Effective Web-based Seminars

Master Communicator Webinar MASTER COMMUNICATOR | Thursday, March 22, 2012 | 1: 00 PM a 4: 00 PM CST Led by Alicia Marie We learn how to communicate because we want somethinga to be held, fed, etc. Most of us still communicate for that reason and only that reason, which leads to a control/ command style of communication. As most leaders have figured out, a telling and directinga simply doesna ™t work well.  more...

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

Call Center Workforce Management Certification - Live Online - August 1-3 2012 The BenchmarkPortal contact center Workforce Management Certification training course for workforce managers covers the entire workforce management process from the gathering of data to the production of forecasts, schedules, and budgets. We include lessons that benefit attendees from any sized organization, large and small, with real-world examples of solutions that work in practice - not just  more...

Call Center Workforce Management Certification - Live Online - April 4-6 2012 The BenchmarkPortal contact center Workforce Management Certification training course for workforce managers covers the entire workforce management process from the gathering of data to the production of forecasts, schedules, and budgets. We include lessons that benefit attendees from any sized organization, large and small, with real-world examples of solutions that work in practice - not just  more...

LABOR RELATIONS TRAINING ...the most difficult things for managers to do is to manage effectively in a represented environment. This is all the more true when your managers, who were used to managing in a non-represented environment, all of a sudden have to deal with labor relations issues for the first time. We will assist your managers in dealing effectively with the labor relations process and will provide an in-depth  more...

Employee Handbooks Dos and Donts ... 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 on avoiding liability in the future. Learning Objectives a How to protect your company from the top mistakes that employers make in drafting employee handbooks a How to prevent claims of implied  more...

Business Writing Training ...effective strategies to sharpen your writing skills by structuring your ideas logically, exercising diplomacy in letters and reports, and shaping your arguments. This business writing class also will help you identify specific presentation techniques for various business documents, including business plans, proposals, project plans, contracts, strategic plans, reports, procedures, and policies,  more...

Learning to work as a Team ...s team buiding training course teaches students how to be effective team members. Students learn how to communicate effectively, adapt to various personality styles, overcome common problems, work on aspects of verbal and nonverbal communication, create a supportive team environment, understand the source of team conflict, and employ different conflict resolution styles. Course activities also  more...

Effective Presentations Training ...Effective Presentations training course teaches students about creating effective presentations. Students learn how to determine realistic presentation objectives, analyze the audience, use supporting materials effectively, organize a presentation clearly, and successfully incorporate visual aids. Course activities also cover reducing the fear of speaking, remaining calm, appearing relaxed, and  more...

Managing Difficult People Training This Managing Difficult People training course teaches students to address difficult people according to their specific behavior. Students will have the opportunity to meet with several Marketing Department team members to address their difficult personalities, follow the guidelines for managing difficult people to decrease the department ' s turnover rate and meet the release date for a new  more...

Running Effective Meetings Training ...Effective Meetings training course teaches students about planning, participating in, and concluding successful meetings. Students learn how to establish the purpose and agenda of a meeting, facilitate participants ' progress toward the meeting goals, improve their leadership abilities, facilitate situation analysis, brainstorming, and decision making, foster creative thinking, manage conflict  more...

Comprehensive JSP Training ...and students will be well equipped to develop concise and effective JSP applications. The second module covers the JSTL, or JSP Standard Tag Library, actually a set of four custom tag libraries that establish a portable standard for common processing tasks in JSP. JSTL is a major part of the new scriptless authoring style encouraged (and enabled) by the JSP 2.0 specification. This module  more...

Java Swing Training ...of this pattern in JFC is critical to using the framework effectively. Event handling is treated, both handling AWT-style events, such as action events from button clicks, and handling events fired by the model that lies under a particular control. In the second module, more sophisticated and powerful controls are studied: the tree and table controls. Each is presented in a separate chapter,  more...

Introduction to JavaServer Pages This two-day module introduces JavaServer Pages, or JSP, which is the standard means of authoring dynamic content for Web applications under the Java Enterprise platform. The module begins with an introduction of Web applications in general, shows how Java servlets and JSPs establish a framework for writing Web applications, and then covers JSP 2.0 features in detail, from scripting elements to  more...

