What Web-based Seminars

Hiring Plan Webinar HIRING PLAN | Thursday, November 10, 2011 | 2: 00 PM a 5: 00 PM CST Led by Alicia Marie How do you know when it is time to hire? What role is the right one? Identify a strategy for building your organization as well as a hiring process for identifying talent. Save time, money and the headache of a bad hire. Register Here:  more...

Inspired Goals Webinar YOU WILL LEARN: a The top three reasons why people dona ™t set goals a How to start fresh and complete past goals a The process of focus and attention a Goal setting tips a The language of goal setting a Strategy for what will likely stop you from achieving your goals a How to set goals that inspire and motivate a How to embrace failure and  more...

Interactive Analytics This Free Webinar is designed for Business analysts and developers to become familiar with using BIRT to design and develop Interactve Financial Dashboards and BI Applications with rich data visualizations. BIRT is a top level project within Eclipse and is the fastest growing open source reporting technology with over 5 million dowloads in the past 2 years. Actuate founded and continues to co-lead  more...

Mastering Microsoft Excel PivotTables Turn the tables on data analysis [WEBINAR] ... analysis tools - PivotTables ®. Youa ™ll learn what PivotTables are, how they work and how YOU can tailor them to fill your needs. Herea ™s a small sample of what youa ™ll learn: a how to take advantage of the calculation power of PivotTables. a how to create complex data comparisons. a how to quickly drill-down to specific sub-sets of data without  more...

Spiritual Practice Path Bob Dylan has a song lyric that says 'You gonna have to serve somebody'; as in practice some form of spiritual worship. That may or may not be true, but it's definitely true that anyone interested in personal growth and development has to take the chance now and then to stop and examine their beliefs and practices. We're not going to discard anything here, over 4 weeks (with a 2 month check in)  more...

Listening for Tech Entrepreneurs ...steeped in their product that they don't pay attention to what is happening around them, then they wonder why they're not getting funding, a market, or customers. A major factor in this challenge is the lack of well developed listening skills. Many tech entrepreneurs have no idea how they listen, let alone if their listening habits are appropriate for the situation they are in. This  more...

LABOR RELATIONS TRAINING ...ivate webinar solely for your management employees. What you will learn: Effective Management in a Represented Environment Overview of Collective Bargaining Agreements Effective Strategies for Engaging in Progressive Discipline Methods to Communicate with Represented Employees Managing Conflicts in the Workplace  more...

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...

From Hiring To Firing What Every Manager Needs to Know FMLA, 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 To Prevent Workplace Violence in your Workplace ... Conference Webinar will provide you with a definition of what constitutes workplace violence and examples of who can engage in workplace violence. It teaches you to recognize the warning signs that can lead to workplace violence and provides techniques and strategies to avoid violence in the workplace. This Workplace Violence Prevention Training makes you aware of situations that may pose a  more...

Employee Handbooks Dos and Donts ... employers can make that reek havoc for employers. Learn what policies must be in your employee handbook as well as phrases and terms that you should never use in such a handbook. This informative seminar will outline for you the dos and dona ™ts of drafting an effective well-written employee handbook. It will examine what the courts have said on these issues and provide practical tips  more...

Top Tips For Managers to Prevent Harassment in your Workplace ...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 environment  more...

TOP 10 TIPS FOR CREATING A BLOGGING AND SOCIAL MEDIA POLICY ... Social Media Policy a Doa ™s and Dona ™ts For What Should Be Included in the Policy a Blogger Beware! The Dangers of Failing to Draft Such a Policy a Tips For Managing the Risks of Social Media Technology a Revising Other Policies to Cover Social Media Issues a Training your Employees on your Social Media Policy Date: October 20, 2010 Time: 1:  more...

HIRING DOS AND DONTS ...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. Learn how to avoid claims of implied contract that lead to breach of  more...

Tips To Avoid Liability When Terminating Employees This live Webinar is a must for all employers. Learn how to protect your company and yourself in this workplace law guide to terminating employees that provides some top tips for avoiding liability. Nothing causes more problems for employers than terminating an employee. Attend this informative one-hour seminar to learn how to avoid the top mistakes that employers often make when terminating  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...

Customer Service Training This customer service training class teaches students the basics of customer service. Students will learn how to develop and maintain a positive attitude, show extra attentiveness to customers, use customer-friendly language, and deal effectively with customer complaints and problems. Finally, students learn how to build rapport with customers, interpret non-verbal communication skills, provide  more...

MySQL Development Training This MySQL Training course teaches how to develop database applications on MySQL, using various Database Manipulation Language (DML) statements, MySQL Stored Procedures, Triggers, Views, and Information Schema. Students will be able to use what they learn in this class to create complex queries and reports, even aggregate results.  more...

MOC 8824 - Sales Order Processing in Microsoft Dynamics GP 10.0 This Microsoft Dynamics GP Sales Order Processing class explores the accounting cycle and the processes required to enter and ship sales orders. This class shows you how to easily manage the life-cycle of your customer ' s order from the initial quote to the shipment documentation and final invoicing. You learn how to perform additional functions setting up process holds for quality assurance and  more...

Java EE Seminar for Managers ...ation of the Java Platform, Enterprise Edition (Java EE): what sorts of software are created with Java EE; how software is developed for this platform; how it is deployed and put into production; how it can be administered. The course is designed specifically for non-programmers -- analysts, managers, technical writers, and anyone who desires a good conceptual understanding of Java EE while  more...

Introduction to Internet Technologies You use the Internet regularly, for both work and personal purposes. But now, for various reasons, you want to learn about the technical side of the Internet: What constitutes the Internet? How is a website developed? What are the emerging trends and technologies on the Internet? In this course, you will examine the technical aspects of the Internet.  more...

Diversity and Cross-Cultural Business Communication Training ...pervisors, team leaders and managers. Students will learn what diversity is and how it influences their relationships with others, and how to differentiate between-and overcome-stereotyping, prejudice, and discrimination. Students learn how communication skills help in managing a diverse workforce and how diversity influences relationships between co-workers.The second day focuses on  more...

SharePoint 2007 Governance Training This SharePoint training course covers the ins and outs of governance in general as well as common taxonomies. You will review what a Governance plan is made up of, as well as learn how to create a training plan, SharePoint service offerings and how to follow through with enforcing the plans. We will review Information Architecture and why it is important.We will take a look at each level in  more...

Certified Eco Green Consultant Training Program GoEco Certified had developed the nations best & most comprehensive Certified Eco Consultant Training Program to help future Eco Consultants provide a valuable service within their community helping Homes/ Businesses GO GREEN! Green Consulting is a rewarding carrer that can be either part time or full time. All of the Eco Consultants are actual Certified Eco Consultants in the field doing exactly  more...

Measuring Performance of Your Global Procurement Organization How to Shape Behaviours in Global Purchasing ...Manufacturing Enterprise Seriesa webinar include: - What is the best way to organize the procurement function when so many items are sourced globally? - How to define purchasing behaviors to better leverage global supply-chain opportunities. - Ideas for building a Global Procurement metrics dashboard that provides visibility to what is really important. - Components of Total Cost  more...

How to Dramatically Improve the Quality of Your Shipment ForecastsTechniques to Improve Forecast Inputs ...and projected magnitude of customer shipments. 3. Learn what future information goes into a a Market Requirements Definitiona (MRD) document and how it should be created and maintained. 4. Learn how to better use past shipment data to more closely predict future shipments. 5. Learn the importance of acquiring current (or real-time), data in order to make appropriate short-term forecast  more...

Understanding Improving Yields Scrap Rework Scrap and yield are different measurements that tell us different things about our production processes. Measuring and monitoring them precisely (and individually) is an important component of any process improvement initiative. If these values get comingled in the measurement procedures, underlying root cause analysis is certain to result. This FREE 1-hour webinar presents the CORRECT  more...

