Operations Web-based Seminars

Health Information Technology Introduction ...health information technology (HIT) acquisition, use, and operations; or be a person who plan to take HIT Certification courses at their local college and/ or university. Each of the sessions below are three to four hours long. These sessions along with certification from an approved certification center will prepare you for a career in Health Information Technology. HCMI Solutions  more...

Health Information Technology Systems ...health information technology (HIT) acquisition, use, and operations; or be a person who plan to take HIT Certification courses at their local college and/ or university. Each of the sessions below are three to four hours long. These sessions along with certification from an approved certification center will prepare you for a career in Health Information Technology. HCMI Solutions  more...

Data Integration for Data Mining with Talend Open Studio OS ...a Customer Analytic Record (CAR) suitable for data mining operations. Talend OS is an Open Source tool; the client version is available for free download. The Talend company charges for the client/ server version of the tool and any support required for its installation and use. Data integration tools like Talend perform three classes of data operations: Extraction (E), Transformation (T), and  more...

Data Mining for CRM using STATISTICA Data Miner This course introduces you to the area of customer relationship management (CRM) and the STATISTICA Data Mining10. 0 interface. You are introduced to the different learning methods of parametric statistical analysis and data mining analysis, and introduced to the practice of combining several modeling algorithms (ensembles) to predict customer responses. The methodological emphasis of this course  more...

Data Mining for CRM using SAS-Enterprise Miner This course introduces you to the application area of customer relationship management (CRM) and the SAS-Enterprise Miner 6. 2 interface. Differences between the pattern learning approaches of parametric statistical analysis and data mining are presented and compared. Groups of algorithms are combined to form "ensembles" for more powerful prediction of customer response patterns. Customer behavior  more...

Data Manipulation Techniques Using a popular statistical software package you will learn basic data manipulation tasks such as: Bringing in different types of files (SPSS, SAS, txt, dat., excel, use the ODBC, etc); Clean data and address such issues as missing data, duplicate entries, outliers; Reshaping, aggregating, merging data; Performing such tasks as looping, vectors, beginning automations with macros specific to data  more...

Introduction to Statistics Using Common Software Packages This course measurably increases your ability to interpret, conduct, & write comprehensive marketing reports using statistics while training using Popular Statistics software. The primary goal of the course is to be able to determine which analysis is appropriate given the question and type of data given. The course will focus on pragmatic business applications, interpretations, presentation, and  more...

Oracle Database 10g: Administration Level II One of the most challenging tasks ever presented to Oracle database administrators is that of recovery from failure, especially if the recovery must not result in a loss of any data. This Oracle trainig class presents all the standard failure scenarios and the best recovery strategies for each. Strategies for on-line backups, complete and incomplete recovery, media recovery vs.  more...

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

SharePoint 2007 Operations Training ...Operations and targets administrators interested in learning every aspect of managing a SharePoint 2007 Server farm. This includes integration with applications like IRM, ForeFront, and Performance Point.This SharePoint training course is designed for individuals who access information on a Windows SharePoint team site or SharePoint site owners who are responsible for creating and managing a  more...

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

Introduction to Microsoft Access 2003 Training ...urse is designed for students who wish to learn the basic operations of the Access 2003 database program to perform their day-to-day responsibilities, and to understand the advantages that using a relational database program can bring to their business processes. The introductory Access course is for the individual whose job responsibilities include working with tables to create and maintain  more...

MOC 6421 - Configuring and Troubleshooting a Windows Server 2008 Network Infrastructure ...ing to be Enterprise Administrators (Tier 4 daily network operations) or Network Administrators (Tier 2). Experienced Server Administrators who aspire to be Enterprise Administrators will also benefit from this course.The secondary audience for this training class includes Storage Area Network Administrators who need to understand this information to deploy or extend their current storage  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 ...2. This montha ™s powerful 1-hour 3rd Thursday - a Operations Improvement Seriesa Webinar has five important objectives: 1. Learn how to organize for improved forecasting, including the role of the a Chief Forecaster.a 2. Understand the importance of equally considering past, present and future data in order to understand the direction and projected magnitude of customer  more...

