Under Web-based Seminars

From Hiring To Firing What Every Manager Needs to Know ...ADA, ADEA, GINA and USERRA. Learn how to avoid liability under each of these statutes. Find out how each of these laws interacts with the others to ensure that your company is in full compliance and adequately protected. Most employers do not know that in many states the state employment discrimination laws apply to employers with small numbers of employees such as 4 or more employees. In  more...

Top Tips For Managers to Prevent Harassment in your Workplace ...understand what their responsibilities are and learn tips to help them prevent harassment in the workplace. This interactive, informative sexual harassment prevention training, "Top 10 Tips for Preventing Harassment in Your Workplace," will provide the tips that managers should not be without. It includes a definition of sexual harassment and discussions of quid pro quo and hostile work  more...

HIRING DOS AND DONTS This one-hour on-line live interactive webinar will provide managers with top tips to avoid liability when hiring employees. Learn what questions you can and cannot ask during the interview process. Learn how to avoid asking questions that can lead to discrimination claims later on. Also, learn what employment-at-will really means and how to avoid losing your right to hire or fire at-will.  more...

TOP 10 FMLAADA MISTAKES EMPLOYERS SHOULD AVOID Learn how to avoid the pitfalls of the FMLA and ADA. Get the latest on the Amendments to the FMLA and ADA as well as the Department of Labor revisions to the FMLA Regulations. Stay Informed! This one-hour live on-line webinar provides all the information that you need to know to ensure compliance with the FMLA and ADA. Learn how to recognize a serious health condition and how to designate that  more...

Comprehensive JSP Training ...d 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 JSPs for small- or large-scale Web applications, either " by hand " (they use only  more...

Java Swing Training ...JFC ' s strict use of the Model-View-Controller paradigm. Understanding the thorough use of this pattern in JFC is critical to using the framework effectively. Event handling is treated, both handling AWT-style events, such as action events from button clicks, and handling events fired by the model that lies under a particular control. In the second module, more sophisticated and powerful  more...

Introduction to JavaServer Pages ...d means of authoring dynamic content for Web applications under the Java Enterprise platform. The module begins with an introduction of Web applications in general, shows how Java servlets and JSPs establish a framework for writing Web applications, and then covers JSP 2.0 features in detail, from scripting elements to use of dedicated JavaBeans to JSP expressions, and quick introductions of  more...

Should Under-Utilized Capacity Costs Be Included in Work Center Burden Rates ...nteractive 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 increasing your companya ™s gross margins. But what happens to product gross  more...

New Final HIPAA Amendments New final rules for HIPAA Expand the Scope and Increase Responsibilities ...understand what they have to do, and when, and what to keep in mind as they move forward, in order to be prepared for compliance with the new regulations. It will provide a comprehensive look at the changes in the law and prepare attendees for the process of incorporating the changes into how they do business in their facilities. Areas Covered In the Session: The new regulations will be  more...

Master Verification Validation Planning under US FDA CGMP ICH Q-series and ISO 13485-14971 Requirements - Webinar By GlobalCom FDA Warning Letters and recent high-profile recalls indicate major cGMP deficiencies in many companies. Wednesday, March 21, 2012 10: 00 AM PST | 01: 00 PM EST  more...

Risk Management in IEC 60601-1 Third Edition - Webinar By GlobalCompliancePanel ...rements of the Third Edition. Manufacturers with products under development must start now to develop compliance strategies. The first step will be understanding the requirements of the new standard. Areas Covered in the Session: ISO 14971 compliance is a requirement of IEC 60601-1 The new standard uses risk management throughout The new standard is less prescriptive in many areas The  more...

Advanced HR Audit Techniques - Webinar By TrainHR ...d 4) the organizationa ™s human capital adds value. Under this definition, HR audits are more than an assessment that solely collects and presents evidence of compliance. HR audits are increasingly expected to look behind and beyond the organizationa ™s assertions of sound and proper HR management practices and to assess the assumptions being made, benchmark the organizationa ™s  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...