Grammar Skills Training Students of this Grammar Skills Training course learn how to use grammar effectively within their organizations. Students will learn to write effective sentences by identifying sentence elements, correctly using phrases and clauses, and understanding sentence classifications. The open, modular-style manual is designed for quick scanning in the classroom, and is filled with interactive exercises  more...

E-mail Etiquette Training ...quette training course teaches students how to use e-mail effectively. Students will learn how to write effective messages and e-policies, use e-mail accessories and passwords, and prevent your password from being stolen. Course activities also cover using the subject line, considering your recipient, managing e-mail volume, following netiquette guidelines, attaching files, preparing for  more...

Business Problem Solving and Strategic Decision Making ...se introduces students to the need for problem solving, ineffective responses to problems, the elements of an effective solution, and the skills needed for effective problem solving. Students will also learn how to avoid inappropriate responses to problems, identify types of problem solvers, overcome barriers to problem solving, and identify phases of the problem-solving process. The course  more...

Introduction to Microsoft T-SQL Training In this SQL Server training class, you ' ll learn how to build basic queries using Transact-SQL, the language of SQL Server. Then you ' ll learn how to build effective views, stored procedures, triggers, and user-defined functions, using Transact-SQL. You ' ll learn about the new enhancements to the Transact-SQL programming language including improved support for error handling and hierarchical  more...

Motivation Training In this motivation training course students will discuss the foundations of motivation. They will examine motivating and demotivating factors as well as negative thoughts. They will also discuss motivation theories and the benefits of motivation. Students will examine the concept of having a Positive Mental Attitude, and how they can work towards a PMA in their lives. During this course, students  more...

Measuring Performance of Your Global Procurement Organization How to Shape Behaviours in Global Purchasing You are invited to attend the Manufacturing Executive Institutea ™s November 8th, 2011 a Global Manufacturing Enterprise Seriesa FREE webinar, a Measuring Performance of Your Global Procurement Organizationa How to Shape Behaviors in Global Purchasing.a This montha ™s powerful 1-hour webinar has 2 important objectives: 1. Define the best alternatives for structuring a  more...

How to Conduct an Effective Monthly Variance Review Meeting It has been said that difference between a GOOD plant manager and a GREAT plant manager is often in how operating variances are routinely addressed and how corrective actions are routinely executed. Great plant managers always conduct a routine a Variance Review Meetinga each month, challenging their direct reports to explain all significant variances from plan. These variances are usually,  more...

JIRA Fundamentals Training Course ...ovides the ideal jumpstart for your team to use JIRA more effectively. The material covers all features of the product from an end-user's perspective, and provides a solid foundation for users with all levels of experience, since it explains the most effective ways to use JIRA and some handy tips for getting the most value out of the software. Attendees from this session will become proficient  more...

How to Achieve Maintain ERP Systems Master File Data Integrity ...on systems provide executives with the tools to make more effective and efficient decisions, there is increasing evidence that this promise has not been fully realized. The truth is, as information systems grow increasingly more sophisticated, executives are making an increasing number of bad decisions because the fundamental data that drives these systems is often incomplete, inaccurate or  more...

Auditing Computer Systems for FDA and International Compliance - Webinar By GlobalCompliancePanel This webinar will give a good understanding of FDA and international expectations for auditing computer systems and provide steps for cost-effective implementation. Tuesday, March 13, 2012 10: 00 AM PST | 01: 00 PM EST  more...

Avoiding FDA 483 Observations by Identifying the Root Cause of Deviations - Webinar GlobalCompliancePanel Participants will obtain a greater insight into effective investigations and ways to identify the root cause and prevent a similar deviation in the future. Thursday, February 2, 2012 10: 00 AM PST | 01: 00 PM EST  more...

Key Factors to Write an Effective Standard Operating Procedure SOP Work Instructions WIs - Webinar By GlobalCompliancePanel This webinar will instruct the participant on how to write, organize, and maintain SOPs and train personnel in a way that will ensure compliance in a way that is concise, reproducible and easy to follow. Tuesday, February 7, 2012 10: 00 AM PST | 01: 00 PM EST  more...

Computer System Validation Step-by-Step - Webinar GlobalCompliancePanel This webinar will give a good understanding of FDA requirements for computer system validation and provide steps for cost-effective implementation. Thursday, January 26, 2012 10: 00 AM PST | 01: 00 PM EST  more...