The Most Important Metrics For Measuring Supply Chain Performance ... A core question on the mind of many executives is: a What are the BEST metrics for measuring global supply chain performance and which metrics will lead my organization to focus on what is TRULY important?a Common supply chain metrics observed in many manufacturing companies include: a Inventory Turns or Days-of-Supplya metrics that describe the efficiency or inventory and use of  more...

How to Conduct an Effective Monthly Variance Review Meeting ...repare for and conduct their variance review meetings and what information they bring to the meetings. Further, we will present ideas for engaging all participants in these meetings as well as how to set expectations for follow-up activities. This webinar is one of our most popular because the tools, procedures and techniques presented are so easy to implement and yield such large returns in  more...

Constructing a Component Criticality Matrix A Better Way to Identify Important Components ...t webinar has three important objectives: 1. To learn what a Component Criticality Matrix is and how to construct one. 2. To learn how to interpret the results of a Component Criticality Matrix and how to connect interpretations with planning and ordering actions. 3. To understand the limitations of the Component Criticality Matrix and how some parts can be nearly impossible to  more...

Should Under-Utilized Capacity Costs Be Included in Work Center Burden Rates ...thus increasing your companya ™s gross margins. But what happens to product gross margin when sales drop and factory UNDER-UTILIZATION increases? Plant, property, equipment and people do not go away just because utilization drops. And yet, as utilization drops, gross margins also drop, which may suggest a product PRICE increase is in order except if prices are increased, wona ™t  more...

A Better Method for Rationalizing Capital investmentsTools for Calculating REAL Investment Value It is an interesting observation that manufacturers continue to struggle with the best way to rationalize new investments in capital equipment. Interestingly enough, this struggle is often the result of failed cost accounting systems and methods. It is these systems that fail to provide accurate information that ultimately allow an investment to be appropriately modeled within the context of the  more...

How to Calculate the Impact on Total Factory Costs from a One Percent Change in Planned Load ...uring companies to grow and sustain success, knowledge of what a 1% change in volume does to utilization and incremental fixed costs is essential. This 1-hour FREE webinar will present some interesting thoughts and techniques, specifically focusing on how your company can come to an understanding of what a 1% change in planned load means to profitability and enterprise value. We will  more...

How The Manufacturing Industry Can Save Americas Economy America's economy is in trouble and only the manufacturing sector can save it! It is clear that Americaa ™s competitiveness on the global economic stage is diminishing. This is more than a feeling. It is supported by industrial productivity data, product ramp-up analyses, commercial employment statistics, comparative trade balance values and international industrial liquidity data. After  more...

New Final HIPAA Amendments New final rules for HIPAA Expand the Scope and Increase Responsibilities ...nar 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 Covered In  more...

FDAs 21 CFR 11 Add-On Inspections - Recent Updates - Webinar By GlobalCompliancePanel This presentation will cover the scope, status and results of the surveillance inspections and what they may mean for the future of 21 CFR Part 11. This will enable you to determine whether your company is subject to the most common violations so you can take action to have a better inspection outcome. Tuesday, February 14, 2012 10: 00 AM PST | 01: 00 PM EST  more...

21 CFR Part 11 and Annex 11 What you Need to Know to Pass the New Regulatory Audits - Webinar GlobalCompliancePanel This webinar details both regulations and provides details for implementing computerized systems. Tuesday, March 6, 2012 10: 00 AM PST | 01: 00 PM EST  more...

Dietary Supplement Regulatory Compliance in the United States Labeling Product Claims Updates from the FDA - Webinar By GlobalC ...rences 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 update on FDAa ™s draft guidance for New Dietary Ingredients and an overview of the Dietary Supplement Labeling Act (both introduced in 2011) will also be  more...

FDA 483 Observations in the Laboratory What went wrong How can they be avoided - Webinar GlobalCompliancePanel In order to proactively address areas of concern to the FDA and other regulators, All units within each pharmaceutical firm should review recent regulatory observations and proactively establish programs or systems to address the regulatory concerns. Tuesday, January 10, 2012 10: 00 AM PST | 01: 00 PM EST  more...

Dental Digital Radiography - Better for the Patient and the Practice - Webinar By mentorhealth This webinar is for those wondering what digital radiography is, how it differs from film, how it works, and how it impacts the dental office. And for those unsure which system to purchase and how to incorporate it into Their practice? It is also for those who are using it and learn how to use it more effectively. Tuesday, December 20, 2011 10: 00 AM PST | 01: 00 PM EST  more...

How to Survive a DEA Inspection Series For a Research Facility - Webinar By mentorhealth The training will cover DEA record-keeping and effective security that DEA registrant must comply with when handling controlled substances. It covers elements of what occurs during an unannounced inspection and the auditing methods. Thursday, December 1, 2011 10: 00 AM PST | 01: 00 PM EST  more...

What is New in Ultrasonics Exploring Piezoelectric Technology - Webinar By mentorhealth ...what "the Piezo" is all about? What makes it so different from "the Cavitron"? This course is designed to examine the unique capabilities of piezoelectric ultrasonics and the role micro-ultrasonics play in contemporary periodontal therapeutics. Discussion of hand scaling versus power scaling will be explored, as well as an overview of the various piezoelectric ultrasonic devices that are on  more...

Best Practices in Key Financial Metrics - Webinar By mentorhealth Hospital executives have a hard job to do! In attempting to create and achieve an effective strategic plan, there is a great need to determine specific outcomes that will be consistent with the organization's underlying mission, broad policies, culture and accepted industry normsa .But what exactly does this mean? What are the elements that will be instantly recognizable as "a" or "the" key  more...

Troubleshooting Ethylene Oxide EO Processes - Webinar By GlobalCompliancePanel Not every parameter in the EO sterilization process in critical for the determination of the SAL. This presentation will outline the various parameters and what actions should be taken when they are not compliant to the process specification. Thursday, December 15, 2011 10: 00 AM PST | 01: 00 PM EST  more...

Key Aspects of the Trial Master File and How to Pass FDA Inspection - Webinar By GlobalCompliancePanel This presentation will help with preparing the site and the study team with how to successfully prepare for an audit, how to identify risk of noncompliance, what to do before, during and after an audit. All these are done with the primary goal in mind: getting no audit findings. Thursday, November 3, 2011 10: 00 AM PDT | 01: 00 PM EDT  more...

21 CFR Part 11 and Annex 11 What you Need to Know to Pass the New Regulatory Audits - Webinar By GlobalCompliancePanel This webinar details both regulations and provides details for implementing computerized systems. Tuesday, December 6, 2011 10: 00 AM PST | 01: 00 PM EST  more...

A Practical Look at Discipline and Termination - Webinar By TrainHR ...l also explore some best practices for deciding: when and what kind of discipline to use, how to document it, and how to implement it. Importantly, you'll also look at how your own conduct can contribute to performance management problems on your teams. In addition, you'll learn about the need to view and position discipline as a positive tool rather than as an oppressive or punitive one. The  more...

Calculating Overtime Correctly - Webinar By TrainHR ...rtime is simple, right? Ita ™s just time and a half! What is so tough about that? Not so fast. Overtime is based on the regular rate of pay, and calculating the regular rate of pay is more complex than it appears. Whata ™s included in the calculation? The reasonable cost of meals, lodging, nondiscretionary bonuses, on-call pay, shift differentials, cash benefit payments from  more...

Privacy as a cultural issue what it means to HR or to Corporate Counsels or to Hospital Administrators - Webinar By mentorhealth Risks of HIPAA violations pale to the risks to employees, employers, and communities regarding conflicting loyalties, symptomatic over-valuation of privacy, and a clear understanding of where privacy and confidentiality need to be bartered for higher priorities of individual safety. Wednesday, October 26, 2011 10: 00 AM PDT | 01: 00 PM EDT  more...

