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Assurance Training Seminars and Classes

From Requirements Solutions Group

How to Manage Changing Requirements

Managing requirements change has been a major challenge even for the best-run projects. Keeping track of how the changing business environment impacts ongoing projects and production applications can be a nightmare without proper tools and techniques. The concept of requirements management is not new but with an increase in the use of off-shore developers and off-the-shelf solutions, it has become more...

From The College of Call Center Excellence

Call Center Quality Assurance Certification - Live Online - September 5-7 2012

Build a Best-in-Class Customer Service Center with Quality Assurance Monitoring Training. The quality assurance workshop provides participants with an understanding of the elements that are crucial in building a well-planned program that meets the strategic needs of the organization. Those goals and/ or needs may be orientated toward Cost, Service, Sales or Marketing. more...

Call Center Quality Assurance Certification - Live Online - June 6-8 2012

Call Center Quality Assurance Certification - Live Online - March 7-9 2012

From Webucator

MOC 8824 - Sales Order Processing in Microsoft Dynamics GP 10.0 ...additional functions setting up process holds for quality assurance and linking order documents to purchase orders.A thorough understanding of these topics allows you to boost sales order processing productivity and help improve customer service by automating sales order workflow procedures. Microsoft Dynamics GP Sales Order Processing gives you precise control over the flow of sales documents more...

From Manufacturing Executive Institute

A Case for Routine Use of Statistical Process Control SPC in Manufacturing You are invited to attend the Manufacturing Executive Institutea ™s FREE February 2011 3rd Thursday - a Operations Improvement webinar, A Case for Routine Use of Statistical Process Control (SPC) in Manufacturing. Statistical Process Control is a term that describes a process for predicting failures and methodically determining the underlying cause(s) before the predicted failures can more...

From GlobalCompliancePanel

Medical Device Process Validation - Statistical Aspects - Webinar By GlobalCompliancePanel The FDA QSR requires device manufacturers to validate processes when the manufacturer cannot "fully verify the output". The manufacturer must validate these processes with a "high degree of assurance". The presentation explores the statistical underpinnings of these two phrases. To "fully verify the output" relates to the use of statistical sampling plans, while "high degree of precision" relates more...

Advanced HR Audit Techniques - Webinar By TrainHR ...ndent, objective, and systematic evaluation that provides assurance that: 1) compliance and governance requirements are being met 2) business and talent management objectives are being achieved 3) human resource management risks are fully identified, assessed, and managed; and 4) the organizationa ™s human capital adds value. Under this definition, HR audits are more than an assessment 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...

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...

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...

Statistical Concepts of Process Validation BY GCP The FDA QSR requires device manufacturers to validate processes when the manufacturer cannot "fully verify the output". The manufacturer must validate these processes with a "high degree of assurance". more...

How to Create Configure and Manage a Design Inputs - Design Outputs Traceability Matrix utilizing the principles of Lean Documen Design Inputs, Design Outputs, and Traceability matrices present a challenge to almost all industries that apply design controls. Typically, these cause the creation and maintenance of duplicate information across various documents - a major source of errors. This webinar applies the Theory of Lean Documents and the corresponding Theory of Lean Configuration to avoiding these errors, while more...

Creation and management of a Controlled Document System for a Life Sciences manufacturing plant utilizing the principles of Lean Controlled documents are one of the foundational building blocks of a Quality Management System (QMS) for regulated industries. Too often, controlled documents are cluttered, confusing, and cause many errors due to the way they are created, organized, and managed. This webinar applies the Theory of Lean Documents and the corresponding Theory of Lean Configuration to this key part of a QMS. more...

Creation and configuration of a Equipment Facilities and Preventive Maintenance System utilizing the principles of Lean Document Proper preventive maintenance and management of process equipment, and facilities is the foundation for any manufacturing process, including many processes not typically thought of as manufacturing. more...

Creation of DHFs DMRs and DHRs utilizing the principles of Lean Documents and Lean Configuration by GlobalCompliancePanel Design History Files (DHF), Device Master Records (DMR), and Device History Records (DHR) are key building blocks used in the design, development, manufacturing, and cGMP compliance for the Medical Device Industry. Too often, these are cluttered, confusing, and cause many errors due to the way they are created, organized, and managed. This webinar applies the Theory of Lean Documents and also more...