Verification of Compendial Methods according to the New USP Chapter 1226 - Webinar By GlobalCompliancePanel This webinar will give a good understanding of USP and FDA requirement and provide recommendations and tools for effective implementation. Thursday, January 12, 2012 10: 00 AM PST | 01: 00 PM EST  more...

Key Steps for Risk Assessment - Webinar By GlobalCompliancePanel ...effective implementation of QRM through the understanding of the ICH Q9 process and principles of QRM. By reviewing the standard terminology of risk management and laying the foundation for a more practical approach to applying the QRM principles of ICH Q9 to any biopharmaceutical manufacturing process and equipment, it enables you to speak the same "language of risk" as those of the regulators  more...

The Investigational Medicinal Product Dossier IMPD EU CTA vs FDA IND Comparing the Content and Agency Expectation - Webinar By G This 90 minute training course will provide your company the opportunity for comprehensive understanding of the IMPD (Investigational Medicinal Product Dossier) and the structure and content differences between a EU CTA Application and an FDA IND Application. Additionally, this webinar covers many related processes sponsors will need to know, as they file for, conduct and close-out effective  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...

Avoiding FDA 483 Observations by Identifying the Root Cause of Deviation - Webinar By GlobalCompliancePanel Participants will obtain a greater insight into effective investigations and ways to identify the root cause and prevent a similar deviation in the future. Thursday, December 8, 2011 10: 00 AM PST | 01: 00 PM EST  more...

Best Practices in Key Financial Metrics - Webinar By mentorhealth ... 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 performance indicators  more...

Bullet Proof 510k - Latest FDA Proposed Changes to the Process - Webinar By GlobalCompliancePanel This 3 hour Webinar is a primer and overview to the premarket notification process, i. e., a 510(k). A 510(k) is a premarket submission made to FDA to demonstrate that your device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device that is not subject to PMA. Thursday, November 17, 2011 10: 00 AM PST | 01: 00 PM EST  more...

Designing and Conducting Effective Structured Interviews - Webinar By TrainHR This webinar will cover the process of determining the right questions to predict success on the job, including questions to determine a cultural match to the organization, how to design a program with the advantages of structured interviews and elimination of the disadvantages some programs have  more...

A Practical Look at Discipline and Termination - Webinar By TrainHR ...a practical look at discipline and termination as part of effective performance management. You'll learn about different kinds of discipline policies and some of the legal implications of using discipline. You'll 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  more...

Telecommuting Effective Policies Practices and Program - Webinar By TrainHR This session will also cover how employees might approach their management with a proposal to adopt either a full telecommuting plan or hybrid and how to measure and justify positive results. This webinar will contain an overview of how to develop a policy  more...

Proper and Effective Handling of Child Support Garnishments - Webinar By TrainHR The information provided in this program will help the attendee accurately and completely process Child Support garnishment orders through the payroll department in compliance with federal and state requirements and regulations  more...

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

Risk Management during device design according to ISO14971 - Webinar By GlobalCompliancePanel Learn how to put an effective risk management plan in place and fulfill the requirements of ISO14971. Thursday, October 6, 2011 10: 00 AM PDT | 01: 00 PM EDT  more...

Hazard Analysis A practical guide - Webinar By GlobalCompliancePanel If you have participated in hazard analysis meetings, you have probably spent hours discussing whether a scenario is a hazard, or the cause of a hazard, or debating whether the probability of an unmitigated hazard is high or low, or went off on a tangent evaluating very unlikely hazard scenarios, or wrestled with group members who consider hazard analysis meetings a waste of time. Thursday,  more...

Effective Internal Auditing-Making Quality Systems More Efficient for the Medical Products Industry - Webinar By GlobalComplianc The different types of internal audits and how they are approached will be discussed. The Internal Audit Lifecycle will be followed from beginning to end. It will be shown that. Internal audits are not simple exercises to determine compliance to some regulatory standards. Instead, the focus must be on auditing the company's quality system to determine if they are meeting their objectives and are  more...

Document Approval Control and Distribution How to Meet FDA QSR and ISO 13485 Requirements in a Cost Effective Manner - Webinar B This webinar will provide valuable assistance to all regulated companies, since a CAPA program is a requirement across the Medical Device, Diagnostic, Pharmaceutical, and Biologics fields.  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...