How to Prevent or Handle Protocol Deviations and Violations to be GCP and Regulatory Compliant - Webinar By GlobalCompliancePan ...what happens, and 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  more...

Introduction to Contamination Control Master Plans - By GlobalCompliancePanel ...ants for your products. Areas Covered in the Session: What is a CCMP and how is it valuable to my company? What topics are covered in the CCMP and to what extent? How is the CCMP controlled and updated? How is the CCMP implemented? Who contributes to the CCMP? Who Will Benefit: QA personnel Regulatory personnel Operations managers Microbiologists R&D Scientists Validation  more...

Designing an Effective Cleaning Validation in todays Regulatory Environment - Webinar By GlobalCompliancePanel This webinar concentrates on designing effective cleaning validation studies. Key benefits of this seminar include: Learn what steps should be followed. Identify critical parts of cleaning validation process. Achieve satisfactory inspections. Higher assurance of new medical product approvals. Minimize nonconformances. Reduce rates of batch rework and rejections. Avoid product recalls.  more...

How to Survive a DEA Inspection Series For Analytical Labs and Researchers - Webinar By GlobalCompliancePanel The training will cover DEA record-keeping and effective security that DEA registrant must comply with when handling controlled substances. It covers elements of what occurs during an unannounced inspection and the auditing methods.  more...

How to Survive a DEA Inspection Series Controlled Substances and Hospitals - Webinar By GlobalCompliancePanel This training will cover several recommendations to improve the hospital's Due Diligence when administering and dispensing narcotic drugs in a hospital setting and what steps to take to detect and prevent the illicit use or diversion.  more...

Excel Spreadsheet Validation to Eliminate 483 - Webinar By GlobalCompliancePanel This interactive webinar provides explicit details and live demonstration followed by a collaborative workshop that explains how to configure and validate a GxP compliant spreadsheet application. What makes this session unique is the combination of step-by-step instructions and the hands on workings of each participant. Bring your laptop and use Excel for yo  more...

SAP FICO Online Competency Development Training program ...t process) During the Training: Video 1 a Explains what our training program consists of Video 2 - Overview Video of the course (Explained by the Trainer)-> Video 3 - What Happens after you Signup ? Video 4 a During the training process - Video 5 - Instructor-led Online Training Benefits a Click here Video 6 a List of FICO training materials we share a Click here,  more...

JAVA J2EE JEE Professional Role Based Training from Zaran Tech ...t process) During the Training: Video 1 a Explains what our training program consists of Video 2 a What happens after you Signup? - Video 3 - During the Training Process - Video 4 a How we use Googledocs to share documents/ materials - Video 5 - Instructor-led Online Training Benefits a Click here After the Training Process: Video a After the training process explained  more...

SAP BOBJ with BW integration Online Competency Development Training program ...Video 1 - SAP BOBJ Training program Explained, Video 2 - What Happens after you Signup ? Video 3 a During the training process - Video 4 - Instructor-led Online Training Benefits a Click here Video 5 - Demo Video Recording (From the Trainer) - After the Training Process: Video a After the training process explained a Click here Video - Our 6-step training to placement process  more...

Business Analyst Competency Development Program ...t process) During the Training: Video 1 a Explains what our training program consists of Video 2 a What happens after you Signup? - Video 3 - During the Training Process - Video 4 a How we use Googledocs to share documents/ materials - Video 5 - Instructor-led Online Training Benefits a Click here Video 6 a BA Materials we share during Training a Click here, After the  more...

How to Survive a DEA Inspection Series Only Manufacturers and Distributors - Webinar By GlobalCompliancePanel This training will cover DEA record-keeping and security requirements that a registrant must comply with when handling controlled substances and regulated chemicals. It covers elements of what occurs during unannounced DEA Diversion inspection and the auditing of all controlled substances and regulated chemicals. As a firm handling those products, you will get a better understanding of what is  more...

FDA Inspections - Dos Donts - webinars by gcp The purpose of the FDA inspection is a verification activity that should demonstrate to the regulatory agency and provide assurance that products consistently meet quality expectations and that your company is operating in a consistent and compliant state of control.  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...

Controlling Workers Comp Injuries As Your Workforce Ages ...ter understanding of the older worker at work so you know what to expect as our workforce ages. Older employees now constitute a larger segment of the workforce than in previous years. In general, for most states up to 20% of workersa ™ in most industries are 55 or older. It is projected by the BLS (Bureau of Labor Statistics) that by 2016, almost 55 million US workers will be 50 or  more...

FDA Inspections - Dos Donts The purpose of the FDA inspection is a verification activity that should demonstrate to the regulatory agency and provide assurance that products consistently meet quality expectations and that your company is operating in a consistent and compliant state of control.  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...

Using Statistics in Compensation BY Train HR This webinar will address the math behind pay program design and administration, from the design of pay structures through the analysis of pay survey data that enables practitioners to create and analyze pay ranges, pay survey data, individual and group pay rates, and other elements of a compensation program.  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...

Good Deviation Practice what you need to know-BY GCP This course explores the deviation and CAPA processes and best practices for both. It shows how to avoid pitfalls and minimize regulatory scrutiny by having a robust deviation/ CAPA system and thorough investigations  more...

How FDA Trains its Investigators to Review CAPA and What You Should Do to Prepare by GCP This webinar will provide valuable assistance to all companies that market in the U. S., since they are by definition subject to FDA regulation, in the Medical Device, Diagnostic, Pharmaceutical, and Biologics fields.  more...

Lyophilization What you Need to Know Validation and Regulatory Approaches by gcp This course explores the science and art of lyophilization and discusses how the lyophilization cycle and process is developed and validated, along with the regulatory requirements for lyophilization.  more...

21 CFR Part 11 and Annex 11 What you Need to Know to Pass the New Regulatory Audits This webinar details both regulations and provides details for implementing computerized systems  more...

The Law and Psychology of Mental Health Issues at Work Substance Abuse Depression and the Bermuda Triangle of the ADA the FMLA a ...tersect When do conduct problems become mental illness? What do you say to a depressed employee? What protection do alcoholics and substance abusers have under the A. D. A. How to handle threats and other disruptive behavior The 5 biggest mistakes managers make in managing mentally ill employees What do you do when an employee talks of suicide How to handle an employee who comes back  more...

Document Retention and Destruction You should attend this webinar 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  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...

Preventing Harassment in the Workplace by TrainHR ...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 it should be communicated,  more...

Auditing and Administrating Human Resources Policies and Practices by TrainHR This webinar will concentrate on making sure you have current human resources policies that are in compliance with applicable laws and convey the desired practices in your organization. Policy should be reviewed and updated periodically and through this webinar you can review your current policies, clarify policies for easier administration, and perhaps add new policies others to address new  more...

Effective Employee Performance Documentation Elements and Techniques by TrainHR ...entation. Employees are more productive when they know what is expected of them. Employee discipline is easier when documents are in order, and high standards are met when directions are clear. Learn simple, stress-free methods for collecting the right information, keeping the right records, and tracking performance outcomes. Good documentation has many advantages including eliminating  more...

How to Conduct an Offensive Behavior Investigation by TrainHR This program will help you understand how to conduct discrimination and harassment investigations. Learn how to avoid the legal pitfalls of conducting discrimination investigations. Learn how flawed investigations can cause nightmares for employers. Understand when you need to call in a professional to conduct your investigation. Receive updates on the most recent cases on these issues and  more...

Emotional Intelligence What it is and Why it Should Matter to You by TrainHR The most important "e-term" you may learn in 2011 is emotional intelligence. Experts say it can make or break careers and elevate executive leadership to higher levels of success, so what are the best moves and worst emotional pitfalls you can make? Learn from executive coach and nationally acclaimed author Arnold Sanow what it is and why it matters to the success of executives and the companies  more...

