Rules Web-based Seminars

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

New Final HIPAA Amendments New final rules for HIPAA Expand the Scope and Increase Responsibilities This Webinar 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. 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  more...

Portfolio Optimization for Global Drug Development - Webinar By GlobalCompliancePanel Strategic portfolio planning is crucial for developing long-term company strategy. The goal is to meet strategic objectives selecting the "best" portfolio of internal and external drug development programs for funding and balance company resources including money, manpower and manufacturing capacity. Projects could be interdependent, have multiple development scenarios, and are subject to multiple  more...

Contingency Plan for Disasters - Are You Prepared - Webinar By GlobalCompliancePanel Most medical and dental practices are ill prepared for disasters. In addition to the enormous difficulty in returning to business following a disaster, OSHA and HIPAA rules now require that medical and dental practices have a plan of action that will ensure that patient data will not be lost and to also have a plan in place to provide a return to care for its patients. Tuesday, November 8, 2011  more...

Calibration Concepts for Auditors and Reviewers - Webinar By GlobalCompliancePanel This presentation will provide an overview of the rules and assumptions behind the calibration of analytical instruments. We will discuss how external standard, internal standard, and isotope dilution methods are designed, and learn the situations where each technique is the best option.  more...

Effective Hazard Analysis to meet FDA and ISO134852003 Risk Management Requirements - webinar by global compliance panel FDA-GMPs, known as Quality System Regulations (QSRs), and ISO 13485 require Risk Management as integral part of the development life cycle.  more...

W-2s 1099s Independent Contractors Protect Yourself with Proper Classification by TrainHR Understanding proper classification requirements and helping to guide your company through this sensitive and important decision can be one of the most valuable and beneficial services that payroll departments can provide to the organization. Can you be relied upon to make those determinations correctly?  more...

HIPAA and Security Breaches Most frequent issues and causes and trends for future threats by GCP The HIPAA Breach Notification Rule has been in effect since September 23, 2009 and most organizations are not prepared to respond to a breach of PHI and report and document it properly. We will discuss the origins of the rule and how it works, including interactions with other HIPAA rules and penalties for violations  more...

Root Cause Analysis and Documentation Requirements for CAPA - Webinar By GlobalCompliancePanel RCA is a popular topic and many companies realize its importance in correcting problems. However, there is still much confusion and many problems continue to recur. This webinar will use thoughtful discussion, humorous analogies and case studies to distinguish between the true root cause and other common imposters. Emphasis will be placed on realizing system interactions and cultural  more...

HIPAA and Electronic Health Records Meeting the new requirements and new regulations - Webinar By GlobalCompliancePanel The new and proposed HIPAA Privacy and Security regulations will be reviewed and their effects on the use of EHRs will be discussed. The proposed rules call for an ability to make an electronic copy of an individual's protected health information for any information held in an entity's designated record set.  more...

The Controls for Outsourcing Manufacturing and Testing - Webinar By GlobalCompliancePanel The Controls for Outsourcing Manufacturing and Testing" explores the use of outsourcing and how it impacts quality and compliance and the organization as a whole. The primary stakeholders and outsourcing include Quality, Research, Production, Laboratories, Purchasing/ Procurement, Finance, and Senior Management. This webinar will study the outsourcing lifecycle and its impact on the  more...

The Risk to Subject Safety of Not Accurately Reporting Adverse Events - How to Assess and report AEs and SAEs - Webinar By Globa The principal objective in a new drug development program is to assess the benefit / risk ratio. Learn what the risk information is that must be collected, documented and reported accurately.  more...

Device Changes and the 510k - Webinar By GlobalCompliancePanel The majority of medical 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  more...

Human Behavior in Cleanrooms and Controlled Environments - Webinar By GlobalCompliancePanel his live webinar concentrates on identifying good and bad cleanroom behavior. It provides training in cleanroom contaminants and how they are affected by humans. The key benefits of this course are: In-dept understanding of cleanroom contaminants. Achieve satisfactory inspections more easily. Higher assurance of new medical product approvals. Minimize nonconformances.  more...

Product Recalls - Planning and Conducting Food Recall - Webinar By GlobalCompliancePanel Creating an effective Product recall process that will protect both the consumer and company's/ brand's reputation requires careful planning and active involvement of each involved department.  more...