The Most Important Metrics For Measuring Supply Chain Performance ... interacting over the webinara ™s audio channel. Operations and logistics organizations utilize a number of performance metrics to assess performance and lend direction to their enterprises. Some metrics seem to yield clearer insights than others. A core question on the mind of many executives is: a What are the BEST metrics for measuring global supply chain performance and which  more...

How to Factually Evaluate Critical Supplier Performance and Risks Manufacturers and distributors are choosing to source significant amounts of materials and components from global suppliers and are creating substantial risks within their supply chains. Companies are discovering that sourced-material disruptions can and often do, result in dramatic and unfavorable impacts to material delivery reliability, total material cost and received material quality.  more...

How to Conduct an Effective Monthly Variance Review Meeting It has been said that difference between a GOOD plant manager and a GREAT plant manager is often in how operating variances are routinely addressed and how corrective actions are routinely executed. Great plant managers always conduct a routine a Variance Review Meetinga each month, challenging their direct reports to explain all significant variances from plan. These variances are usually,  more...

JIRA Fundamentals Training Course Course Summary The JIRA Fundamentals training course provides the ideal jumpstart for your team to use JIRA more effectively. The material covers all features of the product from an end-user's perspective, and provides a solid foundation for users with all levels of experience, since it explains the most effective ways to use JIRA and some handy tips for getting the most value out of the  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...

Constructing a Component Criticality Matrix A Better Way to Identify Important Components ... The purpose of this montha ™s 3rd Thursday - a Operations Improvement webinar is to present a mechanism for identifying the parts that are most critical so that added planning and procurement attention can be applied. The Component Criticality Matrix is a tangible analytic tool that helps all Purchasing professionals to quantifiably determine how critical a part is to the overall  more...

How to Achieve Maintain ERP Systems Master File Data Integrity ...cutive Institutea ™s May 19th 2011 3rd Thursday - a Operations Improvement Series FREE webinar, How to Achieve & Maintain ERP Systems Master File Data Integrity. Contrary to the popular belief that modern, fully-integrated information systems provide executives with the tools to make more effective and efficient decisions, there is increasing evidence that this promise has not been  more...

Preserving Precious Capital Attacking the SEVEN Most Significant Capital Wasters in Your Company Times are tough and capital preservation is at the top of every executivea ™s priority list. But specific techniques necessary to rapidly eliminate waste and reduce operating costs can be difficult to define and even more difficult to implement. If you manage ANY type of an organization, you have waste which steals precious capital from your enterprise. Now, more than ever, it is important  more...

Integrative Activity Based Costing Leadership An Overview of Bottom Up Cost Accounting ...Operations Improvement webinar has 3 important objectives: 1. To demonstrate how a bottom-up version of ABCA can be used to better allocate support costs. With some commonly used value engineering tools, a new perspective of product cost can be developed. 2. To demonstrate how any standard cost accounting system can be made to calculate allocations based on activities instead  more...

Should Under-Utilized Capacity Costs Be Included in Work Center Burden Rates The Manufacturing Executive Institute is pleased to bring you this LIVE & FULLY interactive 90-minute "Virtual Classroom" webinar," Should Under-Utilized Capacity Be Included in Work Center Burden Rates?" When your factory is underutilized, your productsa ™ incremental fixed cost is increased. As your factory gets more utilized, the allocated incremental fixed-costs decrease, thus  more...

A Case for Routine Use of Statistical Process Control SPC in Manufacturing ...e Institutea ™s FREE February 2011 3rd Thursday - a Operations Improvement 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  more...

Demystifying the Calculations of Efficiency Utilization and Productivity ...cutive 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 morph, the original (and correct) use of the  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...