The Drug Development Process - From RD to Commercialization - Webinar By GlobalCompliancePanel In today's fast-paced, highly regulated and risk-aversive environment, functional groups can no longer work in isolation, but must collaborate extensively to design, develop, manufacture, test, validate and commercialize new drugs. Successful commercialization depends on effective processes to bring both the drug supply manufacturing processes and controls as well as the associated data and  more...

Implementing a Quality Systems-Based Approach to GCP Compliance - Webinar By GlobalCompliancePanel Ensuring GCP quality has often been approached from the perspective of reviewing as many documents as possible, looking for errors and following up on corrections or making "notes to file." In order to design, implement, and maintain GCP compliance in an effective manner, a Quality Systems Approach should be adopted.  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...

Business Analyst Competency Development Program ...ter and grow faster. We consult with our clients to build effective organizations, innovate & grow, reduce costs, manage risk & regulation and leverage talent. Who should attend? a Entry-level IT Business Analysts a Non IT professionals aspiring to get into Business analysis/ analyst. a Self-taught IT Business Analysts wanting to fill in the gaps and put all the pieces together a  more...

A Simpler Approach to Implementing or Validating CGMPs to 21 CFR 11 Electronic Records Signatures - Webinar By GlobalComplianceP ...oftware validation can realistically only be accomplished effectively if "risk-based". How can this be accomplished in the "real world". This webinar will address software that is supporting the company's Quality System and cGMP documentation. It will assist in evaluating software vendor claims to separate compliant software from "vaporware". A manufacturer is responsible to identify  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...

Design Planning and Conducting Effective Audits - Webinars by gcp 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 also be a source of improvement.  more...

Design Planning and Conducting Effective Audits by gcp 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 also be a source of improvement.  more...

Assessing Unemployment Insurance Cost Controls by Train HR This webinar discusses the purposes and methodologies of UI audits in assessing an organization's unemployment insurance controls and the use of UI audits in reducing the organization's UI risk exposure and lowering UI tax liabilities and costs. Critical areas of UI cost management are reviewed and effective cost control strategies are identified.  more...

FDAs final Medical Device Data System Rule FDA's promulgation of Electronic Medical Records, introduction of Meaningful Use and desire to automatically acquire medical device data for inclusion in electronic records has resulted in the development of Medical Device Data Systems.  more...

Breakthrough Performance Management that is Practical Effective and User-Friendly ...the actions necessary to achieve them. Using a simple but effective protocol and checkpoints along the way, the manager is assured that the employee is progressing as planned and the employees always knows whether they are on-track to produce the right kind of results. Use performance conversations instead of the negative performance confrontations that occur at annual appraisals is a 21st  more...

Document Retention and Destruction ... they should be destroyed in order to stay in compliance. Effective Human Resource Departments should have a documented Plan to manage employee records safely and effectively. Why should you attend: In order to be in compliance with recordkeeping compliance you should review your policies and practices on record retention and destruction on a regular basis. This webinar will cover federal  more...

Preventing Harassment in the Workplace by TrainHR ...ment in the workplace. It will cover what should be in an effective Harassment policy, how it should be communicated, and who is held responsible for assuring compliance. Also included is handling complaints, documenting charges and conduct and addressing any situation that may be construed as harassment. It will also describe liability for the company and/ or its supervisors. It will discuss  more...

Effective Employee Performance Documentation Elements and Techniques by TrainHR ...d defend yourself from legal challenges by producing more effective performance documentation. 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  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...

Document Retention and Destruction by TrainHR 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...

Developing an Effective CAPA Strategy through Root Cause Analysis of Failures Deviations - Webinar By GlobalCompliancePanel Inadequate failure investigations continue to be a major GMP deficiency cited during routine and for-cause regulatory inspections. This webinar highlights FDA and EU regulations and how to successfully approach a failure investigation and engage in subsequent root cause analysis  more...

Effective Risk Based Approach to Auditing and Qualifying Suppliers and Vendors - Webinar By GlobalCompliancePanel This webinar will demonstrate how to implement an effective audit program. Regulatory agencies hold firms responsible for delivering high quality products that meet all established requirements and specifications. Suppliers and vendors play a key role in accomplishing these mandates and it is the firm's responsibility to make sure vendors/ suppliers are meeting specifications for the supplied  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...