HIPAA Enforcement and Compliance Audits What the auditors want and how to be ready before they call - Webinar By GlobalComplianc ...e prepared already when they do. * Find out what the rules are that you need to comply with and what policies you can adopt that can help you come into compliance. * Learn how the HIPAA rules have changed and how you may need to change how you work to keep up with them. * Learn how having a good compliance process can help you stay compliant more easily. * Find out what  more...

HIPAA Security Policies and Procedures Making them useful and relevant as well as compliant - Webinar By GlobalCompliancePanel ...roper policies and procedures in place as required by the rules and that you have been using them. This teleconference will lay out a structure for the set of policies needed and identify the topic areas that policies should include, making it easier to deal with the dozens of policy details that are required. Areas Covered in the Session: * Find out what are the requirements for  more...

Information Security and Payment Card Rules Protecting Patient Payment Data and Complying with PCI - Webinar By GlobalCompliance ...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 exposures under PCI and HIPAA,  more...

Information Security Risk Analysis Meeting HIPAA Requirements and the Meaningful Use Objective - Webinar By GlobalCompliancePane ... to health information managers. * Find out what the rules are that health care providers must follow, why they are important, and what the penalties are for not complying, including the new penalties for willful neglect of compliance, which begin at $10, 000. * See how the risk analysis requirement for meeting the privacy and security objective of meaningful use, necessary for  more...

Data Security Analysis for Healthcare Providers - Webinar By GlobalCompliancePanel ...y 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 ways to conduct a  more...

Understanding Attribute Acceptance Sampling including Z14 and c0 Plans -- Webinar By GlobalCompliancePanel ...st economical choice * The reasons for the switching rules between normal, reduced, and tightened * The use of the switching rules to help improve your supplier management program * How the switching rules can help you reduce inspection cost The c=0 plans are very popular, since they are based on the notion that everything in the sample should pass inspection. The course  more...

HIPAA Business Associates How the regulations have changed and what you need to do for compliance now - Webinar By GCPanel ...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 required content for a compliant  more...

HIPAA Breach Notification What to do to prevent breaches and what to do when they happen to you - Webinar By GCPanel ...and how it works, including interactions with other HIPAA rules and penalties for violations. * HIPAA Covered Entities and Business Associates need to know where and what information they have, so they can know if there has been a breach, and figure out how serious a breach may be and whom to notify if there is a good chance of harm. Wea ™ll discuss how to know what you have and how  more...

Understanding the Calibration Curve - Webinar By GlobalCompliancePanel ...erview: This presentation will provide an overview of the rules and assumptions behind the calibration of analytical instruments. We will discuss how external standard, internal standard, and isotope dilution methods are designed, and learn the situations where each technique is the best option. Whether you use single point calibration, or linear regression, we will discuss the strengths and  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...

Off-Label Promotion of Drugs - Regulatory Documents Explained - Webinar By GlobalCompliancePanel ...uses of drugs for many years now, but the regulations and rules in recent years were burdensome, and the Department of Health and Human Services Office of the Inspector General (OIG) has been diligently pursuing off-label promotion as a form of Medicare fraud. In February 2008, the FDA issued guidance that permits the dissemination of medical and scientific journal articles. This guidance  more...

XML Training ... 6. XML FAMILY TREE What is XML Family tree? Tree rules XML Ancestor and XML Descendant XML Parent and XML Child XML Sibling 7. ELEMENTS & ATTRIBUTES What is an element? Naming rules for elements Root element What is an attribute? XML Elements vs. Attributes 8. XML NAMESPACES Name conflicts Solving name conflicts XML Namespaces Default namespaces  more...

International Financial Reporting Standards The Basics - Webinar by GlobalCompliancePanel Overview: Where business is concerned the world is becoming a smaller place. Trade boundaries are disappearing, and many companies have subsidiaries around the world. Multi-national corporations needed a simpler way to put together their consolidated financial statements. Already Australia, most of Europe, and many other countries have adopted International Financial Reporting Standards.  more...

Legal Risks in Social Media for Healthcare Providers - Webinar By GlobalCompliancePanel ...edia environment, but most are concerned that the special rules applicable to the healthcare industry prevent or restrict their activities. In fact, the healthcare industry is subject to particularly restrictive rules that impact the manner and method with which they can use social media tools, particularly related to HIPAA and other medical privacy concerns. However, it is possible to pursue a  more...