Master Production Record Requirements - Webinar By GlobalCompliancePanel This program will address the 21CFR and Eudralex Volume 4 requirements and interpretation, as well as FDA Guidance regarding the creation, review and approval, and control of Master Production Records. The material will enable attendees to establish a consistent approach to the design of MPR, including cover page content, instructions, processing requirements and limits, and signature  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...

Understanding and Implementing USP 1058 Analytical Instrument Qualification - Webinar By GlobalCompliancePanel Analytical instruments should be qualified to demonstrate suitability for the intended use. Despite the fact that instrument qualification is nothing new and companies spend a lot of time, it is a frequently cited deviation in FDA inspectional observations and warning letters. Companies are unsure on what exactly to qualify or re-qualify, test and document. The main reason is that unlike for  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...

What to Expect and How to Prepare for FDA Inspections - GlobalCompliancePanel As recent headlines demonstrate, non-compliance with US Food & Drug Administration US FDA laws and regulations could cost your firm millions. In addition to significant revenue losses, violative US FDA inspections may also lead to injunctions, consent decrees, warning letters, FDA 483 's Notice of Inspectional Observations, product non-approvals, import detentions, recalls, criminal  more...

HIPAA Enforcement and Compliance Audits What the auditors want and how to be ready before they call - Webinar By GlobalComplianc ...ect 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 audits will be presented. The session will also cover how to know if you may become the subject of an audit or enforcement action, and what you can do to  more...

Good Documentation Practices for Laboratory Operations - Webinar By GlobalCompliancePanel ...cal laboratory. Why Should You Attend: Discover what the FDA and EU regulations say about documentation Learn what your signature and/ or initials mean on a document See how to handle and manage data entry and errors Review "Do's" and "Don'ts" of documentation practices Discuss rounding and limit expression determinations Recognize how to sign, date and label  more...

HIPAA Security Policies and Procedures Making them useful and relevant as well as compliant - Webinar By GlobalCompliancePanel ...y policies and procedures needed for compliance. Learn what it 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  more...

Information Security and Payment Card Rules Protecting Patient Payment Data and Complying with PCI - Webinar By GlobalCompliance ...what the PCI DSS requires for protection and how the PCI DSS relates to the HIPAA Security Rule - there are substantial similarities, and being prepared for one helps you prepare for the other, as well as for other requirements, such as breach notification. We will discuss how the regulations and standards work and their legal basis, as well as provide up-to-date information on any expected  more...

Information Security Risk Analysis Meeting HIPAA Requirements and the Meaningful Use Objective - Webinar By GlobalCompliancePane ... relevant 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  more...

The GCPICH Obligations of Sponsors Monitors and Investigators - barriers and solution - Webinar By GlobalCompliancePanel ...t program is to assess the benefit / risk ratio. Learn what the risk information is that must be collected, documented and reported accurately. Learn also how the International Conference on Harmonization (ICH) has been the most outspoken as to what GCP is including a formal listing of the "Principles of GCP" and a definition that is clear. Covered also will be what the practices are that  more...

Pharmaceutical and Medical Device Validation Guidances - Similarities and Differences - Webinar By GlobalCompliancePanel ..." in FDA regulated industries for many years. Do you know what process validation is and how you would explain it to an "alien" from another industry? Now, this is not to mean that other industries do not practice process validation because they do. It is that in the manufacture of medical products, so much is at stake for the professional and their patient. It is imperative that medical  more...

Auditing an Active Pharmaceutical Ingredient API Contract Manufacturing Organization CMO - Webinar By GlobalCompliancePanel ... all influence how an API process should operate. Knowing what the FDA expects and how these regulators apply API GMP is important to API purchasers and drug product firms. Reducing risk and protecting the quality of a Drug Product (DP) is critical to the DP firm's success. The webinar will focus on the Q7 and FDA GMP requirements, what are the key contractual requirements and what should be  more...

Designing a CAPA System that Meets and Exceeds Regulatory Requirements - Webinar By GlobalCompliancePanel ...ty Engineers who design and manage the Quality system. What you will learn: * The CAPA definition * the CAPA LIFE cycle * Tools for each CAPA cycle * CAPA requirements * Tools for Preventive Action * Common FDA CAPA findings and how to avoid them Areas Covered In the Session: * Off-label statute * Label claims * Allowable reprints *  more...

21 CFR Part 11 How to Successfully Prepare for and Host an FDA Inspection - Webinar By GlobalCompliancePanel Overview: 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. Why Should You Attend: More and more organizations are striving to "go green" and develop "sustainable" organization's strategies, which almost always includes using  more...

Key Factors to Write an Effective Standard Operating Procedure SOP and Work Instructions WIs - Webinar By GlobalCompliancePanel ...ceutical, Biotech, and Medical device organizations as to what a Standard operating procedure is, and what a Work Instruction is. Areas Covered In the Session: * How to write a work instruction * How to write a standard operating procedure * Properties of an effective work instruction * Properties of an effective Standard operating procedure * The differences  more...

Design History File DHF Device Master Record DMR Device History Record DHR and Technical File TF - Regulatory Documents Explaine ...ry Record (DHR), and the Technical File (TF). Do you know what information should reside in a DHF, a DMR and a DHR? This Webinar will define, explain and clarify the different records. Are you maintaining adequate DHF, DMR, DHR, and TF records? Do you know what data and information need to reside and where does it reside? Are your records easily accessible? Are you confused by these terms?  more...

Conducting Successful Product Complaint Investigations - Webinar By GlobalCompliancePanel ...o a conclusion regarding whether the complaint was valid, what the root cause of the complaint was, and what action is necessary to prevent further occurrences. Complaints cannot be ignored. They are an excellent indicator of problems with the use, design, and/ or manufacture of a product. A single complaint that is thoroughly investigated may lead a company to take remedial or corrective  more...

How to successfully create a Device History Record and keep FDA happy in the process - Webinar By GlobalCompliancePanel ... production records regulations; with an emphasis on just what is it that FDA is looking for. Emphasis will be placed on the Quality System Inspection Technique (QSIT) which FDA uses as an inspection tool. Learning Objectives: * Learn what FDA expects and will request from you during your DHR review. * How QSIT inspections related to record keeping is performed by FDA. * How  more...

Data Security Analysis for Healthcare Providers - Webinar By GlobalCompliancePanel ...iolations. Why should you attend: Attendees will learn what 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  more...

Webinar on Cloud Computing SaaS - Webinar By GlobalCompliancePanel ...SaaS CRM system will be utilized as an example to discuss what drives SaaS system compliance and how requirements can be limited to Customer specific configurations. The scope of the validation effort will be explained and the elements of the Validation effort will be outlined. Change Management will also be discussed, with regards to how Vendor changes and customer configurations affect the  more...

Understanding Attribute Acceptance Sampling including Z14 and c0 Plans -- Webinar By GlobalCompliancePanel ...nd Bernoulli trials o The binomial formula and what it means o The cumulative binomial * Sampling plans o The AQL concept o The ideal OC curve o The practical OC curve o Reading risk off the OC curve o Special points on the practical OC curve + The AQL point + The IQL point  more...

Requirements of the Master Production Record - Webinar By GlobalCompliancePanel ... a note on Device Master Record.) In addition to learning what is meant by "list of components", the session will cover attachments and documentation expectations. Finally, the webinar will review the process and requirements for issuance and handling of Batch Production Records (BPR), and clearly describe the difference between the master and the batch production record. Why should you  more...

FDA Clinical Trial Auditing and the due diligence Companies should conduct as part of their monitoring program - Webinar By GCP ...or regulatory inspections. It will be important to see what the FDA regulations and the ICH GCP recommendations are in this regard. The key is that the PI and all clinical staff know and follow the research plan (Protocol) exactly as it is written. To do this is ethical research. To not follow the protocol and document study conduct carelessly is folly. Why should you attend: All CRO's,  more...