Creation of DHFs DMRs and DHRs utilizing the principles of Lean Documents and Lean Configuration - by GlobalCompliancePanel Design History Files (DHF), Device Master Records (DMR), and Device History Records (DHR) are key building blocks used in the design, development, manufacturing, and cGMP compliance for the Medical Device Industry. Too often, these are cluttered, confusing, and cause many errors due to the way they are created, organized, and managed. This webinar applies the Theory of Lean Documents and also more...

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

Introduction to Master Validation Plans - Webinar By GlobalCompliancePanel

This webinar provides an introduction to the creation, implementation, and maintenance of Validation Master Plans. Key benefits of this seminar include: Achieve satisfactory inspections more easily. Higher assurance of new medical product approvals. Minimize nonconformances. Reduce rates of batch rework and rejections. Avoid product recalls. Take a holistic more...

Requirements of the Master Production Record - Webinar By GlobalCompliancePanel Overview: 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...

Facilities Cleaning in Cleanrooms and Controlled Environments - Webinar By GlobalCompliancePanel ...hieve satisfactory inspections more easily. * Higher assurance of new medical product approvals. * Minimize nonconformances. * Reduce rates of batch rework and rejections. * Reduce cleaning-related environmental contamination issues. * Avoid product recalls. * Understand industry standards in cleanroom cleaning Why should you attend: Cleanroom cleaning processes more...

The Pharmaceutical Quality System - Webinar By GlobalCompliancePanel Overview: This webinar will discuss the evolution of the standards, describe a Pharmaceutical Quality System and discuss the transition to the Pharmaceutical Quality System. Why you should attend: The US FDA, and regulatory agencies around the world, are actively promoting the concept of a Pharmaceutical Quality System. The concept of a Quality System was imposed on the medical device industry more...

Navigating the Regulatory Environment for the Implementation of Alternative Microbiology Technologies - Webinar By GCPanel Overview: Rapid microbiological methods (RMMs) have been implemented by a number of companies around the world. In some cases, it is necessary to work with regulatory authorities in order to effectively introduce a RMM in place of an existing microbiology method. This is especially true if the existing method is incorporated in a previously approved regulatory dossier, such as a New Drug more...

Validating Rapid Microbiological Methods - Webinar By GlobalCompliancePanel Overview: Method validation is the process used to confirm that an analytical procedure employed for a specific test is reliable, reproducible and suitable for its intended purpose. All analytical methods need to be validated prior to their introduction into routine use, and this is especially true for novel technology platforms, such as rapid microbiological methods (RMMs). Because many RMM more...

Purchasing and Supplier Controls in the Medical Device Industry - Webinar By GlobalCompliancePanel ... purchasing and supplier control requirements provide the assurance that only acceptable components are used to manufacture finished devices. Most medical device manufacturers have acceptable 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 more...

Introduction to Contamination Control Master Plans - Webinar by GlobalCompliancePanel ...chieve satisfactory inspections more easily * Higher assurance of new medical product approvals * Minimize nonconformances * Reduce rates of batch rework and rejections * Avoid product recalls * Identify and control the key contamination concerns for your company * Take a holistic approach to contamination control * Achieve synergy among control programs more...

Cleanroom HEPA Filter Testing Certification An Owners Guide - Webinar by GlobalCompliancePanel ...chieve satisfactory inspections more easily * Higher assurance of new medical product approvals * Minimize nonconformances * Reduce rates of batch rework and rejections * Avoid product recalls Why you should attend: Regulatory agencies expect manufacturers to periodically demonstrate that cleanrooms and controlled environments perform according to their design 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...

Using Foreign Trial Data in Your NDA Approval Process - Webinar By GlobalCompliancePanel Overview: In this NDA Approval Process training Webinar learn the guidance and regulations governing FDAa ™s acceptance of foreign trial data and know how FDA implementing these rule along with design considerations and requirements for foreign trials. Why you should attend: While the law allows 100 percent of pivotal data to come from foreign trials, there have been very few such more...

Internal Audits Maintaining your Quality Systems at the Ready - Webinar By GlobalCompliancePanel ...s. 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 confidence in the companya ™s ability to assess and improve its own systems. Why you should attend: Maintenance is often found more...