Information Security and Payment Card Rules Protecting Patient Payment Data and Complying with PCI - Webinar By GlobalCompliance ... they impact you * Find out how to create useful and effective security policies and how to document compliance with them. * Learn what are the first steps to take in attaining compliance with these increasingly important requirements. Who Will Benefit: * Compliance director * CEO * CFO * Privacy Officer * Security Officer * Information Systems  more...

Develop and Execute the Company Software VV Program - Webinar By GlobalCompliancePanel ...oftware validation can realistically only be accomplished effectively if "risk-based". How can this be accomplished in the "real world". This webinar will address software that is: * As-Product * In-Product * In Production and Test Equipment and * The Quality System A manufacturer is responsible to identify these requirements and implement them into an effective  more...

Root Cause Analysis - The Heart of a Successful CAPA Program - Webinar By GlobalCompliancePanel ...lution. Growing high-profile field problems indicate that effective root cause analysis is still not the industry norm. The billions of dollars spent by industry annually on quality / GMP are not providing the product safety or efficacy seemingly promised. And for most companies, the fixes are not rocket-science, but proper up-front risk-based, closed-loop RCA as an integral part of CAPA,  more...

Key Factors to Write an Effective Standard Operating Procedure SOP and Work Instructions WIs - Webinar By GlobalCompliancePanel ...s webinar is designed to outline the characteristic of an effective work instruction, and Standard operating procedure. The webinar is also designed to help differentiate Work Instructions from Standard operating procedures. Attendees will learn the steps used to write effective work instructions and Standard operating procedures. Why Should You Attend: The current shift in FDA thinking  more...

Conducting Successful Product Complaint Investigations - Webinar By GlobalCompliancePanel ...arious aspects of product complaint investigations. An effective complaint handling system is an extremely important part of any quality system. Manufacturers should understand that any complaint received on a product shall be evaluated and, if necessary, thoroughly investigated and analyzed, and corrective action shall be taken. The results of this evaluation should lead to a conclusion  more...

Understanding Attribute Acceptance Sampling including Z14 and c0 Plans -- Webinar By GlobalCompliancePanel ...ng process and your manager asked to make sure it is cost effective. She also knows there is some risk associated with sampling, but she admits she doesna ™t completely understand it. You now have a new assignment; assure your manager that you have good balance between risk and cost. The person who set up the system retired a few years ago and isna ™t available to help. You have also  more...

Calibration and Qualification in Analytical Laboratories - Webinar By GlobalCompliancePanel ...lytical Instrument Qualification * Development of an effective equipment qualification master plan * Calibration/ qualification phases: design qualification, installation qualification, operational qualification, performance qualification * Allocating equipment to qualification categories A, B and C * Qualification and documentation requirements for each category *  more...

Validation of ExistingLegacy Computer Systems for FDAEU Compliance - Webinar By GlobalCompliancePanel ...s, and it will have recommendations and provide tools for effective implementation. Reference material for easy implementation: * SOP: Retrospective Validation of Computerized Systems * Checklist: Retrospective Validation of Computer Systems Areas Covered in the Session: * Definition of legacy systems and retrospective validation * FDA requirements and inspection  more...

HIPAA Breach Notification What to do to prevent breaches and what to do when they happen to you - Webinar By GCPanel ...ch notifications with HHS. o What goes into an effective breach notification policy? o How to prevent breaches as much as reasonably possible. o What steps to take when a security incident or breach has occurred? o How to consider the risk of harm to the individual, and the risks of reporting and not reporting an incident. o How to best  more...

The Investigation System Discovery Planning Root Cause Analysis CAPA - Webinar By GlobalCompliancePanel ...guidance, and to the essential skills necessary to ensure effective and efficient investigations. Topics will examine each step of the investigation process from failure identification and notification through documentation. Participants will review root cause analysis techniques and observe how to identify corrective and/ or preventive actions towards successful remediation and closeout. This  more...

Process Validation for Medical Devices - Webinar By GlobalCompliancePanel ... N99-10 while offering information on how to implement an effective validation program. The purpose of this course is to provide an introduction to the fundamentals of process validation, explaining how, when, where and why one should validate. Participants will learn how to comply with FDA and international regulations for validation protocols. Attendees will also learn how to maintain  more...