Gowning Systems Used in Cleanrooms Controlled Environments - Webinar By GlobalCompliancePanel ...nment. Areas Covered in the Session: * Identify what garment systems are available. * Identify and discuss good and bad cleanroom gowning. * Identify gowning techniques and sequence. * Discuss what role each garment part plays in contamination control and human safety. * Explore expectations of cleanroom garment suppliers. * Discuss cleanroom gowning tests and  more...

Facilities Cleaning in Cleanrooms and Controlled Environments - Webinar By GlobalCompliancePanel ...Covered in the Session: * Learn about cleaning and what it accomplishes in the cleanroom. * Identify cleaning agents, tools, and equipment. * Discuss cleaning personnel training and qualification. * Identify the methods of cleanroom cleaning. * Identify and discuss extent and frequency of cleanroom cleaning. Who Will Benefit: * Q auditors and personnel  more...

Calibration and Qualification in Analytical Laboratories - Webinar By GlobalCompliancePanel ...observations and warning letters. Companies are unsure on what exactly to qualify test and document. For easy implementation, attendees will receive: * 4 SOPs o User Requirement Specifications (URS) for analytical equipment o Change control for analytical equipment o Qualification of equipment o Allocating Analytical Instruments to USP  more...

The Use and Mis-use of FMEA in Medical Device Risk Management - Webinar By GlobalCompliancePanel ...e FMEA process. Areas Covered in the Session: * What is an FMEA o What are the components of an FMEA? * How should I use FMEA in performing risk management? * What are the problems with FMEA in risk management? * How is an FMEA conducted o What and who are needed o Identifying significant risks o Development of mitigating  more...

Good Documentation Practices for GMP Operations - Webinar By GlobalCompliancePanel ...bjectives of this presentation include: * Discover what the regulations say about documentation practices * Learn what your signature and/ or initials mean on a document * See how to correct errors and omissions in data entry * Learn "Do's" and "Don'ts" of documentation practices * Learn how to attach raw data to records * Review rounding and limit expression  more...

The Pharmaceutical Quality System - Webinar By GlobalCompliancePanel ...uality System. Most people are still trying to figure out what a Pharmaceutical Quality System is. Many of the components of a Pharmaceutical Quality System are in place in most companies. The various FDA and ICH guidance documents provide significant clues as to what should be in a Pharmaceutical Quality System. Regulatory guidance's, as well as contemporary quality standards, reference  more...

Controlled Substances and the Hospital Pharmacy - Webinar By GlobalCompliancePanel ...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 Control: This section will familiarize you with the authority given to DEA Diversion Group when enforcing the laws and  more...

HIPAA Business Associates How the regulations have changed and what you need to do for compliance now - Webinar By GCPanel ...ow 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 get their contractors established as their  more...

HIPAA Breach Notification What to do to prevent breaches and what to do when they happen to you - Webinar By GCPanel ...d 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 to decide if you need to notify. We'll also cover how the harm standard may be changed when final regulations are  more...

Bringing Compliance To Design Control For Older Products - Webinar By GlobalCompliancePanel ...nt regulatory requirements. As an attendee you will learn what the FDAs expectations for your released products are. You will also learn about the paper trail you are required to maintain to show compliance. Compliance regulations are released by regulatory bodies throughout the product's life cycle. It is a requirement for the manufacturer of devices to ensure that the released product is  more...

Overall Residual Risk Evaluation - Webinar By GlobalCompliancePanel Overview: This presentation discusses practical methods of performing Overall Residual Risk Evaluation and methods for documenting the results of the evaluation activity. Overall Residual Risk Evaluation requires a cross-functional team to perform the evaluation, which will be an important part of this presentation. Why you should attend: One of the most important Risk Management activities is  more...

Excel Spreadsheets Step-By-Step Instructions for Compliance - Webinar By GlobalCompliancePanel ... and validate a GxP compliant spreadsheet application. What makes this session unique is the combination of step-by-step instructions and the hands on workings of each participant. Bring your laptop and use Excel for your own needs. This session will make you a better Excel user, saving you time and costs. Areas Covered in the Session: * Develop spreadsheet applications that are  more...

The Investigation System Discovery Planning Root Cause Analysis CAPA - Webinar By GlobalCompliancePanel ...clarification on the steps of an effective investigation, what documentation is required along the way, and how to establish a comprehensive and compliant investigation system. Why should you attend: Inadequate failure investigations continue to be a major GMP deficiency cited during routine and "for-cause" inspections conducted by the FDA. While the FDA recognizes that failures are a part  more...

Recruiting is Critical to Your Success What is the Secret - Webinar By GlobalCompliancePanel ...information useful for CRO's, the sponsors must also know what is needed so they can chose the right CRO or research site to conduct their studies. Areas Covered in the Session: * How to set up and track your recruiting of subjects * The challenges of successful recruiting * The importance of your recruiting staff in the overall success of the unit or site * How to  more...

Process Validation for Medical Devices - Webinar By GlobalCompliancePanel ... effectiveness. Areas Covered In the Seminar: * What is Validation? * When should it be used? * How does it differ from verification? * Validation vs. Verification: Which One? * Protocol preparation * Different types of validation * IQ, OQ, and PQ Who will benefit: This webinar is targeted toward professionals involved in meeting FDA's Quality System  more...

How to use QSIT to Your Advantage - Webinar By GlobalCompliancePanel ...ality system. Why you should attend: If you don't know what the FDA inspector is going to look at when (s)he performs his/ her audit, how can you really know what to prepare for? Even a thorough internal audit may not focus on the areas that the FDA inspector will. The most effective way to increase the likelihood of your internal audits identifying issues that the inspector will see is to  more...

Purchasing and Supplier Controls in the Medical Device Industry - Webinar By GlobalCompliancePanel ...eptable systems in place to assure component quality. But what about supplier quality? Your company must have a procedure in place that describes the methods you use to evaluate potential suppliers, and set forth requirements that your suppliers must meet to be considered "approved." You must also have a system in place to routinely assess your suppliers, and set forth the applicable criteria  more...

Preparing for Pre-approval Inspections - Webinar By GlobalCompliancePanel Overview: This interactive webinar begins with an overview of the FDA Inspection process. Preparation for the inspection in the months before, the immediate weeks before and on the day of the inspection will be discussed. The Inspection process will be reviewed followed by a detailed look at common focus area areas of Inspectors. Procedures to be followed after the inspection such as  more...

Medical Device Recalls How to Manage Them and Recent Trends - Webinar By GlobalCompliancePanel ... * Create and use a recall operational procedure and what should it contain * Understand what are effectiveness checks * What happens in a medical device recall and your responsibility * Learn why a recall is either a correction or a removal depending on where the action takes place * Understand what is required for the recall strategy as expected by FDA * Medical  more...

XML Training ... XML Gain by learning XML 2. INTRODUCTION TO XML What is XML Sample XML The W3C XML & HTML Advantage of XML Where is XML used? Show the Demo from Google/ Amazon Webservices 3. USING XML IN APPLICATIONS Separates Data Simplifies Data Sharing Simplifies Data Transport Simplifies Platform Changes Makes Your Data More Available Used to Create New Internet  more...

Project Management for Clinical Trials - Webinar By GlobalCompliancePanel ...c data capture. Areas Covered in the Session: * What is a Project and why is it important for running clinical trials? o Defining the key characteristics of project management and the importance to clinical trials o Using an project management process for improving the success of your own clinical trials * Setting clear objectives and defining the scope of  more...

Meet FDA Expectations for a Tougher Supplier Audit Program - Webinar By GlobalCompliancePanel ...ppliers; Supplier requirements by "classification" * What's behind the COA? The COC? * The FDA's increasing emphasis on the site audit * Types of remote audits * Maintaining the relationship Who Will Benefit: * Senior management in Drugs, Devices, Biologics, Dietary Supplements * QA * RA * R&D * Engineering * Production * Operations  more...

