Changes Web-based Seminars

Call Center Social Media Certification - Live Online - May 9-11 2012 ...changes in consumer media behavior in history, resulting in fundamental shifts in the way companies communicate and interact with consumers. This course provides the practical knowledge and insights required to establish objectives and strategies and to properly select the social media platforms to engage consumers, while monitoring and measuring the results of these efforts. Live Online  more...

Call Center Social Media Certification - Live Online - October 3-5 2012 Social media represents one of the most significant changes in consumer media behavior in history, resulting in fundamental shifts in the way companies communicate and interact with consumers. This course provides the practical knowledge and insights required to establish objectives and strategies and to properly select the social media platforms to engage consumers, while monitoring and measuring  more...

MOC 8691 - Fixed Assets I in Microsoft Dynamics GP 10.0 ...tional functions such as changing asset information, mass changes, partial transfers, partial retirements, and retirement undo.A thorough understanding of these topics allows companies to keep accurate records and learn to use comprehensive reporting features to present data in different ways. This Dynamics GP class also teaches how to define default values that automatically populate data  more...

Managerial Leadership Training ...zation ' s vision, and discuss the importance of planning changes before implementing them. Course activities also cover preparing employees for organizational changes, motivating employees through change, solving problems encountered during change, and helping employees deal with grief and stress during changes. Students will also learn how leaders can help employees learn their roles in  more...

Ajax Training ...x allows for more dynamic and responsive applications, it changes the traditional role of JavaScript dramatically and forces developers to rethink how they write and manage JavaScript code. After taking this Ajax training course, students will be able to create sophisticated Ajax-based applications in an efficient and modular way. For those new to CSS, XML, XSLT and/or JavaScript, this Ajax  more...

Change Management Training This change management training course teaches students how to develop the skills to proactively address change and meet the challenges of transition in the workplace. Students will work with various employees to overcome the problems encountered when making changes in your organization. Students will also learn how to develop the ability to effectively handle organizational changes by examining  more...

Measuring Performance of Your Global Procurement Organization How to Shape Behaviours in Global Purchasing ...ning how a 1% reduction in purchase-spend translates into changes in enhanced profits, reduced gross assets and improved enterprise valuation. - How should procurement function metrics be aligned with other metrics in a global sourcing manufacturing company and how do you get your critical Suppliers to align their performance metrics with yours? Participants in this montha ™s  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...

FDA Requirements for Device Labeling Development Contents Distribution and Changes - Webinar GlobalComplianceP Overview: Marketing wants to entice customers to buy your product instead of your competitor's! A common method is to make the labeling as eye-catching as possible. Wednesday, May 16, 2012 10: 00 AM PDT | 01: 00 PM EDT  more...

Bullet Proof 510k Latest FDA Proposed Changes to the Process - Webinar By GlobalCompliancePanel Overview: 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. Tuesday, June 26, 2012 10: 00 AM PDT | 01: 00 PM EDT  more...

Device Changes and the 510k - Webinar GlobalCompliancePanel Overview: The majority of medical devices are cleared for marketing in the U. S. by the FDA under the 510(k) process. Wednesday, May 9, 2012 10: 00 AM PDT | 01: 00 PM EDT  more...

New Final HIPAA Amendments New final rules for HIPAA Expand the Scope and Increase Responsibilities ... regulations. It will provide a comprehensive look at the changes in the law and prepare attendees for the process of incorporating the changes into how they do business in their facilities. Areas Covered In the Session: The new regulations will be reviewed and their effects on usual practices will be discussed, as well as what policies need to be changed and how. We will show what  more...

FDAs Revised Draft Guidance on Medical Device Changes and the 510k - Webinar By GlobalCompliancePanel This webinar will discuss the new draft guidance document from the FDA: "510(k) Device Modifications: Deciding When to Submit a 510(k) for a Change to an Existing Device", dated July 27, 2011. Wednesday, January 25, 2012 10: 00 AM PST | 01: 00 PM EST  more...

Changes in the EU Medical Device Directives 2010 Modifications and the 2012 Recast of the MDD Directives -Changes in the EU Medi This webinar is focused on understanding the requirements of the Medical Device Directives, their linkage to the EU Clinical Trial Directive and the requirements of CE Marking and ISO Certification on commercializing products. Tuesday, March 13, 2012 10: 00 AM PST | 01: 00 PM EST  more...