Preparing for GFSI and other Third Party Audits - Webinar By GlobalCompliancePanel Overview: Preparation and organization are the keys to a successful audit. This session will allow your team to anticipate the auditors needs and result in the facility's ability to achieve the maximum benefit and score from the audit. Why you should attend: More and more customers are requiring GFSI audits such as ISO 22000, BRC and SQF or accepting them in lieu of their own audits.  more...

Using Foreign Trial Data in Your NDA Approval Process - Webinar By GlobalCompliancePanel ...DA approval; * Discuss how FDA is implementing these rules and what you can do to assure compliance; and * Recognize design considerations and requirements for foreign trials Who will benefit: This webinar will provide valuable assistance to all personnel in: Pharmaceutical, Biotechnology, CROs and Research Facilities Conducting Clinical Trials including: * Managers in  more...

Complying with HIPAA Security Rules Whats in the rules and how you can most easily prepare for compliance - Webinar By GlobalCom ...red under the HIPAA Security Rule * Find out how the rules have changed and will continue to change * See the questions you are likely to be asked in a HIPAA Security compliance audit * Learn how to go about developing and implementing your compliance plan * Discover how information flow analysis and risk analysis can make sense of your compliance objectives * Find out  more...

Water System Biofilm Control and Microbial Monitoring Myths - Webinar By GlobalCompliancePanel ...d. You will probably be surprised to learn which of your "rules of thumb" are actually quite wrong! Perhaps you will find out why you are having microbial problems in spite of using supposedly microbial-controlling designs and approaches! Perhaps you will find out that you have been doing costly, useless, and scientifically unjustifiable testing that can be stopped. You probably cannot afford  more...

New Changes to HIPAA The latest changes in the regulations and what they mean to you - Webinar By GlobalCompliancePanel ...es 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 Services and  more...

Japan - Regulatory Filing Requirements and Compliance Processes for Life Sciences - Part I and Part II - Webinar By GlobalCompli ... o Possible License Types * Objectives of the Rules Governing Medicinal Procedures o Market Authorization Holder Overview * Life Science Regulations and the Regulatory Processes in Japan o Pre-Clinical o Conducting Clinical Trials o New Product Registrations & Filings o Post-Marketing Requirements o Pricing &  more...

A Comparison of ICH Q-10 Quality System and the FDAs Quality Systems Approach QSA to the Pharmaceutical GMPs - Webinar By Global ...nting quality concepts rather than focusing on the strict rules of compliance. This webinar will show how to strike a balance between compliance and quality. Areas Covered In the Session: * What are the objectives of ICH-Q10 and the FDA's Quality Systems Approach to Pharmaceutical Good Manufacturing Practices? * What are the similarities and differences between these guidance  more...

Introduction to Operational Risk - Webinar By GlobalCompliancePanel ...discovery * Appreciate the importance of the Federal Rules of Civil Procedure * Grasp why Americaa ™s litigious nature is spreading to its trading partners. * Understand how to mitigate your legal risk PART THREE * Comprehend the importance of the Principle/ Agent problem * Use simple measures to reduce financial crimes. * Grasp that corruption is a way  more...

Defining and Managing Protocol DeviationViolationException - Webinar by GlobalCompliancePanel ...d effectiveness of a treatment, it is imperative that the rules of the trial be followed exactly. If there are Instances of "Protocol Not Followed" (PNF), that could result in a failure to determine safety and effectiveness. That is why eligibility criteria are so strict, and why any PNF or unexpected events need to be reported immediately. Principal investigators in clinical trials are  more...

Ten-Step Process for COTS Computer System Validation - Reduce Time and Cost GlobalCompliancePanel brings a new webinar on the topic of Ten-Step Process for COTS Computer System Validation - Reduce Time and Cost. Webinar will be on April 6, 2010. Webinar will be presented by David Nettleton. This webinar details all of the templates used to create validation documentation, usually saving two-thirds of the time and costs. The 10-step risk-based approach to COTS software  more...

Specification Development GlobalCompliancePanel brings a new webinar on the topic of Specification Development. Webinar will be on March 23, 2010. Webinar will be presented by Melinda Allen. A good specification not only defines the product and process being purchased by the customer, but also serves as an extension of the purchasing contract. Specifications are a customers greatest tool for ensuring products received  more...