How to use QSIT to Your Advantage - Webinar By GlobalCompliancePanel ... 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 arrange your internal audit scheme to mimic the process the FDA inspector will use. If you perform your internal audits this way, you'll be well prepared for the FDA. Areas Covered In the Seminar: * History of  more...

Does your Equipment Program meet current regulatory expectations - Webinar By GlobalCompliancePanel ...which is required for critical for go-no-go decisions. An effective Equipment Program is also an expectation in GLP and GMP laboratories. Areas Covered In the Seminar: * FDA requirement for Equipment systems * Overview of GMP/ GLP requirements for equipment * IIQ/ OQ/ PQ of Equipment * Equipment database * Equipment SOPs * Equipment Calibration and maintenance  more...

Medical Device Recalls How to Manage Them and Recent Trends - Webinar By GlobalCompliancePanel ...n the level of control necessary to assure the safety and effectiveness of the device. Recalls of Class II devices represent 61% of all device recalls over a review period, followed by Class III devices at 28%. This Webinar will provide a recent update on the latest trends and causes for device recalls and emerging trends. Recall means the correction or removal of a device for human use  more...

Project Management for Clinical Trials - Webinar By GlobalCompliancePanel ... Identifying the possible causes of problems o Effective communication and how to manage stakeholders o Implementing project control and reporting systems * Project Review and Learning for clinical trials Who Will Benefit: * Clinical Project Managers * Clinical Research Leaders * Project managers * Study managers * Clinical research  more...

Developing and Using the Product Risk Management FileReport - Webinar By GlobalCompliancePanel ...f design activities to support the production of safe and effective product. Product risk management is a required tool to drive and direct resource constrained product design, manufacture and validation activities in the company. High-profile field problems indicate that such activities are not yet adequately planned executed, and visibility maintained. There is a failure to fully utilize the  more...

Effective Corrective and Preventive Actions CAPA 10 Steps to Success - GlobalCompliancePanel Virtual Seminar - Webinar By Global ...CAPA process. It includes elements of Quality Tools, Team Effectiveness, Awards & Recognitions, and Verification & Validation of actions taken. Attend this webinar to grasp the A to Z of CAPA and learn how to implement & manage it for success. Why Should You Attend: We have found out, through auditing many organizations world-wide that the organizations are pretty good when it comes to  more...

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

Hazard Analysis vs FMECA Differences and Commonalities - Webinar By GlobalCompliancePanel Overview: The terms "Hazard and Risk Analysis" and "Failure Mode, Effects and Criticality Analysis (FMECA)" are often used synonymously. However, there are significant differences in both methodologies and their strengths can be combined to ensure a safe and efficacious system design. The presentation will explain both methodologies and will show ways how these tools can be used to complement  more...

Effective Training Practices for FDA Compliance - Webinar By GlobalCompliancePanel ...requirements, the frequency of training, how do design an effective training program, who is responsible for training, training effectives and training documentation. By examining the GMP expectations on training from different regulatory bodies (from the regulations and citations), attendees will be able to envision what to include in a GMP training program. In addition, an overview of the  more...

Chemical Control for Food Manufacturers Ingredient Cleaning and Hazardous Materials - Webinar By GlobalCompliancePanel ...l 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 course for personnel to meet program training requirements. Why you should attend: Recalls for chemical  more...

Avoiding FDA 483 Observations by Identifying the Root Cause of Deviations - Webinar By GlobalCompliancePanel ...viations. Participants will obtain a greater insight into effective investigations and ways to identify the root cause and prevent a similar deviation in the future. The investigation of deviations is clearly a US FDA expectation. The international regulatory expectation for a structured approach to investigations that lead to corrective actions and preventive actions is clearly stated in  more...

Analytical Instrument and Equipment Qualification in Quality Laboratories - Webinar By GlobalCompliancePanel ...ations that cover each environment and present simple and effective strategies for satisfying the requirements. The impact of USP on analytical instrument qualification will be reviewed and the newest regulation will be presented in a simple and understandable way. The interaction of calibration, qualification, method validation and equipment maintenance on laboratory compliance and data  more...