Bullet Proof 510k - Latest FDA Proposed Changes to the Process - Webinar By GlobalCompliancePanel 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. Thursday, November 17, 2011 10: 00 AM PST | 01: 00 PM EST  more...

New Amendments of Critical Parameters in Canadian Clinical Trials - Webinar By GlobalCompliancePanel ...changes that occurred in Canadian ethics regulations. The presentation will clarify for sites and sponsors how to easy the ethics process and how to get more quicker the ethics approval. Also after the presentation the participant will understand how to apply the last changes in ethics regulation in the day-to-day work. Every member of the study team and site staff participating in the clinical  more...

2012 New and Changed ICD-9- CM Codes - Webinar By mentorhealth Don't miss this opportunity to learn about all of the ICD-9-CM changes for 2012. It is imperative that all coders stay current on changes in the official ICD-9-CM codes and be prepared to implement those changes by October 1st. Wednesday, October 5, 2011 10: 00 AM PDT | 01: 00 PM EDT  more...

Meeting Annual US FDA cGMP Training Requirements - Webinar By GlobalCompliancePanel 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. Wednesday, October 5, 2011 10: 00 AM PDT | 01: 00 PM EDT  more...

HIPAA Accounting of Disclosures Expanded scope in proposed rule means new obligations The session will walk the listener down the path from the current HIPAA Accounting of Disclosures rule, through the HITECH Act's required changes, and the into the proposed rule to implement HITECH which goes beyond what was required in the law and establishes a new right to an Access Report of all electronic PHI.  more...

HIPAA Accounting of Disclosures Expanded scope in proposed rule means new obligations by gcp The session will walk the listener down the path from the current HIPAA Accounting of Disclosures rule, through the HITECH Act's required changes, and the into the proposed rule to implement HITECH which goes beyond what was required in the law and establishes a new right to an Access Report of all electronic PHI.  more...

Device Changes and the 510k - Webinar By GlobalCompliancePanel ...impact safety / effectiveness, or when a series of lesser changes finally reach the "tipping point". This is a major headache. How can companies make that determination? How can they trigger such an analysis over the major change or the series of smaller changes. What approaches are required for product changes; for process changes. How is the process risk-based? How to maximize the process  more...

HIPAA Enforcement and Compliance Audits What the auditors want and how to be ready before they call - Webinar By GlobalComplianc ...will explain the enforcement regulations and their recent changes that increase fines and create new penalty levels, including new penalties for willful neglect of compliance that begin at $10, 000. We will discuss what information and documentation needs to be prepared in advance so that you can be ready for an audit without notice. Sample information request forms and questions asked at prior  more...

HIPAA Security Policies and Procedures Making them useful and relevant as well as compliant - Webinar By GlobalCompliancePanel ...ons as part of a security management process. Proposed changes and expansions to HIPAA, going into effect in 2011, dramatically expand the types of entities to which the regulations directly apply, which means that more entities than ever need to adopt the proper HIPAA Security policies and procedures to be in compliance. HHS compliance audit activity and enforcement penalties are both  more...

Information Security and Payment Card Rules Protecting Patient Payment Data and Complying with PCI - Webinar By GlobalCompliance ...as well as provide up-to-date information on any expected changes. Attendees will learn what information is covered under the HIPAA and PCI rules and what are the ways the information should be protected, including the safeguards called for by HIPAA and PCI. They will learn what are the consequences of not protecting health and payment information and what to do if their information security  more...

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

Conducting Successful Product Complaint Investigations - Webinar By GlobalCompliancePanel ...fore a trend is spotted that causes a company to initiate changes in their product, labeling, packaging or distribution. The regulatory expectations for both pharmaceuticals and medical devices will be emphasized as well as overview of best practices for timely and effective investigations. Areas Covered in the Session: * Understand how and why CAPA is tied in to product complaint  more...

Webinar on Cloud Computing SaaS - Webinar By GlobalCompliancePanel ...gement will also be discussed, with regards to how Vendor changes and customer configurations affect the validation and the testing that will be required to maintain a validated state. Why should you attend: If cloud computing is so potentially important and valuable, why is it so feared? The biggest fear in regulated industries is maintaining a compliant system that is not fully controlled  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...