Change Control -- Your Companys GMP Weak Point - Webinar By GlobalCompliancePanel ...Areas Covered in the Session: * Change Control a what it is; what it is not * Areas impacted by Change Control * Regulatory / FDA 483 a Hot Buttonsa * Design Control * Document Control * Identifying changes * Preventing negative changes * Maintain a 'state of control' * Business needs and obtaining 'buy-in' Who Will Benefit: * Senior  more...

Tougher US FDA cGMP Compliance Audits - When Youre Not Ready - Webinar by GlobalCompliancePanel ...dustries indicate a public's growing dissatisfaction with what they view as a lack of oversight of business by regulatory agencies, including the FDA. "Business as usual" is unacceptable. Recently several once 'model' companies have received multi-million dollar fines, with one facing criminal charges. Don't let you or your company be caught of guard by these major shifts in emphasis. Modify  more...

Information Security - Overview Information security means protecting information and information systems/ assets from unauthorized access, use, disclosure, disruption, modification or destruction. Every individual who deals with information should have a better understanding on how to safeguard his/ her personal or company's data. This session will assist partcipants to 1. Understand WHAT, HOW & WHY of information  more...

Excel Spreadsheets and FDA Device Regulations - Webinar by GlobalCompliancePanel ...plain where FDA will exercise "regulatory discretion" and what that means. We discuss the following issues: * The pitfalls of using Excel without a good regulatory plan * How to recognize when you are using software in production or the quality system * The use of Excel tools to help ensure spreadsheets are built correctly * The FDAa ™s requirements and expectation  more...

Introduction to Contamination Control Master Plans - Webinar by GlobalCompliancePanel ... your products. Areas Covered In the Seminar: * What is a CCMP and how is it valuable to my company? * What topics are covered in the CCMP and to what extent? * How is the CCMP controlled and updated? * How is the CCMP implemented? * Who contributes to the CCMP? Who will benefit: * QA personnel * Regulatory personnel * Operations managers *  more...

Process Validation current industry practices and FDA Guidance Document Review - Webinar by GlobalCompliancePanel ...pful in writing process validation protocols and deciding what can be, or should be, varied in the process. The notions of critical process control parameters and control limits are introduced and explored as tools for performing process validation. Why should you attend: Process validation is an important subject for the pharmaceutical quality or regulatory professional. Process validation  more...

International Financial Reporting Standards The Basics - Webinar by GlobalCompliancePanel ...ing 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 * Who needs to comply * The four key principles of IFRS * How disclosure requirements will change  more...

21 CFR Part 11 Complete Manual For Compliance Success - GlobalCompliancePanel Virtual Seminar - Webinar By GlobalCompliancePanel ...troduction and development of the regulation o What to expect in the future when it comes to the regulation o Options for (non)compliance o 'What ifs' o Most impactful sections and subsections of the regulations * Module 2 - How to Prepare and Host FDA Inspections o Elements and details of preparation for the inspection o  more...

Utilizing Good Requirements as a Foundation for the Effective Validation of PDMA-related Computerized Systems - Webinar By Globa ...violated PDMA requirements, it is important to understand what the requirements are and how to ensure compliance with them. Noncompliance can cost companies millions in fines. * Understanding the purpose of validation * Defining Good Requirements * Prioritizing Records * Applying the Regulatory Requirements of PDMA and Part 11 * Performing Risk Assessments *  more...

Medical Device Changes and The 510k - Webinar By GlobalCompliancePanel ...he board in its expectations for the medical industry and what it (the FDA and industry) need to do to "toughen" the 510(k) process. A review of recent information from the Agency, including last summer's Working Group findings on the 510(k), Vol. I, as well as other goals of the Agency that have already been translated into action in the past year will provide direction in areas of concern and  more...

Validating Excel and Word Applications Documents - Webinar By GlobalCompliancePanel ...dated? Company quality data must be more "science based". What V&V (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  more...

Effective Training Practices for FDA Compliance - Webinar By GlobalCompliancePanel ...ations and citations), attendees will be able to envision what to include in a GMP training program. In addition, an overview of the training system, including types of training planning, will offer considerations to make GMP training more effective. Why you should attend: Regulatory agencies around the world require that training on good manufacturing practices (GMP) be conducted on a  more...

Preparing for GFSI and other Third Party Audits - Webinar By GlobalCompliancePanel ... 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 actions Who will  more...

Chemical Control for Food Manufacturers Ingredient Cleaning and Hazardous Materials - Webinar By GlobalCompliancePanel Overview: A comprehensive review of an ideal chemical control program will be presented. The guidelines presented will enable your company to implement programs that are cost effective and meet or exceed the expectations of major QSR, and GFSI audit criteria. This presentation will provide not only a provide schematic for management and control of chemicals, but an interactive and customizable  more...

Avoiding FDA 483 Observations by Identifying the Root Cause of Deviations - Webinar By GlobalCompliancePanel ...course will include a discussion of the Deviation System, what should be investigated and the level of investigation. Several tools that will lead to the identification of the root cause will be discussed. These include: process mapping, brainstorming, cause analysis, cause and effect and the 5 Whys. The investigation system will be integrated with the CAPA and Change Control Systems. Why  more...

Using Foreign Trial Data in Your NDA Approval Process - Webinar By GlobalCompliancePanel ...oreign trial data as pivotal data for NDA approval * What you can do to ensure compliance * Design considerations and requirements for foreign trials * Identify which guidances and regulations govern the FDA's acceptance of foreign trial data as pivotal data for NDA approval; * Discuss how FDA is implementing these rules and what you can do to assure compliance; and *  more...

Complying with HIPAA Security Rules Whats in the rules and how you can most easily prepare for compliance - Webinar By GlobalCom ...hts even if no one files 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  more...

Medical Device Reporting Regulations and Violations - Webinar By GlobalCompliancePanel Overview: This presentation will review the Medical Device Reporting regulations and common violations leading to Warning Letter filings by FDA. As part of the review, actual Warning Letter and FDA-483 citations of small and large medical device manufacturers will be explored for Medical Device Reporting issues. There is a great deal of concern at FDA over the quality of the information  more...

Internal Audits Maintaining your Quality Systems at the Ready - Webinar By GlobalCompliancePanel Overview: While not captured in most audit reports, one of the biggest mistakes an organization can make is to have insufficient self audits. Internal audits are a core component of the Quality Assurance and Food Safety program. Ensuring the team representatives are trained and calibrated is a critical aspect of the program. An untrained team will miss important audit items, compromising the  more...

Operational Risk Management Ensuring Safety for Food Systems - Webinar By GlobalCompliancePanel ... foods. Risk assessment involves determining where and what types of risks are involved throughout any food process, assigning quantitative values to those risks, measuring the processes based on risk factors and ranking risk areas for purposes of preventive and corrective actions. Risk management requires no more or less management skill levels than any production, quality or purchasing  more...

Designing and Implementing the Quality System for Combination Products - Webinar By GlobalCompliancePanel ...ting and managing quality systems. They look primarily at what or if systems exist. They do not always understand how the systems operate and interact to control all the inputs that results in acceptable and superior products. Agenda Module 1: The role of the quality system & and regulatory loop Module 2: Key to success is management involvement, organizing, and training of all functions.  more...

How to Prepare and Submit a Bullet Proof 510k and Latest FDA Proposed Changes to the Process - Webinar By GlobalCompliancePanel ... application to FDA * Where to submit the 510(k) and what to expect with the review and approval process * When it is and is not required if you are a device company * Exemptions to the submission process and special considerations * How to locate a "predicate" device and go through the content and format of the 510(k) * Understand the De Novo process and the  more...

Design History File DHF Device Master Record DMR Device History Record DHR and Technical File TF - Regulatory Documents Explaine ...Record (DHR), and the Technical File (TF). Do you know what information should reside in a DHF, a DMR and a DHR? This Webinar will define, explain and clarify the different records. Are you maintaining adequate DHF, DMR, DHR, and TF records? Do you know what data and information need to reside and where does it reside? Are your records easily accessible? Are you confused by these terms?  more...