Assessing GCP Compliance in Clinical Trial Audits- Risk management and Best practices - Webinar By GlobalCompliancepanel ...l Review Boards (IRBs). Why you should attend: Quality assurance is defined as a "systematic and independent examination of trial-related activities and documents" that allows an auditor to determine whether or not the clinical trial was conducted according to the regulations and guidance that govern clinical research. This course will provide an overview of auditing skills and techniques more...

How to Prepare and Submit a Bullet Proof 510k and Latest FDA Proposed Changes to the Process - Webinar By GlobalCompliancePanel Overview: 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. There are three types of Premarket Notification 510(k)s that may more...

Statistical Sampling Plans for Audits - Webinar By GlobalCompliancePanel Overview: The purpose of auditing is to identify failures in the system or gross negligence. The real question, "how bad does the system need to be for auditing to work?" This talk will look at statistical distribution for rare events to show that the sample size needs to larger when the systems are better. This is a paradox for most auditors who when a problem is discovered increase their more...

Recalls Removals and Market Corrections in Compliance with FDA and ISO Requirements - Webinar By GlobalCompliancePanel Overview: To satisfy QSR and ISO 13485 requirements, medical device companies must respond to field reports swiftly and compliantly. There are certain circumstances in which a report from the field requires the device manufacturer to take steps regarding product in the field. It is critical that the company take the required steps in the required timeframes. FDA and ISO requirements overlap to 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...

A Comparison of ICH Q-10 Quality System and the FDAs Quality Systems Approach QSA to the Pharmaceutical GMPs - Webinar By Global ...sented. This webinar will be very informative for Quality Assurance personnel who have the desire to move toward implementing quality concepts rather than focusing on the strict rules of compliance. This webinar will show how to strike a balance between compliance and quality. Areas Covered In the Session: * What are the objectives of ICH-Q10 and the FDA's Quality Systems Approach to more...

Statistical Concepts of Process Validation - Webinar by GlobalCompliancePanel ...urer must validate these processes with a "high degree of assurance". The presentation explores the statistical underpinnings of these two phrases. To "fully verify the output" relates to the use of statistical sampling plans, while "high degree of precision" relates to process capability. The presentation illustrates the statistical concepts. The Global Harmonization Guidance document on more...

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

Preparing for and Surviving an FDA Inspection - Webinar by GlobalCompliancePanel ...t 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 arrival of an investigator for an inspection can still be an more...

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

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

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

From International Contact Center Academy

Before You Hit Send How to Write Business-Friendly Emails That Create Emotional Connections and Leave Customers Saying WOW Every email your employees send out has your company's brand in the signature line and it puts your corporate reputation on the line. A great email can completely restore customer confidence in your brand and regain goodwill. But, at the fingertips of a disgruntled customer, your emails can be plastered all over the Internet by way of a powerful blog. In Before You Hit Send, Myra shows your more...

Contact Centre Group 2010 Webinars Lean Six Sigma Demystified Practical Easy to Implement Ideas A Handy Guide for Managers Su ... and foundational practices that comprises a good quality assurance program within contact centers. In this continuing two part webinar, attendees will learn: a Learn how proven LSS principles can be used for contact centers effectively and with little cost a Understand the central role of QA, WFM and PMS tools for agent skill development and coaching a Learn about LSS tools used more...

From iGallant Solutions

CobiT Essentials ... assist them in implementing IT Governance and support IT Assurance. Course Fee 695 $ (USD) per Participant 10% discount for 3 or more participants. 10% Early Bird discount (Should register 30 days in advance) Features: 1. Our passing rate for COBIT Essentials is more than 95%. 2. We give Unique Passing Warranty.(We will pay for your second attempt if you do not pass) 3. Group more...

From Global BioPharmaceutical Resources, Inc. (GBPR, Inc.)

How to be Compliant and competitive For healthcare companies compliance with all applicable regulations is imperative and it is usually well understood how this can be achieved. However, in a highly competitive and increasingly global marketplace, mere compliance is insufficient for success. Competitiveness must be achieved not only through cost efficient manufacture and supply, but also by achieving compliance at the right cost more...

From Business Expert Webinars

Get Your Sales Team Selling with Confidence! Remove Obstacles to Turn Problems into Profits Is your sales team delivering the results you desire? If not, there could be a reason, other than the economy, that is causing sales paralysis. While some issues may be skill related, oftentimes, it's 'head-trash' that keeps them from hitting the mark. How do you re-energize your team to meet and exceed sales goals? Melody Brooke brings a unique more...