How to Calculate the Impact on Total Factory Costs from a One Percent Change in Planned Load ...xecutive Institutea ™s September 2010 3rd Thursday - Operations Improvement Series FREE webinar, How to Calculate the Impact on Total Factory Costs From a 1% Change in Planned Load. The largest cost driver in most manufacturing companies, outside of the cost of direct material, is underutilization of semi-fixed and fixed costs. These costs are the aggregated expenditures on plant,  more...

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

Three New Segmented P and Ls That Will Shake Your Understanding of Product Cost This 1-hour FREE webinar presents three new profit and loss statements that are the direct result of rethinking manufacturing cost accounting. These new formats are sure to forever change your thinking about how value is created... and destroyed... in a manufacturing enterprise.  more...

Building a Cost Reduction Curve to Estimate Future Raw Material Prices Annual raw material spend is usually the largest cost reduction opportunity in most manufacturing companies. By reducing the price of raw material items, a company is immediately reducing its cash outflow and increasing it liquidity. Further, reducing annual spend improves gross margins and allows for a more competitive finished goods pricing strategy if needed. The trick to systematically  more...

A Better Method for Cross Training Production Personnel ...g Executive Institutea ™s August 2009 3rd Thursday - Operations Improvement Series FREE webinar, A Better Method for Cross-Training Production Personnel. Companies that take cross training of production personnel seriously report as much as a 30% fewer direct labor employees than exact peer companies. They also report faster cycle times, higher fill rates and lower customersa ™  more...

Operations Improvements Monthly Webinar each month on the 3rd Thursday, this Webinar series addresses one or more SPECIFIC issues facing OPERATIONS professionals in the maufacturing and distribution industries.  more...

Introduction to Contamination Control Master Plans - By GlobalCompliancePanel Why you should attend: Manufacturers 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  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...

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...

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

CAPA Challenges and FDA Expectations - By GlobalCompliancePanel CAPA and the related tools of Failure Investigation and Root Cause Analysis (RCA) is a major tool in product complaint, non-conformance, and OOS failure investigations, and hazard analysis / risk management and mitigation activities.  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...

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...

Failure Mode Effects Analysis FMEA - The Tool of Choice to Improve Product and Process Reliability and Efficiency While Reducin Failure Mode and Effects Analysis is a tried an proven technique to improve the quality, reliability and safety of products and processes in a proactive manner. It has been used successfully for over 60 years in very type of industry and in all stages of product development, process improvement projects. It helps to increase customer satisfaction, by proactively addressing failures that keep us  more...

Good Documentation Practices for Laboratory Operations Whether you work in production or in a laboratory or if you conduct investigations or finalize product release, sound data and information is essential to success and compliance  more...

Good Documentation Practices for Laboratory Operations - Webinar By GlobalCompliancePanel Overview: Whether you work in production or in a laboratory or if you conduct investigations or finalize product release, sound data and information is essential to success and compliance. To ensure success and avoid those frustrating, embarrassing discussions of missing or doubtful data, laboratory personnel need to be informed of these requirements, recognize their significance to their job  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...

HIPAA Security Policies and Procedures Making them useful and relevant as well as compliant - Webinar By GlobalCompliancePanel ...t takes to get in compliance and stay there, even as your operations and environment change. Find out what administrative, physical and technical safeguards are necessary and what policies they call for, and how you decide whata ™s right for HIPAA security compliance for your organization. This teleconference will provide the background and details necessary to develop an understanding of  more...

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

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

Developing the Master VV Plan to Meet US FDA ISO 13485 and 14971 Requirements - Webinar By GlobalCompliancePanel Overview: FDA Warning Letters and recent high-profile recalls indicate major cGMP deficiencies in many companies. One major failing is lack of sufficient or targeted risk-based company-wide V&V planning. Starting with a Master Validation Plan, evaluating its elements against ISO 14971 hazard analysis / risk management, allows development of meaningful product validations. The roles of different  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...