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

Excel Spreadsheets - Develop and Validate to Eliminate 483s - Webinar By GlobalCompliancePanel ...rails, security features, and data entry verification. What makes this session unique is the combination of step-by-step instructions and the hands on workings of each participant. Bring your laptop and use Excel for your own needs. This session will make you a better Excel user, saving you time and costs. Areas Covered in the Session: * Become compliance when using Excel  more...

Understanding and Preparing for FDAs New Part 11 Inspection Program - Webinar By GlobalCompliancePanel ... * Criteria for selection of target companies * What inspectors are looking for * How to prepare your company for the upcoming inspections * Learning from previous inspections with focus on Part 11 and computer validation: most frequently cited deviations * How to fill gaps short term * Developing a program for long term * Creating the right documentation to  more...

Medical Device Tracking Latest FDA Update and Expectations - Webinar By GlobalCompliancePanel ...and criteria * Understand the statutory criteria and what changed * FDA has issued orders to manufacturers who are required to track various implantable devices * Define the additional guidance factors to be considered when determining whether a tracking order should be issued * Understand why tracking methods are subject to FDA inspection * When does tracking end?  more...

Japan - Regulatory Filing Requirements and Compliance Processes for Life Sciences - Part I and Part II - Webinar By GlobalCompli ...responding agencies process filings and registrations and what is expected in the authorization and dossier maintenance of licensed products. The current regulatory climate will be discussed in depth and several examples will be provided to illustrate effective compliance procedures and techniques. Common issues which have caused difficulties for Life Sciences firms will also be discussed.  more...

How to Prevent or Handle Protocol Deviations and Violations to be GCP and Regulatory Compliant - Webinar By GlobalCompliancePane ...what happens, and 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  more...

Recalls Removals and Market Corrections in Compliance with FDA and ISO Requirements - Webinar By GlobalCompliancePanel ...h require recalls, removals, or market corrections * What to do during recalls, removals, and market corrections * Recordkeeping requirements for recalls, removals, and market corrections * ISO 13485-specific requirements * CMD-specific requirements (Canadian device regulations) Who Will Benefit: This webinar will provide valuable assistance to all regulated companies,  more...

FDA 483 Observations in the Laboratory What went wrong How can they be avoided - Webinar By GlobalCompliancePanel Overview: In order to proactively address areas of concern to the FDA and other regulators, All units within each pharmaceutical firm should review recent regulatory observations and proactively establish programs or systems to address the regulatory concerns. In this webinar we will focus on the laboratory and recent FDA laboratory based operations. We will review observations, identify the  more...

101 cGMP To-Do List for 2011 - Webinar By GlobalCompliancePanel ...he board in its expectations for the medical industry and what it (the FDA and industry) need to do internally. A review of recent information from the Agency, other goals of the Agency that have already been translated into action in the past year will provide direction in areas of concern and what to expect in the future. This will be performed by a review of 101 areas of required review or  more...

A Comparison of ICH Q-10 Quality System and the FDAs Quality Systems Approach QSA to the Pharmaceutical GMPs - Webinar By Global ...ce 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 documents? * What are some Pro and Cons of the product lifecycle for pharmaceuticals * Is the Quality Systems Approach really  more...

The FDAs Working Group Reports I II - New Directions - Webinar by GlobalCompliancePanel ...he 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) Task Force on the Utilization of Science in Regulatory Decision Making. Both  more...

The Advantages of Linking Management Systems - Webinar by GlobalCompliancePanel ... 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 managers can help improve results. In the long run there will be cost savings, continual improvement of processes and  more...

Introduction to Operational Risk - Webinar By GlobalCompliancePanel ...tegories, and 40 subcategories of operational risk * What to look for in taking a holistic and systematic approach to op risk * Comprehend the major qualitative and quantitative tools used in op risk * Understand how self assessments, scorecards, KRIs, and scenarios are used as qualitative tools * Grasp why both internal and external loss data is essential in using  more...

Know Your Customer - The DEA Due Diligence - Webinar By GlobalComplaincePanel This training will cover several recommendations to improve Due Diligence when distributing Schedules II through V controlled substances and regulated chemicals to your customers and what steps can be taken to prevent the illicit use or diversion of any product sold to a customer. As a firm handling these products, you will get a better understanding of what is required from a DEA registered  more...

Process Verification and Validation - by GlobalCompliancePanel This webinar will provide valuable guidance to regulated companies in development, implementation, or refinement of their manufacturing process verification and validation programs. It will evaluate validation practices that are more in agreement with ICH Q7 and Q8 than previously accepted validation methods, and will provide thought-provoking questions for FDA-regulated companies. Enhanced use  more...

Complaint Handling in Compliance with FDA and ISO Regulations - Webinar by GlobalCompliancePanel This session will include the requirements for defining, documenting, and implementing a complaint-handling system, including the requirements for complaint review, investigation, and corrective action, as well as the ISO-specific implications. This session will discuss the best way to document customer feedback, what constitutes a complaint, and what do with "non-complaint" feedback. Also  more...

21 CFR Part 11 - Compliance for Electronic Records and Signatures - Webinar by GlobalCompliancePanel This webinar details the regulation and how it applies to computerized systems. Learn exactly what is needed to be compliant for all three primary areas: SOPs for the IT infrastructure, industry standards for software product features, and the 10-step risk-based validation approach. This webinar demystifies Part 11, and get you on the right track for using electronic records and signatures to  more...

Auditing API Manufacturers and Suppliers - Webinar by GlobalCompliancePanel ...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 snapshots of what exists at the moment of the audit; however, a good audit or auditor will be able to uncover the less obvious signals and signs of concern. Learn what to include in an audit, what to examine, where  more...

21 CFR Part 11 - What you need to know to pass the new FDA audits - Webinar by GlobalCompliancePanel This webinar details the regulation and how it applies to computerized systems. Learn exactly what is needed to be compliant for all three primary areas: SOPs for the IT infrastructure, industry standards for software product features, and the 10-step risk-based validation approach. This webinar demystifies Part 11, and get you on the right track for using electronic records and signatures to  more...

FDAs Update on Medical Device Labeling Changes - Webinar by GlobalCompliancePanel ...al is present. The rule also provides clarification as to what the Agency considers to be new information to be incorporated into a label change. Specifically, new information "must reveal risks of a different type or greater severity or frequency than previously included in submissions" and includes meta-analyses, the new regulation states." FDA requires that drug, biologics, and medical  more...

ICH Q7 Guidelines and Practical Approaches to Manufacturing APIs - Webinar by GlobalCompliancePanel Active Pharmaceutical Ingredient Good Manufacturing Practices (API GMP) are established and defined by the ICH Q7 Guidance. The international supply chain associated with API manufacturing was one of the greatest drivers for the development and international adoption of these expectations by regulators world-wide. The growth in the number of FDA inspections of API producers outside of the USA  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...

Using SLAs to Facilitate Enterprise and IT Governance Risk Management and Compliance GRC - Webinar by GlobalCompliancePanel ...ria on GRC actions and a basis for ongoing improvement What You will Learn from the Webinar: * Receive a clear picture of the current view of GRC * Obtain a clear knowledge of SLA concepts and how they relate to the enterprise-wide view of Service Level management (SLM) and its associated Service Level Objectives (SLOs) * View an illustration of SLAs as applied to a facet of  more...

Defining and Managing Protocol DeviationViolationException - Webinar by GlobalCompliancePanel ...fine and manage Protocol Deviation/ Violation/ Exception. What is the approach to predict and prevent it. Proper documentation and reporting of PNF as they occur is helpful for investigators and study sponsors, as these data can be used to determine the need for amendments to the protocol and/ or the related documents. The monitoring of the frequency and nature of PNF can also be used as a  more...