How to Prepare and Submit a Bullet Proof 510k and Latest FDA Proposed Changes to the Process - Webinar By GlobalCompliancePanel ...e that your device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device that is not subject to PMA. There are three types of Premarket Notification 510(k)s that may be submitted to FDA: Traditional, Special, and Abbreviated. The Special and Abbreviated 510(k) methods were developed under the "New 510(k) Paradigm" to help streamline  more...

Key Concepts in Successful Water System Sanitization - Webinar By GlobalCompliancePanel ...tization concepts * Use this understanding to design effective microbial control measures for your water systems * Use this understanding to solve microbial problems originating from poor sanitization practices * Debunk a few water system myths related to sanitization Who Will Benefit: This webinar will be valuable for all companies that operate WFI or Purified Water systems,  more...

Japan - Regulatory Filing Requirements and Compliance Processes for Life Sciences - Part I and Part II - Webinar By GlobalCompli ...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. Course content will also explain how Japan interacts with and utilizes ICH standards and how they relate with other national regulatory agencies. The course will also discuss how personnel can best  more...

The Drug Development Path - From RD to Commercialization - Webinar By GlobalCompliancePanel An overview of the drug development process, reviewing key deliverables for each stage of the development path with a special focus on managing the development process when using external resources such as Contract Manufactures, Contract Testing Labs and Contract Research Organizations. In today's fast-paced, highly regulated and risk-aversive environment, functional groups can no longer work  more...

Training Requirements and Practices to Assure QSR and ISO Compliance - Webinar by GlobalCompliancePanel ...iar with requirements that impact them. A complete and effective employee training program must be in place to assure this. This session will instruct attendees on the regulatory requirements of personnel training, and establishment of a training program, including new employee training, methods of training, how to document training so that it is readily available for review (by managers,  more...

Crisis Management and Risk Communication - Webinar by GlobalCompliancePanel ...most impossible to prevent at all time. However having an effective crisis management program, at least your team can manage the crisis situation appropriately with necessary response actions, protect the health and safety of your customers, comply with regulatory requirements/ laws and protect the image and reputation of the company and its products. This presentation will help you to have a  more...

How to Write Standard Operating Procedures SOPs and Work Instructions WIs - Webinar by GlobalCompliancePanel This webinar is designed to outline the characteristic of an effective work instruction, and Standard operating procedure. The webinar is also designed to help differentiate Work Instructions from Standard operating procedures. Attendees will learn the steps used to write effective work instructions and Standard operating procedures.  more...

FDAs Update on Medical Device Labeling Changes - Webinar by GlobalCompliancePanel ...scovered risks. The labeling regulations, which became effective in late September 2008, clarify that a manufacturer can make unilateral pre-FDA approved labeling changes "only to reflect newly acquired information" when there is "reasonable evidence of a causal association" between the drug or device and the risk. The final rule defines "newly acquired information" as "information not  more...

Supplier Evaluation and Assessment How to Meet FDA QSR and ISO 13485 Requirements in a Cost-Effective Manner - Webinar by Global Supplier qualification and assessment is required in both the QSR regulations and ISO standards. Many companies spend a great deal of time and money in pursuit of compliance with this. Many companies can spend MUCH LESS time and money, and still be in control of their suppliers and in compliance with the regulations. This presentation will review the QSR and ISO requirements for supplier  more...

Value-Adding Internal Auditing Learn how to get your Internal Audit System to promote improvements and add real value to your or ...ompany. It provides management with information about how effectively a company controls the quality of their processes and products. Auditors must perform their jobs competently to ensure their company's compliance with pharmaceutical GMP regulations and other quality standards. This course provides information to increase an auditor's ability to audit in a professional and knowledgeable  more...

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

Food Traceability Program and Efficacy Verification - Webinar by GlobalCompliancePanel ...d will be explored. The resources necessary to achieve an effective result will be presented. A customer perspective on the importance of product traceability from a customer perspective will be shared with the attendees to bring justification for team support of these time consuming exercises. Specific examples of the costs of an expanded vs a targeted recovery. Daily process documentation is  more...

Secrets of an Effective CMC Regulatory Strategy for Biopharmaceuticals Part 1 - Cell Banking - Webinar by GlobalCompliancePanel Cell banking assures that an adequate supply of equivalent well-characterized cells exist for production over the expected lifetime of the biopharmaceutical. Cell line development followed by preparation of the master/ working cell banks is an expensive process and needs to be done right the first time. Cell banks acceptable for early clinical trial material production have been found not to  more...