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...

Elements of the Lot Disposition Process - Webinar By GlobalCompliancePanel ...ckages for approval and rejection of materials, and cover changes in disposition status. The course will not cover the disposition of raw materials, third party (CMO) manufacturing, or validation lots. Why should you attend: The process for the disposition of product lots can be tedious and overwhelming. The requirements for intermediates, Active Pharmaceutical Ingredients (API), drug  more...

HIPAA Business Associates How the regulations have changed and what you need to do for compliance now - Webinar By GCPanel ...Compliance Audit Agenda: * Old Ways, New Ways - Changes to the Rules o Origins of Changes to Business Associate Rules o New Definitions of Business Associates o Contractors of Business Associates * New Requirements and Changed Requirements for HIPAA Business Associates o HITECH Act Required Capabilities o Required Amendments  more...

HIPAA Breach Notification What to do to prevent breaches and what to do when they happen to you - Webinar By GCPanel ... o State Breach Notification Laws o Changes to HIPAA o Federal Breach Notification Law and Regulation o The Who, What, and How of Breach Notification * Preventing and Preparing for Breaches o Using an Information Security Management Process o Using Risk Analysis and Risk Assessment o The HIPAA Security Safeguards  more...

FDAs Proposed Rule Regarding Device Establishment Registration and Listing and How to Register and List - Webinar By GlobalCompl ...d Rule).The Proposed Rule contains four types of proposed changes to FDA's device establishment registration and device listing regulations. For example, Proposed Rule would amend FDAa ™s current regulations to make them consistent with provisions of the 2007 FDAAA pertaining to electronic device establishment registration and listing, many of which FDA has already implemented. Second, the  more...

XML Training ...Sharing Simplifies Data Transport Simplifies Platform Changes Makes Your Data More Available Used to Create New Internet Languages 4. VIEW AND EDIT XML FILES Sample XML file Viewing XML files List of Browsers Editing XML files Free XML editors 5. XML DOCUMENT STRUCTURE Sample XML document XML Tree XML Syntax Comments in XML Special characters Parts of an  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 ...he 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 recent public concern over insufficient  more...

Excel Spreadsheets and FDA Device Regulations - Webinar by GlobalCompliancePanel ...use of Protection to prevent inadvertent and unauthorized changes. To satisfy the broadest interest, we use Excel 2003 to illustrate the tools. The seminar shifts to the regulations for automated processes, found in 21 CFR 820. 70(i), and explains the requirements for a validation plan. The FDA Guidance document, General Principles of Software Validation, has a section devoted to this kind of  more...

International Financial Reporting Standards The Basics - Webinar by GlobalCompliancePanel ... the U. S. has begun the process. Are you ready for these changes? Why should you attend: If you are an accounting professional you need to become familiar with exactly what these new International Financial Reporting Standards consist of, and what these changes mean for companies. Areas Covered in the Session: * GAAP vs. IFRS * What will change * What will not change  more...

Medical Device Changes and The 510k - Webinar By GlobalCompliancePanel ...dered 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 industry and what it (the FDA and industry) need to do to "toughen"  more...

Validating Excel and Word Applications Documents - Webinar By GlobalCompliancePanel ...their existing system in light of current and anticipated changes in regulatory thinking, and in approaches to implementing necessary changes, in a realistic, risk-based approach. Why should you attend: Pressure is increasing on the FDA to get tougher on industry. The FDA has responded. * How does that impact companies' use of COTS (commercial off the shelf) office applications  more...

Complying with HIPAA Security Rules Whats in the rules and how you can most easily prepare for compliance - Webinar By GlobalCom ...ver-increasing use of electronic records and systems, and changes in how you do business, now is the time to review and renew your information security program and avoid violations and penalties for non-compliance. Areas Covered In the Seminar: * Learn what kinds of entities are now covered under the HIPAA Security Rule * Find out how the rules have changed and will continue to  more...

How to Prepare and Submit a Bullet Proof 510k and Latest FDA Proposed Changes to the Process - Webinar By GlobalCompliancePanel ... * Understand the potential impact of FDA's proposed changes to the 510(k) process and why manufacturers need to pay attention Detailed Agenda: Introduction and Regulatory Background * There is no 510(k) form; however, 21 CFR 807 Subpart E describes requirements for a 510(k) submission. * Current trends with the 510(k) process. The Process * Who is Required to  more...