How to Prevent or Handle Protocol Deviations and Violations to be GCP and Regulatory Compliant - Webinar By GlobalCompliancePan ...under what circumstances, when the protocol is not followed (PNF) and why this is of particular significance. Covered, will be how a protocol deviation with the least significant effect where there is no substantive effect on the risks to research participants, no substantial effect of the value or integrity of the data, and did not result from willful or knowing misconduct on the part of  more...

Software Verification and Validation Planning to Meet FDA Requirements - Webinar By GlobalCompliancePanel The verification and validation of medical software is coming under increased scrutiny by the U. S. FDA. Wednesday, October 19, 2011 10: 00 AM PDT | 01: 00 PM EDT  more...

Use and Mis-use of FMEA in Medical Device Risk Management - Webinar By GlobalCompliancePanel This webinar will update personnel at medical device companies on the ISO 14971 standard and point them to the additional information available in the document under the informative annexes. The information will assist in meeting various national and global regulatory requirements for medical devices.  more...

A Simpler Approach to Implementing or Validating CGMPs to 21 CFR 11 Electronic Records Signatures - Webinar By GlobalComplianceP ...ronic 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 structure, run, and document acceptable  more...

Importing and Exporting Medical Devices A Primer on Regulatory Strategy and Requirements by GCP Any medical device that is legally in the U. S. may be exported anywhere in the world without prior FDA notification or approval. The export provisions under section 802 of the FD&C Act only applies to unapproved devices  more...

Breakthrough Performance Management that is Practical Effective and User-Friendly ...fter a review session when it is conducted the right way, under the right conditions, using the right technique. Traditional appraisals are an outdated approach to productivity. The performance conversations approach is productivity improvement methodology. Appraisal ratings are often too subjective and are the source of disagreement, debate, and sometimes anger. Employees look at their rating  more...

The Law and Psychology of Mental Health Issues at Work Substance Abuse Depression and the Bermuda Triangle of the ADA the FMLA a ...understand how to navigate the difficult and often murky challenge of dealing with "invisible disabilities." To make matters more confusion, the recent amendments to the A. D. A. have a significant impact on the rights of mentally employees as well as the responsibilities of employers. This practical workshop address both the legal and psychological issues that often arise, such as  more...

Document Retention and Destruction ...r to be sure both you and your staff in charge of records understands the responsibility and importance of knowing and following proper procedures. When auditing how information is kept by Human Resource Departments, many questions come up regarding where records are kept, how long they should be kept and when and how they should be destroyed in order to stay in compliance. Effective Human  more...

Preventing Harassment in the Workplace by TrainHR This webinar will concentrate on what is considered sexual harassment as well as covering other types of harassment in the workplace. It will review the laws protecting employees from harassment and the recourses employees have. It will define who is covered and describe the two main kinds of sexual harassment in the workplace. It will cover what should be in an effective Harassment policy, how  more...

ISO 13485 as a Quality Management System for Medical Devices by GlobalCompliancePanel ...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 certified to ISO 13485: 2003 will  more...

Device Changes and the 510k - Webinar By GlobalCompliancePanel ...devices are cleared for marketing in the U. S. by the FDA under the 510(k) process. The FDA holds companies responsible for filing new 510(k)s when one change is major enough to 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  more...

HIPAA Security Policies and Procedures Making them useful and relevant as well as compliant - Webinar By GlobalCompliancePanel ...l phones, and portable data devices. All entities covered under HIPAA must take special care of electronic patient health information, including establishing policies and procedures to protect all kinds of PHI and taking regular actions 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  more...

Information Security and Payment Card Rules Protecting Patient Payment Data and Complying with PCI - Webinar By GlobalCompliance ...nges. 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 is compromised. We'll talk about strategies to limit  more...

Develop and Execute the Company Software VV Program - Webinar By GlobalCompliancePanel ...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 acceptable software  more...

