The Act Web-based Seminars

LEGAL LANDMINES EXEMPT VS NON-EXEMPT CLASSIFICATION ISSUES Dona ™t get caught by the Department of Labor for misclassification of your employees! Attend this informative and engaging on-line live webinar today to learn key methods to avoid FLSA liability for misclassification of employees. This webinar will be presented by an experienced employment attorney who will provide an in-depth summary of what you need to know and answer all your FLSA and  more...

Top Tips To Prevent Workplace Violence in your Workplace Protect Your Workplace Today! A one-hour live workplace violence training audio conference webinar that is helpful for both private as well as public employers. It is also fully compliant with the New York State Workplace Prevention Act that requires workplace violence prevention training for all public employers. This Workplace Violence Prevention Training Audio Conference Webinar will  more...

AVOID LEGAL PITFALLS OF DRAFTING JOB DESCRIPTIONS Job Descriptions are legal documents that can and often are used in a court of law as evidence against an employer. Learn how to avoid the legal pitfalls of drafting these legal documents and best practices for drafting all of your job descriptions. This on-line live webinar will help you avoid legal problems related to the Americans with Disabilities Act, employment discrimination and  more...

Dietary Supplement Regulatory Compliance in the United States Labeling Product Claims Updates from the FDA - Webinar By GlobalC This 90 minute live, interactive webinar will review the dietary supplement regulations and discuss how to verify that your products are compliant, while citing differences with food and drug regulations. We will also cover what qualifies a material as a dietary ingredient, considerations for manufacturers and distributors, requirements for compliant labeling and acceptable marketing claims. An  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...

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...

Winning Presentation Skills Put Power Punch and Pizzazz into Your Presentations by TrainHR If you want to project poise and professionalism, captivate your listeners, persuade people to act on what you say and develop comfort and confidence this session is for you.  more...

Adverse Event Reporting for Dietary Supplements and OTC Drugs - Webinar By GlobalCompliancePanel Since passage of the Dietary Supplement & Nonprescription Drug Consumer Protection Act in Dec. 2007, FDA requires reporting of serious adverse events for dietary supplements and OTC drugs. Manufacturers and importers of products in these categories often have questions about what constitutes a serious adverse event and about Adverse Event reporting requirements that this Webinar will be able to  more...

Data Security Analysis for Healthcare Providers - Webinar By GlobalCompliancePanel Overview: Data Security Analysis for Healthcare Providers: The "meaningful use" rules relating to the adoption of Electronic Medical Records require regular assessment of data security risks. HIPAA re-contains similar requirements. However, many healthcare providers fail to take the necessary steps to analyze their security risks or assess their vulnerabilities. This presentation would address  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...

HIPAA Business Associates How the regulations have changed and what you need to do for compliance now - Webinar By GCPanel Overview: HIPAA Business Associate rules have changed in fundamental ways, with new responsibilities and obligations for HIPAA BAs. The session will provide attendees the following tools, benefits, and solutions: * The audience 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  more...

HIPAA Breach Notification What to do to prevent breaches and what to do when they happen to you - Webinar By GCPanel Overview: The new HIPAA Breach Notification Rule required by the HITECH Act within the American Recovery and Reinvestment Act of 2009 went into effect September 23, 2009, requiring all HIPAA covered entities and business associates to follow a number of steps to be in compliance. * The HIPAA Breach Notification Rule has been in effect since September 23, 2009 and most organizations are not  more...

Food Drug Cosmetic Act Implementing Regulations Major New Laws - An Overview - Webinar By GlobalCompliancePanel Overview: Food, Drug, and Cosmetic Act history basics will be covered as will implementing FDA regulations relevant to the Food, Dietary Supplement and OTC Drug industries that have followed. Some more recent major new regulations such as the Dietary Supplement Health & Education Act (DSHEA), the Bioterrorism Act, and the Food Safety Modernization Act will also be covered. Areas Covered In  more...

