's TF/ DD requirements, and evaluate the documents' differing purposes / goals. Required and desirable contents will be discussed. Also considered: Areas requiring frequent re-evaluation / update; Similarities and  more...

Pharmaceutical and Medical Device Validation Guidances - Similarities and Differences - Webinar By GlobalCompliancePanel Overview: This webinar will provide an overview of process validation for devices and pharmaceuticals. While most of the webinar will include FDA compliance requirements, there will be some International Standards Organization (ISO), European, and Canadian regulations included for exploration. After attending this webinar, attendees will have a greater perspective of process validation and its  more...

Develop and Execute the Company Software VV Program - Webinar By GlobalCompliancePanel Overview: The verification and validation of medical software is coming under increased scrutiny by the U. S. FDA. This webinar will address the use of the FDA, GAMP, 21 CFR Part 11, "Electronic Records" / "Electronic Signatures", and other applicable industry software validation models, coupled with the ISO 14971 / ICH Q9 Product Risk Management models, to structure, run, and document  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 Overview: 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. 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  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...

Facilities Cleaning in Cleanrooms and Controlled Environments - Webinar By GlobalCompliancePanel Overview: This live webinar concentrates on proper cleanroom cleaning, and discusses tools, equipment, agents, personnel training, extent, and frequencies. It is a very practical training session intended to assist personnel involved in the design, cleaning, monitoring, and assessment of cleanroom cleaning procedures. The key benefits of this course are: * In-dept understanding of  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...

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 Overview: This webinar will cover several recommendations to improve the hospital'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  more...

Bringing Compliance To Design Control For Older Products - Webinar By GlobalCompliancePanel Overview: The webinar examines critical parts of design 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  more...

Developing the Risk Management Plan - Webinar By GlobalCompliancePanel Overview: This presentation will review the requirements for the Risk Management Plan and discuss practical methods for meeting the requirements. Examples of documentation of the Plan will be presented, including Risk Acceptability Criteria, risk review, verification activities, and information collection activities. While Risk Management Plans can be part of the Quality Plans for a product,  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 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...

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...

Medical Device Recalls How to Manage Them and Recent Trends - Webinar By GlobalCompliancePanel Overview: Medical devices are classified into three 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  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...

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 ...a piecemeal fashion. Thus, each element in a manufacturer's control program has been implemented without regard for the effect of the other elements. As a result, potential complimentary synergies between control elements have typically been overlooked while gaping compliance issues may exist. A Contamination Control Master Plan (CCMP) is critical to help organize and streamline all of the  more...

Process Validation current industry practices and FDA Guidance Document Review - Webinar by GlobalCompliancePanel ... be, 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 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...

Medical Device Changes and The 510k - Webinar By GlobalCompliancePanel Overview: This webinar will examine the broad range of issues to be considered by a company when reviewing 1) A series of minor changes or 2) One major change to an existing product having an existing 510(k), for the need for a new 510(k). Such a review takes on added urgency as a result of the stated intent of the Agency to get tougher across the board in its expectations for the medical  more...

Project Management in a cGMP Environment - Webinar By GlobalCompliancePanel Overview: This webinar will provide valuable guidance to regulated companies in development and implementation of Project Management Planning and Techniques for new product development, regulatory compliance audit responses, proof of "progress against plan", and other activities requiring a planned documented rationale. Three of the most common tools will be discussed. One very simple approach  more...

Legal Risks in Social Media for Healthcare Providers - Webinar By GlobalCompliancePanel Overview: Most sophisticated businesses use social media sites such as Facebook, MySpace, Twitter, and LinkedIn to promote their services, connect with their customers, and as a overall component of their business strategy. Physicians and other healthcare providers have begun to experiment in the social media environment, but most are concerned that the special rules applicable to the  more...

Chemical Control for Food Manufacturers Ingredient Cleaning and Hazardous Materials - Webinar By GlobalCompliancePanel Overview: A comprehensive review of an ideal chemical 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  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...

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...

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 ...s 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 values to those risks, measuring the processes based on  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 ...materials Module 7: Technical and "Administrative" Process Controls Module 8: Introduction to Deviations & Quality Failures (0: 10) Module 9: Validation Module 10: Maintaining Label Control-From Design to Label Application Module 11: Storage and Distribution & Returned and Salvaged Products Module 12: Returned and Salvaged Products Module 13: Laboratory Controls Module 14: Problem  more...

How to Prepare and Submit a Bullet Proof 510k and Latest FDA Proposed Changes to the Process - Webinar By GlobalCompliancePanel Overview: This 3 hour Webinar is a primer and overview to the premarket notification process, i. e., a 510(k). A 510(k) is a premarket submission made to FDA to demonstrate that your device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device that is not subject to PMA. There are three types of Premarket Notification 510(k)s that may  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...

Preventive and Corrective Maintenance Protect your assets Protect your consumers - Webinar By GlobalCompliancePanel Overview: A how to guide to meeting customer expectations of the maintenance function. An overview of industry best practices and a review of some leading software solutions. Why you should attend: Maintenance is often found to present the greatest area of opportunity for improvement in the food safety chain. Lack of control of parts and condition of equipment often contributes foreign  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...

101 cGMP To-Do List for 2011 - Webinar By GlobalCompliancePanel Overview: This webinar will examine the broad range of issues a company's senior management and QA/ RA need to consider in their annual Management Review of their existing quality management system. Such a review takes on added urgency as a result of the stated intent of the Agency to get tougher across the board in its expectations for the medical industry and what it (the FDA and industry)  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 Most industries have become reasonably sophisticated in terms of applying the principals and tools involved in quality control and improvement. Unfortunately, food supply chain members have lived outside of the quality world and have not invested the time, training or money to learn and apply the disciplines needed to bring quality into preventive levels of control. Visual inspection in many  more...

Medical Device Classification - Webinar by GlobalCompliancePanel In 1976, the FDA received authority to regulate medical devices. The plan, written into law, establishes three risk classes for devices (I, II, and 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,  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 ... specification 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  more...

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

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

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...

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 In 2008, a new edition of ISO 9001 went into effect. The literature says the new version doesn't introduce any new requirements but only clarifications to the existing requirements. One of the clarifications involves the use of Outsourced Processes in the Quality Management System. The changes clarify the organization's responsibility for conformity to all customer, regulatory, and statutory  more...

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

Best Practices in Complaint Management - Compliance Webinar by GlobalCompliancePanel 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. This session will include the requirements  more...

Leadership in Manufacturing Contamination Control Webinar will be on March 18, 2010. Webinar will be presented by Teri C. Soli. The 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  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 ...ledge needed for optimizing the performance of your plant's controls. This training course will teach you the essentials of process dynamics, PID controllers, and tuning. It will also provide you with the know-how for identifying poor control, skills for fixing the problems and techniques for optimizing your control loops. Our instructor, Dr. Jacques Smuts, has dedicated his working life to  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...

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 ...cepts o Introduction to OOPs o Encapsulation o Access Control o Inheritance o Polymorphism o Best Practices o Exercises and Stand alone applications/ programs * JDK 1. 5 features o Enhanced for Loop o Generics o Enums o Annotations * Exception Handling o Exceptions Overview o Catching Exceptions o The finally Block o Exception Methods o Declaring Exceptions  more...