Excel Spreadsheet Validation To Eliminate 483s - Webinar by GlobalCompliancePanel This interactive webinar provides explicit details and live demonstration followed by a collaborative workshop that explains how to configure and validate a GxP compliant spreadsheet application. What makes this session unique is the combination of step-by-step instructions and the hands on workings of each participant. Bring your laptop and use Excel for your own needs. This session will make  more...

How to Survive a DEA Audit or FINDFINE - Webinar by GlobalCompliancePanel ...ces and regulated chemicals. It covers all elements of what occurs during an unannounced DEA Diversion inspection and the auditing of all controlled substances and regulated chemicals. Why should you attend: When DEA Diversion personnel conducts an unannounced inspection of a pharmacy to perform an audit, they generally do not inform the DEA registrant on what steps will be taken during  more...

Learning from Recent FDA Warning Letters Related to Computer Validation and Part 11 - Prepare Yourself for the upcoming FDA Part ...ry had with Part 11 in the past. The best way to find out what the issues are is to look at recent FDA 483 form inspectional observations and warning letters related to computer system validation and Part 11 compliance. Just from 2007-2010, there have already been more than 30 such warning letters, some with disastrous consequences for inspected companies. This seminar will give an overview of  more...

Verification of Pharmacopeia Methods - Webinar by GlobalCompliancePanel Laboratories that work in a GMP environment are required to have documentation to show they are qualified to run specific, consistent and reliable analytical test methods. Method qualification of a method can be achieved in three ways: Validation, Verification (Compendial Methods) and Method Transfer (company methods). Lack of such documentation can result in warning letters from both the FDA and  more...

Effective Essential CAPA process to avoid FDA 483 - Webinar by GlobalCompliancePanel ...ction" otherwise referred to CA/ PA. We will first define what we mean by risk. We will then explore the factors associated with risk in compliance. We will also explore risk causing events and how to address them. A review of risk severity/ level will then ensue. Upon completion of risk part of the presentation we will define what a CA/ PA system would look like. Finally an overview of a CA/  more...

Important Sterilization Information for Product Developers - Webinar by GlobalCompliancePanel Product developers have the responsibility of the development of medical devices or healthcare products that will be sterilized; however they may not have an adequate understanding of the sterilization processes and its impact to the functionality of the product and its package. This presentation will provide information that can be used by R&D Engineers and Product Developers to aid them in the  more...

Best Practices in Complaint Management - Compliance Webinar by GlobalCompliancePanel Negative customer feedback about a medical device's performance or safety is a strong indicator of whether a firm's manufacturing process is in control. This feedback is therefore subject to many requirements in both the QSR and ISO 13485. Failure to follow up on complaints about medical devices is among the most frequently cited observations on FDA-483s. This session will include the requirements  more...

Defining Architecting and Managing Risk Assessments - Complinace Webinar by GlobalCompliancePanel ...gement arsenal. Unless a business knows at any given time what its exposures are, and how they are evolving, the mitigation steps to manage its risks can never be in lockstep with prevailing circumstances or conditions. Concise Risk Assessments are a vital component of any successful Risk based initiative. Intelligent enquiry is an art that is often little understood. How Risk Assessments  more...

Pharmaceutical Manufacturing Batch Record Review - Webinar by GlobalCompliancePanel The Learning Objectives of this presentation include: * Recognize regulatory (FDA/ EU) requirements for batch records and batch record review * Modeling best practices of a technical review of batch records * Discover the essentials of batch record reviewer qualifications and training * Acquire confidence in determining the final decision or recommendations. * Establish  more...

How to Survive a DEA Audit - Compliance Webinar by GlobalCompliancePanel This training entitled "How to Survive a DEA Audit" will cover all the record-keeping and security requirements that a DEA registrant must comply with when handling controlled substances and regulated chemicals. It covers all elements of what occurs during an unannounced DEA Diversion inspection and the auditing of all controlled substances and regulated chemicals. As a firm handling these  more...

Risk-Based Validation of cGMP Systems How much validation is enough? How much is too much? When should you validate what system? Risk-based validation is the new and FDA-preferred methodology, assuring that sufficient validation is done to meet regulatory and business requirements.  more...

PCI Data Breaches What happened What may have prevented it What if it happens to you ...ls 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 the biggest data breaches of recent years could have been prevented, how to reduce your risk of a breach and what to do if the unthinkable happens. Compliance  more...

FDA Inspections What to Expect and How to Prepare ...nel brings a new webinar on the topic of FDA Inspections: What to Expect and How to Prepare Webinar will be on March 3, 2010. Webinar will be presented by James Harris . Mr. Harris has over 25 years of senior level pharmaceutical industry experience. Following this and for the past 15 years, he operated a global consulting firm that provided guidance to firms in over 60 countries around the  more...

Basic Java Training - Short term ...or Core Java (Short term) - Duration 15-20 hours * What is Object Oriented Programming? * Understanding Classes and Objects * Hello World in Java * Java Fundamentals o Primitives, keywords, strings and arrays o Methods - Input, Output, method invocation and method flow o Members of a class - fields, methods and constructors o  more...

Organize Any Garage In No Time Whether you are listening to this webinar to help others organize their garage or if you are determined to "win the war on clutter" in your own garage, I am confident that you will become empowered to do so. Here are some of the topics you will learn that will enable you or your clienta ™s to use the garage for the purpose it was intended--to park cars--and still store the additional things  more...

Introduction to Professional Organizing - Webinar ...what it takes to enter and succeed in this dynamic and growing industry. Individuals, families and companies, large and small, welcome assistance from Professional Organizers and as our industry matures, the need for more of us that instinctively know how to turn chaos into control increases dramatically. This webinar has been created to answer the many questions that must run through  more...

DOWNsizing - Its not Just Stuff Its MY stuff - On-Demand Webinar As a Professional Organizer, you may be asked to assist Seniors and their families with the task of condensing a lifetime of treasures into a smaller space. Baby Boomers have started to turn 60; working with Seniors may be the direction you are considering for your business. Discover basic tips, tricks and techniques you can apply as you help Senior clients journey through the emotional process of  more...

Communication Skills in the Workplace It is well known that before you come to work, you have to leave your casual self back home. In the office, you're an employee, someone who's supposed to go about his/ her work in the most professional manner. There is a way to talk to your superiors, to your peers and your subordinates. This method of communication is known as workplace communication and is typically formal and to the point. So  more...

Creating a Career Changing Personal Marketing Plan Workshop Series A true career changing marketing plan is a document that sets out in detail exactly the marketing channels that will be attacked and marketing methods that will be used; creates each marketing piece; identifies exact past history production percentages and ratios; makes projections based on past history; identifies problem areas and sets out a detailed plan to correct them; establishes objective  more...

Records Management 3 - Retention Scheduling - On-Demand Webinar The third in the series of Records Management webinars covers retention schedules. Topics include what the schedule should include, how to gather the data, how to apply legislation and get approvals. Michael Oa ™Shea has been involved in Records and Information Management consulting for over 20 years. He is one of the most respected international experts in traditional and emerging forms  more...

Records Management 2 - Developing Classification Schemes that are Used - On-Demand Webinar ...what a classification scheme really is, what a corporate scheme should include, how to develop one to gain maximum buy-in and how to apply and maintain it to ensure continuing effectiveness. Michael Oa ™Shea has been involved in Records and Information Management consulting for over 20 years. He is one of the most respected international experts in traditional and emerging forms of  more...

Records Management 1 - Its A Lot More Than Filing - On-Demand Webinar ...gement is a critical function in all businesses no matter what size the organization is. The larger the company the more complex records management becomes. In this first webinar of the Records Management series, learn the basics about this profession. Start to understand the terminology and the key components such as classification schemes, retention schedules, and the management of email  more...