Recalls Vigilance - When to Report Complaints - Webinar By GlobalCompliancePanel ...properly evaluate medical device complaints for reporting under 803 & 806 regulations. Vigilance reporting is also required in Canada, the European Union and many other countries. Warning letters and recalls are posted on FDA's website and published in trade magazines, newspapers available to firms' competitors. Areas Covered in the Session: * Complaint definitions - FDA, Canada &  more...

Data Security Analysis for Healthcare Providers - Webinar By GlobalCompliancePanel ...their risk analysis and security analysis obligations are under HIPAA and the new "meaningful use" rules under the HITECH Act. Attendees will receive questionnaires and checklists that can be adapted for use by a healthcare provider to conduct a targeted risk analysis and meet HITECH and HIPAA requirements. Areas Covered in the Session: * "Meaningful Use" data security analysis  more...

Understanding ISO 13485 vs ISO 9001 for Successful QMS in Medical Device Industries - Webinar By GlobalCompliancePanel ... closely compliant with FDA's Quality System Requirements under 21CFR 820. 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. Why should you attend: International interest in certified quality systems is increasing. A Many foreign countries are now requesting medical  more...

HIPAA Business Associates How the regulations have changed and what you need to do for compliance now - Webinar By GCPanel ...dience will learn how business associates are now handled under the law and the proposed regulations and what has changed from the old rules. * The suggested and required content for a compliant business associate agreement will be presented. * Issues of how to assign liability and costs in the event of a breach will be discussed. * Current BAs will learn what they have to do to  more...

HIPAA Breach Notification What to do to prevent breaches and what to do when they happen to you - Webinar By GCPanel ...ul neglect" that begin at $10, 000. * We'll help you understand what isn't a breach and under what circumstances you don't have to consider breach notification. * You'll find out how to report the smaller breaches (less than 500 individuals), as required, within 60 days of the end of each year. * You'll know why you want to avoid a breach involving more than 500 individuals a  more...

Developing the Risk Management Plan - Webinar By GlobalCompliancePanel ...cturing activities are located in different areas and are under different management structures, the Risk Management Plan must document the divided responsibilities and activities. The plan must cover all phases of the product lifecycle risk management activities. This presentation will discuss how to accomplish risk management planning in divided management structures. Why you should  more...

Meet FDA Expectations for a Tougher Supplier Audit Program - Webinar By GlobalCompliancePanel ...ul, results driven actions that addresses and resolve any underlying compliance issues or product problems are increasing among regulatory agencies worldwide. To meet the new regulatory climate and be competitive, companies need to reevaluate their vendors and the methods used in selecting, evaluating, auditing, retaining or cutting adrift such regulatory "partners". Why you should attend:  more...

Change Control -- Your Companys GMP Weak Point - Webinar By GlobalCompliancePanel ...ntropy". Proper change control is required to resolve any underlying compliance issues or product problems that are increasingly seen by regulatory agencies and consumers worldwide. To meet this new regulatory climate and be competitive, companies need to continually reevaluate their change control system and its impact on all areas of a companya ™s cGMP activities. Why you should  more...

Tougher US FDA cGMP Compliance Audits - When Youre Not Ready - Webinar by GlobalCompliancePanel ... 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 oversite of new product introductions (and grandfathered product) by means of the 510(k) system. Business continues to "shoot itself in  more...

Validating Excel and Word Applications Documents - Webinar By GlobalCompliancePanel ...(verification and validation) planning steps are expected under the CGMPs and other guidance documents for such apps software? How can these consistently be executed? Where does ISO 14971, ICH Q9, and similar risk management systems come in? This webinar will evaluate the climate that has resulted in this call for change, and flag areas for heightened compliance in V&V planning. It will focus  more...

Complying with HIPAA Security Rules Whats in the rules and how you can most easily prepare for compliance - Webinar By GlobalCom ...s a complaint. If you haven't done whata ™s required under the HIPAA Security Rule, you could be liable for willful neglect penalties that begin at $10, 000 minimum and go up from there. You need to be sure that you have completed an information flow analysis and a risk analysis and put in place the proper protections to secure protected health information, and documented all your policies  more...