Design Planning and conducting Effective audits GlobalCompliancePanel brings a new webinar on the topic of Design, Planning and conducting Effective audits. Webinar will be on March 23, 2010. Webinar will be presented by Mark Roberts. Internal quality system audits should be viewed as an improvement tool. Too often due they have a negative connotation and are viewed as a necessary evil. Effective audits can comply with the regulations and  more...

21 CFR Part 11 Auditing for Part 11 Compliance GlobalCompliancePanel brings a new webinar for the medical devices industry professionals. Webinar will be on March 18, 2010. Webinar will be presented by Jasmin NUHIC. 21 CFR Part 11 is FDA regulation for electronic signatures and electronic records. It started by the pharma - it is a good regulation for medical and pharma companies but it is also a good guideline for other industries.  more...

Update on Unique Device Identifier for Device Manufacturers FDA is reconsidering whether some form of unique device identification (UDI) is warranted for medical devices, given the potential of UDI to help reduce medical errors, facilitate recalls, and other issues identified from above but also improve inventory control, improve reimbursement, and reduce product counterfeiting. Once your device is approved, ongoing regulatory requirements fall largely  more...

PCI Data Breaches What happened What may have prevented it What if it happens to you If your organization is struggling to meet compliance requirements for PCI, you're in good company. Unfortunately, in this case there is no safety in numbers. Criminals do not necessarily attack big companies; they go after whatever is easy. The cost of responding to a breach is getting more expensive each year. In this webinar you will learn about the current threat environment, how some of  more...

New Requirements for the Medical Device Directive MDD GlobalCompliancePanel brings a new webinar on the topic of New Requirements for the Medical Device Directive (MDD) Webinar will be on March 11, 2010. Webinar will be presented by Albert Cefalo. Mr. Cefalo has a BS degree from Franklin Pierce College and a Graduate certificate in RA from Northeastern University. For the last 21 years he has been employed by Analogic Corporation. During his career  more...

Curtailing Microbial Excursions and Investigations in Pharmaceutical Water Systems GlobalCompliancePanel brings a new webinar on the topic of Curtailing Microbial Excursions and Investigations in Pharmaceutical Water Systems. Webinar will be on March 11, 2010. Webinar will be presented by Teri C. Soli. Mr. Soli has 25 years of diverse "Big Pharma" operating company experience. During his 30 year career he has lectured extensively at conferences, authored numerous papers and  more...

Excel Spreadsheet Validation To Eliminate 483s GlobalCompliancePanel brings a new webinar on the topic of Excel Spreadsheet Validation To Eliminate 483s. Webinar will be on March 10, 2010. Webinar will be presented by David Nettleton. Mr. Nettleton is an FDA Compliance Specialist for 21 CFR Part 11, HIPAA, and Computer System Validation. His latest book is "Risk Based Software Validation - Ten easy Steps" that relates to the development,  more...

Foreign Material Control GlobalCompliancePanel brings a new webinar on the topic of Foreign Material Control. Webinar will be on March 9, 2010. Webinar will be presented by Melinda Allen. Ms. Allen is a Food Safety and Quality Consultant in the Food Industry. Melinda has had a long and dedicated career of Quality Assurance and Food Safety leadership with companies such as YUM Brands and Quiznos.  more...

Validating Radiation Sterilization for medical device industries GlobalCompliancePanel brings a new webinar on the topic of Validating Radiation Sterilization for medical device industries. Webinar will be on March 9, 2010. Webinar will be presented by Mark Roberts. Mr. Roberts is the head of Roberts Consulting and Engineering (RCE), a consulting firm specializing in quality system and sterility assurance compliance. He was previously the Manager for the  more...

The 510k Submission Requirements Contents and Option GlobalCompliancePanel brings a new webinar on the topic of The 510(k) Submission: Requirements, Contents, and Option. Webinar will be on March 4, 2010. Webinar will be presented by Jeff Kasoff. Mr. Kasoff is the Director of Regulatory Affairs at Life-Tech, Inc., a leading manufacturer of consumables and instrumentation in the urodynamic and pain management fields. Jeff is responsible for  more...

Business, Project and Compliance Risk GlobalCompliancePanel brings a new webinar on the topic of Business, Project and Compliance Risk. Webinar will be on March 2, 2010. Webinar will be presented by Edwin L Bills. Mr. Bills has held a number of quality and regulatory affairs positions. Mr. Bills is ASQ Certified as Quality Engineer, Quality Auditor, and as Manager of Quality/ Organizational Improvement.  more...