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Frequently Asked Questions (FAQ's)
About the Training Modules


 Why did QARA Compliance Connection develop these modules?

Training is a requirement that all organizations in the manufacturing industry need to address. Having been responsible for training employees in several organizations to meet the requirements of ISO 9001, FDA's Quality System Regulation (QSR), and other standards and areas of compliance, I searched far and wide for training products that would be of assistance. The products I found were less than satisfactory. I spent more time trying to fit these programs into our organizations training program than actually training people. After much time and frustration, I decided to develop my own training modules and I used them to train personnel. Many individuals have commented that these modules are far superior to anything they have seen. What is available now is the result, various quality system training modules tested and refined in actual use, These are the QARA Compliance Connection Training Modules offered today.
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 What makes QARA Compliance Connections modules unique?

QARA Compliance Connection's training modules are proven highly effective quality system training units. They are used successfully today by both large and small organizations. The CD-ROM contained in each module is a complete Adobe Acrobat formatted presentation for that topic. Each module is concise and in an easy to use and understand format. Each module also contains a Training Manual. This manual is an invaluable resource and is a train-the-trainer program in itself. It provides the trainer and/or individual with a detailed explanation of the topics discussed in the module and emphasizes key concepts. The manual includes examples of techniques and tools used in real companies, therefore providing the trainer with examples of practical application, not just theories. A comprehension exam is also included with each module. Completion of the exam not only provides feedback on the effectiveness of the program but also provides an important record of training. QARACC also provides a master copy of the CD ROM presentation that may be used as a handout for participants. These modules are extremely flexible in that they may be used by an organization to train personnel in a group setting (i.e. instructor led training) or for personalized computer based training.
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 Are less expensive training materials almost as effective?

No they are not. Remember as the saying goes, "you get what you pay for!" Bargain training books and materials are often purchased in an effort to save a few dollars. Most less expensive products provide just an outline of the material or re-iterate what you already know. Hours are then spent trying to fit these generalized programs into a specific need and to fill in the gaps the bargain programs left out. Often these less expensive products that promised great things end up in your drawer or on your bookshelf collecting dust. Does that sound like a bargain to you? In today's economy, it is even more important that you make smart purchases. Also consider this: the time and money you would spend to develop a similar module yourself is far greater than the one-time cost of QARACC's modules. QARACC's modules are comprehensive and the presentations are in simple easy-to-understand terms. They will make your job easier, more professional and highly cost effective.
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 What training modules are currently available?

QARA Compliance Connection offers a number of highly effective quality system training modules. They include:

  • FDA QSR Training
  • FDA QSR Executive Overview
  • FDA QSR Employee Overview
  • ISO 9000:2000 Overview
  • ISO 13485:2003 Training
  • Design Controls - An In-Depth Perspective
  • Internal Auditor Training (with QSR Audit Checklist)
  • Complaint File & MDR Requirements Training
  • Root Cause Analysis & CAPA
  • QMS Requirements Overview

QARACC is constantly developing new modules and other new materials. Many of our informational handbooks provide great supplements to our modules or any training program. If we don't yet have what you need let us know. Simply email your suggestions and comments to info@qaracc.com.
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 Why are there three different QSR modules?

We developed three distinct QSR training modules because every organization typically has three distinct groups of individuals. First, there are those individuals who are responsible for developing and implementing a quality management system in accordance with FDA QSR requirements. It is critical that these individuals have a complete knowledge and understanding of the requirements so that they may comply with them. The FDA QSR Overview is for those individuals. Then, there are the executives and upper level management who need to understand what the requirements are in a summary overview. These managers need to know what particular requirements pertain to them and what their role and responsibility for compliance is. The FDA QSR Executive Overview is for those individuals. Last, is the FDA QSR Employee Overview. This module is for those individuals in the organization who need a general knowledge and understanding of the requirements. They may or may not have an active role in developing the system but they certainly need to comply with it. It is an excellent first training or orientation for new employees. em but they certainly need to comply with it.
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 What does the training module include?

  • CD-ROM of the Acrobat formatted training presentation (runs on a pc using Windows 98 or higher)
  • Training Manual (used to train-the-trainer or for individual computer based training)
  • Comprehension Exam (tests comprehension and provides a documented training record)
  • 3-per-page Master Presentation Handout
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 Do you have a demo or trial version of the modules?

You can preview a sample of each presentations' content on our website at www.qaracc.com or request a 2-page brochure that gives even more sample pages including notes pages examples. A demo is available for our FDA QSR Overview Module.
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 Couldn't I develop the modules myself a lot cheaper?

Why spend endless hours trying to understand and develop your own modules when we have already done it for you? The time required to develop your own effective training module would far surpass the one time cost of one of QARACC's modules. Why not spend your valuable time and expertise implementing the training and the quality system rather than at the drudgery of writing training materials
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 Can the modules be customized to meet our organizations specific training needs?

Although we have tried to provide materials that are authoritative and comprehensive it is impossible to anticipate every situation in a single publication. So QARA Compliance Connection would be happy to work with you to customize your modules to meet your organizations specific training needs. Customization is at an additional cost. Please call, write or email us with your requirements and we will provide you with a free cost estimate.
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