Design History File DHF Device Master Record DMR Device History Record DHR and Technical File TF - Regulatory Documents Explaine ... o TF and OEM relationship * Design/ process changes and DHF, DMR, DHR, and TF Who Will Benefit: This Webinar is designed for people involved in document preparation and maintenance, and those who have involvement with documentation. This typically includes: * Quality Managers/ Engineers * Production/ Process Managers/ Engineers * Manufacturing Managers/  more...

New Changes to HIPAA The latest changes in the regulations and what they mean to you - Webinar By GlobalCompliancePanel ...s, and procedures to see of they are prepared to meet the changes in the rules. Covered entities that use electronic health records (EHRs) will need to meet new access and disclosure rules and all kinds of business associates and their subcontractors will need to establish compliance programs. And the regulations include new requirements for audits by the US Department of Health and Human  more...

Japan - Regulatory Filing Requirements and Compliance Processes for Life Sciences - Part I and Part II - Webinar By GlobalCompli ...encies Involved / Reporting Structure o Recent Changes to MHLW / PMDA to Speed Review + MHLW (Ministry of Health, Labour and Welfare) + PMDA (Pharmaceutical and Medical Device Agency) + PAFSC (Pharmaceutical Affairs and Food Sanitation Council) o Patents and Trademark Considerations * Beginning Your Company  more...

How to Prevent or Handle Protocol Deviations and Violations to be GCP and Regulatory Compliant - Webinar By GlobalCompliancePane ...owing the protocol? * When may the Investigator make changes in the protocol? * What are the causes of Protocol Deviations and Violations? * How are Protocol Deviations managed? * Examples of Protocol Violations and Deviations Who Will Benefit: * Principal Investigators / Sub-investigators. * Clinical Research Scientists (PKs, Biostatisticians,) * Safety  more...

HIPAA Compliance and Workforce Training for Medical Practices - Webinar by GlobalCompliancePanel ... have access to their medical records and even asking for changes to their records or asking to have special restrictions placed on their records. If you want to use health information for some other 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  more...

FDAs Update on Medical Device Labeling Changes - Webinar by GlobalCompliancePanel ...arameters in which a device manufacturer can modify label changes to a product. Specifically, manufacturers can add or strengthen the contraindications, warnings, precautions or adverse reactions sections of labeling via a PMA supplement without prior FDA approval only when such modifications are based on newly acquired information and evidence of a causal association between the product and  more...

Revamping the 510k Clearance Process-Understanding FDAs Proposals - Webinar by GlobalCompliancePanel ...ical studies will be required. You will learn of possible changes in the de novo process that could streamline the clearance process. There will be new definitions of "Substantial Equivalence" and "intended Use" will be redefined and "Indications for Use" eliminated The FDA will likely increase the requirements for the Summary of Safety and Effectiveness and require a summary of all scientific  more...

The HITECH Acts Impact on HIPPA - Webinar by GlobalCompliancePanel The new requirements of the HITECH Act have a significant impact on the privacy and security of health information. This webinar will cover the changes required by the HITECH Act and the actions that needed to taken regarding breach notification, business associate contracts, training of staff and security of PHI for business associates. We will also discuss the best practices for data  more...

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

Outsourced processes and ISO 90012008 - Webinar by GlobalCompliancePanel ...utsourced Processes in the Quality Management System. The changes clarify the organization's responsibility for conformity to all customer, regulatory, and statutory requirements. The changes reinforce the need for control over outsourced processes and recommend using the methods found in the ISO 9001 Purchasing clause. These changes also include suppliers who are part of the same parent  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...

HIPAA Accounting of Disclosures and EHRs How the Rules are Changing and What Your Systems Need to Provide - Webinar By MentorHea ...ng of Disclosures rule, through the HITECH Act's required changes, and the into the proposed rule to implement HITECH which goes beyond what was required in the law and establishes a new right to an Access Report of all electonic PHI. First the current rule will be explained and issues pertaining to that will be discussed, followed by an explanation of the changes the HITECH Act calls for.  more...