Conducting Successful Product Complaint Investigations - Webinar By GlobalCompliancePanel Overview: This webinar will provide valuable assistance and guidance to the life sciences manufacturers engaged in various aspects of product complaint investigations. An effective complaint handling system is an extremely important part of any quality system. Manufacturers should understand that any complaint received on a product shall be evaluated and, if necessary, thoroughly investigated  more...

How to successfully create a Device History Record and keep FDA happy in the process - Webinar By GlobalCompliancePanel Overview: Many companies are confident that their record keeping for the firm's device history records is compliant to the Quality System regulation, yet when the FDA comes calling, FDA 483 DHR cites are written and warning letters, seizures or worse ensue. Internal Audits show the production controls system compliant, yet again FDA writes the firm up. This webinar will review the production  more...

Best Practices for the Implementation and Use of Test Management Tools - Webinar By GlobalCompliancePanel ... provide details regarding Implementation, Configuration, Operations, System Maintenance, Training and Testing Automation considerations. Why should you attend: This webinar will address the benefits of implementing a Test Management Tool to manage the validation life cycle, considerations for the implementation project of a Test Management Tool, Test Management Tool Operation/ Maintenance  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...

Good Documentation Practices for GMP Operations - Webinar By GlobalCompliancePanel Overview: Whether you work in production or in a laboratory or if you conduct investigations or finalize product release, sound data and information is essential to success and compliance. To ensure success and avoid those frustrating, embarrassing discussions of missing or doubtful data, laboratory employees must follow good documentation practices. According to the FDA, if it isn't written  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...

Regulatory Complaint Handling Vigilance Recalls - Webinar By GlobalCompliancePanel Overview: Improper complaint handling can result is serious regulatory problems as well as hitting the bottom line. Recalls, FDA Warning letters & even seizures could result. This presentation will review the regulatory requirements for complaint handling and adverse events reporting in the USA, EU & Canada. Suggestions for investigating and documenting complaints & pitfalls will be included.  more...

FDAs Proposed Rule Regarding Device Establishment Registration and Listing and How to Register and List - Webinar By GlobalCompl Overview: Device firms, establishments or facilities that are involved in the production and distribution of medical devices intended for use in the U. S are required to register annually. Most establishments that are required to register with the FDA are also required to list the devices that are made there and the activities that are performed on those devices. FDA issued a 28-page Proposed  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...

Meet FDA Expectations for a Tougher Supplier Audit Program - Webinar By GlobalCompliancePanel Overview: There is a pervasive public perception that the FDA has been ineffective in protecting the public. Recent news events seem to support this perception. The FDA is working hard 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 evaluate the effects that this call  more...

Developing and Using the Product Risk Management FileReport - Webinar By GlobalCompliancePanel Overview: Expectations for meaningful hazard analysis, hazardous conditions, and documentation have always existed by regulatory agencies. There is an increased awareness of the importance of design activities to support the production of safe and effective product. Product risk management is a required tool to drive and direct resource constrained product design, manufacture and validation  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 Overview: This webinar concentrates on the value of creating a master plan for contamination risks within a GMP manufacturing company. It provides an introduction to the creation, 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  more...

Cleanroom HEPA Filter Testing Certification An Owners Guide - Webinar by GlobalCompliancePanel Overview: This webinar concentrates on identifying and discussing testing and certification requirements associated with cleanrooms. The key benefits of this course are: * In-dept understanding of industry standards, processes, and criteria for testing cleanrooms and HEPA filters * Achieve satisfactory inspections more easily * Higher assurance of new medical product approvals  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...

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

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...

Preparing for GFSI and other Third Party Audits - Webinar By GlobalCompliancePanel ...re as much a function of proper preparation as day to day operations. Find out what you need to know to achieve success. Areas Covered in the Session: * Description of the various audit schemes. * Common methods of preparation * Unique requirements * Unspoken rules * Tips for scheduling and executing a successful audit * Guidelines for preparing corrective  more...