How to Prepare and Submit a Bullet Proof 510k and Latest FDA Proposed Changes to the Process - Webinar By GlobalCompliancePanel ...The Special and Abbreviated 510(k) methods were developed under the "New 510(k) Paradigm" to help streamline the 510(k) review process. Product modifications that could significantly affect safety and effectiveness are subject to 510(k) submission requirements under 21 CFR 807 as well as design control requirements under the Quality System (QS) regulation. Under the QS regulation, all Class II  more...

New Changes to HIPAA The latest changes in the regulations and what they mean to you - Webinar By GlobalCompliancePanel ...teleconference will help health information professionals understand what they have to do, and when, and what to keep in mind as they move forward, in order to be prepared for compliance with the new regulations. The teleconference 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  more...

Medical Device Tracking Latest FDA Update and Expectations - Webinar By GlobalCompliancePanel ...d manufacturers to track if they were registered with FDA under section 510 of the act and engaged in the manufacturer of a device if its failure would be reasonably likely to have serious adverse health consequences, and if that device was either a permanently implantable device or a life-sustaining or life-supporting device used outside a device user facility. Section 519(e), as revised by  more...

How to Prevent or Handle Protocol Deviations and Violations to be GCP and Regulatory Compliant - Webinar By GlobalCompliancePane ...under what circumstances, when the protocol is not followed (PNF) and why this is of particular significance. Covered, will be how a protocol deviation with the least significant effect where there is no substantive effect on the risks to research participants, no substantial effect of the value or integrity of the data, and did not result from willful or knowing misconduct on the part of  more...

101 cGMP To-Do List for 2011 - Webinar By GlobalCompliancePanel ...response requirements. In short, all regulatory areas are under evaluation by the FDA, and need to be revisited by a company's QA/ RA and its senior management. There is "no business as usual". This change in focus has a major impact on interpretation of individual compliance objectives, cGMP objectives, and measurements of success. Recent negative publicity on pharmaceuticals, devices, as well  more...

Audit Committee Responsibilities for Internal Controls - Webinar By GlobalCompliancePanel Overview: With the advent of the Sarbanes-Oxley Act, audit committees are under increased scrutiny for helping management set the tone at the top and ensuring internal controls are documented and tested. As a matter of fact, the Audit Committee has the PRIMARY responsibility for oversight of internal controls. One thing audit committee member should expect is to have a clear understanding of  more...

ISO 13485 as a Quality Management System for Medical Devices - Webinar By GlobalCompliancePanel ...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 certified to ISO 13485: 2003 will  more...

Basics of OTC Drug Labeling Compliance - Webinar By GlobalCompliancePanel ...understand FDA requirements for OTC Drug labeling and compliance. OTC Monographs and their importance to OTC Drug marketing in the U. S. will also be covered. Why should you attend: Anyone who wants to market OTC drugs in the U. S.A. and assure that they're labeled properly with appropriate claims will benefit from this program/ webinar. It will provide background for OTC Drug labeling  more...

Revamping the 510k Clearance Process-Understanding FDAs Proposals - Webinar by GlobalCompliancePanel ... regarding the safety and/ or effectiveness of the device under review. 510(k) submitters would have to provide photographs and design schematics along with detailed device descriptions, which would be available to the public on a revamped 510(k) database. In an attempt to keep up with the rapid pace of innovation in the medical device industry, the FDA plans to issue "Notice to Industry"  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...

Importing and Exporting Medical Devices A Primer on Regulatory Strategy and Requirements ...prior FDA notification or approval. The export provisions under section 802 of the FD&C Act only applies to unapproved devices. Devices that have not been approved or cleared in the U. S. must follow the export provisions of the FD&C Act. Foreign firms that manufacture medical devices and/ or products that emit radiation that are imported into the United States must comply with applicable U. S.  more...