Signal Detection and Case Processing Business Process Optimization in Pharmacovigilance - Webinar by GlobalCompliancePanel ...ssess and optimize pharmacovigilance operations from cost effective, compliance, and safety perspectives. A structured methodology for assessing drug safety operations will be presented. This will include recognizing the need to conduct process analysis, developing and prioritizing project portfolio, performing the analysis, and finally implementing the findings. The methodology has  more...

Developing an Effective Supplier and Internal Auditing System - Webinar by GlobalCompliancePanel The FDA regulations contain a vast quantity of requirements, which govern tasks performed by your company's personnel every day. Are there going to be noncompliance? You bet. Are you going to correct these noncompliances? Only if you identify them. To ensure substantial compliance, your company needs an effective audit program for both internal and external processes. To have an effective audit  more...

Preparing for and Surviving an FDA Inspection - Webinar by GlobalCompliancePanel 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. The key to a successful audit is being able to communicate how your quality systems assure this state of control. However, the  more...

Outsourced processes and ISO 90012008 - Webinar by GlobalCompliancePanel In 2008, a new edition of ISO 9001 went into effect. The literature says the new version doesn't introduce any new requirements but only clarifications to the existing requirements. One of the clarifications involves the use of Outsourced Processes in the Quality Management System. The changes clarify the organization's responsibility for conformity to all customer, regulatory, and statutory  more...

Effective Essential CAPA process to avoid FDA 483 - Webinar by GlobalCompliancePanel ... the core principles and practices needed to implement an effective and efficient CA/ PA process. This presentation will begin by defining risk in compliance and the methods, which can be used to mitigate risk. One of the methods defined by the regulators and the industry is "Corrective Action / Preventive Action" otherwise referred to CA/ PA. We will first define what we mean by risk. We  more...

Key Modules of an Effective CAPA SOP - Webinar by GlobalCompliancePanel This webinar will examine the stated intent of the Agency to get tougher across the board in its expectations for the medical industry and its compliance to the cGMPs, especially CAPA. It will examine how these goals of the Agency have translated into action in the past half year, with trends evident in 483 observations and Warning Letters. A key to effective relations with the FDA is the emphasis  more...

Marketing on A Budget This workshop has helped and will help you, the small business owner, work from home parent and entrepreneur. When markeitng we are all looking for affordability as well as an effective way to market. This seminar willgo over the different areas of marketing, how to find the cost effective way to market based on your company goals.  more...

Regulatory Requirements for Medical Device Calibration Programs - Webinar by GlobalCompliancePanel ...al component of every Quality Management System (QMS). An effective system includes more than just management of stickers on equipment. This presentation will give you the background need to understand the requirements and effectively implement. The presentation states with the regulatory requirements in the FDAa ™s QSR, ISO 13485, and ISO 9001. After analysis of these requirements, the  more...

Failure Modes and Effects Analysis FMEA - An Effective Tool for Medical Device Risk Management - Compliance Webinar by GlobalCom The presentation will discuss the proper use of FMEA in risk management and how to recognize and avoid the traps associated with this tool in order to have a more efficient risk management process.  more...

Design Planning and conducting Effective audits ...w 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 also be a source of  more...

How to Conduct an Effective Initial Consultation - On-Demand Webinar Every successful client relationship starts with a Needs Analysis during the Initial Consultation. This Webinar gives you the core knowledge and skills to accurately assess and create relevant systems and solutions that truly enhance your clientsa ™ lives and environments and to create your customizable needs analysis forms. Certified Professional Organizer ® Debra Milne will teach you  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...

Records Management 5 - Additional RM Program Components - On-Demand Webinar ...rogram components that should be considered to develop an effective and efficient program. Topics covered include: vital records protection; choosing the right medium or mix of media for storing the records; scanning records; policies and procedures; privacy; placing records on hold for litigation; and managing offsite storage. Michael Oa ™Shea has been involved in Records and  more...

Improving Communication ... they do Recognize the types of communication that are effective and ineffective with each style Develop specific communication strategies that build a culture of alliance and collaboration You can register for this class online, within 24 hours you will receive an e-mail with a link with instructions, please follow the link and directions, when answering the questions on the  more...