Chemical Control for Food Manufacturers Ingredient Cleaning and Hazardous Materials - Webinar By GlobalCompliancePanel ... and intentional contamination can occur in even the best operations. Proper chemical control can minimize risk, resulting in better risk ratings and greater customer confidence. While regulatory and audit guidelines can be vague at best, auditors have increased their vigilance in this area due to the recent focus on biosecurity and food safety. Learn and teach your team to implement a world  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...

Using Foreign Trial Data in Your NDA Approval Process - Webinar By GlobalCompliancePanel Overview: In this NDA Approval Process training Webinar learn the guidance and regulations governing FDAa ™s acceptance of foreign trial data and know how FDA implementing these rule along with design considerations and requirements for foreign trials. Why you should attend: While the law allows 100 percent of pivotal data to come from foreign trials, there have been very few such  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 ...ent. A systematic approach to maintenance is critical to operations, quality and safety. Areas Covered in the Session: * How to prepare an audit policy and program * A sample checklist for documenting audit results * What to look for * Where to look * Establishing evidence of corrective actions * Trend analysis and sustainable improvement Who will benefit:  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...

Webinar on Pharmacovigilance Audit - Webinar by GlobalCompliancePanel This webinar will describe how to conduct a thorough drug safety and pharmacovigilance audit, including compliance with applicable worldwide laws, regulations and guidance. In addition, attendees will learn how to compare the company's pharmacovigilance operations to applicable best practices. The course will cover all aspects of drug safety and pharmacovigilance compliance including the  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...

FDA 483 Observations in the Laboratory What went wrong How can they be avoided - Webinar By GlobalCompliancePanel ...l focus on the laboratory and recent FDA laboratory based operations. We will review observations, identify the real issue and suggest actions to prevent similar observations in other laboratories. Why you should attend: An FDA 483 observation can have an impact on any unit within a firm and laboratories have received more than their share. Since the early 1990s, the investigators have  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 Advantages of Linking Management Systems - Webinar by GlobalCompliancePanel Overview: It's important to improve the dialogue between financial, quality, IT and environmental management systems. Members of these management systems need to understand what the others do. Quality and environmental managers need to understand the language of finance and the effect of operations on the bottom line, while financial managers need to know how quality, environmental and IT  more...

HIPAA Compliance and Workforce Training for Medical Practices - Webinar by GlobalCompliancePanel ...ther purpose outside of treatment, payment, or healthcare operations, you may need to have the patient sign a proper authorization form with specific details defined by the regulations. If your staff is not aware of all of these restrictions and requirements, and more, you may be jeopardy of violating HIPAA requirements. As for the Security Rule, extensive policies and procedures are needed to  more...

European Drug Safety and Pharmacovigilance Compliance - Webinar by GlobalCompliancePanel This webinar will describe European PV requirements, including compliance with applicable laws, regulations and guidance. In addition, attendees will learn how to compare the company's PV operations to applicable best practices in Europe.  more...

Signal Detection and Case Processing Business Process Optimization in Pharmacovigilance - Webinar by GlobalCompliancePanel ...ill describe how to assess and optimize pharmacovigilance operations from cost effective, compliance, and safety perspectives. A structured methodology for assessing drug safety operations will be presented. This will include recognizing the need to conduct process analysis, developing and prioritizing project portfolio, performing the analysis, and finally implementing the findings. The  more...

Applying Lean IT Principles to your IT department to identify opportunities to reduce waste and increase efficiency GlobalCompliancePanel brings a new webinar for the medical devices industry professionals. Webinar will be on March 30, 2010. Webinar will be presented by Bernice Russell Bond. Bernice brings over fifteen years of business operations, risk management, audit and compliance experience. She has worked for business, legal, audit, and IT management groups within various industries including  more...

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

Complete Java Training ...SQL Query o Getting the Results o Updating and Insert operations * Statements and Prepared Statements o Executing SQL Queries o ResultSetMetaData o Executing SQL Updates o Using a PreparedStatement o Parameterized Statements * Stored Procedures o Creating a stored procedure o Executing Stored Procedure with CallableStatement * Transactions o Transaction Management *  more...