FDAs Proposed Rule Regarding Device Establishment Registration and Listing and How to Register and List - Webinar By GlobalCompl ...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 Rule that would amend its regulations regarding medical device establishment registration and device listing (the Proposed Rule).The Proposed Rule contains four types of proposed changes to FDA's device establishment registration and device listing  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...

Utilizing Good Requirements as a Foundation for the Effective Validation of PDMA-related Computerized Systems - Webinar By Globa Overview: Computerized systems can be a boon to the Sales and Marketing group of an organization that falls within FDA regulatory authority. By automating, tracking, and reporting on thousands of sample product transactions, such systems can provide a powerful mechanism for compliance to the requirements of the Prescription Drug Marketing Act (PDMA), while accomplishing this with a manageable  more...

New Changes to HIPAA The latest changes in the regulations and what they mean to you - Webinar By GlobalCompliancePanel Overview: New regulations modifying the HIPAA Privacy and Security Regulations have been proposed and/ or finalized to meet the privacy and security mandates within the HITECH Act in the American Recovery and Reinvestment Act of 2009. New requirements for business associates of HIPAA covered entities and requirements to notify individuals in the event of a breach are only two of the many areas  more...

Medical Device Tracking Latest FDA Update and Expectations - Webinar By GlobalCompliancePanel ...ack 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 FDAMA, states the  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...

Validation and Use of Excel Spreadsheets in FDA Regulated Environments - Webinar by GlobalCompliancePanel Excel Applications are widely used in laboratories, offices and manufacturing e. g., for data capture, data manipulation and report generation. Regulations such as HIPAA, Sarbanes Oxley Act and FDA's GxP and 21 CFR Part 11 require users of software and computer systems to demonstrate and document data accuracy, integrity and confidentiality. Out-of-the box Excel has not been designed for  more...

GMP Expectations for Products Used in Early Phase IND Studies - Webinar by GlobalCompliancePanel FDA issued a guidance document covering GMP requirements for Phase 1 products. These guidelines remove some of the problems that are encountered with early phase products and are in addition to those that cover the CMC sections for IND submissions at Phase 1. Although the guidance appears to remove the need to follow GMPs for Phase 1 products, the need to follow GMPs is still present in the  more...

Auditing API Manufacturers and Suppliers - Webinar by GlobalCompliancePanel This program will focus on the basics needed to perform an API audit. Performing an audit is not simply an act of visiting a firm and checking off a list of questions. Auditing API producers and suppliers is an important part of GMP compliance programs. Identifying what approach or process to use is examined and the tools to utilize during an audit is also discussed. Audits at best are  more...

Combination Products FDAs Proposed Rule for GMP Requirements and Introduction and Expectations for Combo Products - Webinar by G What is a combination product? What are some examples of combination products? How are combination products assigned for review? Where can I find guidance for how master files can be used in the submission of information relevant to my combination product Determine which Center will review my combination or non-combination product? These topics and more will be addressed during this Webinar,  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...

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 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. 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  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...

Auditing a Process-based System - Compliance Training Seminar by GlobalCompliancePanel There are a number of reasons for someone to attend this webinar. First and foremost they will gain an understanding of the process approach. The process approach requires management to identify all processes of the QMS, their sequence and interaction. They must ensure the effectiveness of all processes and the availability of needed resources, and monitor, measure, analyze and improve them. They  more...

ACT Everyday ...ting. Included in the 2. 5 hour curriculum are how to use the ACT! calendar, task list, email and letter mail merge functions, dynamic groups, company records and how to customize dashboards for a snapshot view of your action items and sales and marketing metrics. You'll also learn how to gain insight on your contacts via the Web Marketing tab which gives you access to all social media sites,  more...

Improving Communication This course shows participants how to read other people and to see how others interpret their behaviors. It leaves them with a gut-level appreciation for the needs of their co-workers. Ultimately, the course helps participants adapt their communication styles in a way that creates an enduring working alliance among those you communicate with. This program is designed to help participants:  more...