QARACC PRODUCTS

  PRINT OR DOWNLOAD A PRODUCT CATALOG

  (CD-ROM) TRAINING MODULES

  INFORMATIONAL HANDBOOKS

  QUALITY SYSTEMS DOCUMENTATION

(CD-ROM) TRAINING MODULES

QARA Compliance Connection has developed a number of highly effective quality system training modules for the medical device and manufacturing industries.  These modules are designed to reduce the time, cost and headache associated with developing internal training programs to meet mandated Quality Management System requirements.

The QARACC training modules eliminate the time, expense and scheduling difficulties associated with off-site employee training and provide you with the scheduling flexibility and convenience you require.  The training modules are ideal for both large and small companies and can be taught by an instructor or used for personalized computer based training using a comprehensive and easy to understand training manual.

Each module includes:
* CD-ROM of the Acrobat training presentation
* Instructor's/Training Manual
* Comprehension Exam
* 3-per-page Master Presentation Handout

Available Training Modules:

  ISO 9000:2000 Quality System Requirements

  FDA Quality System Regulation (QSR)

  Internal Quality System Auditing

  Design Controls - An In-Depth Perspective

  ISO 13485:2003

  Complaint File and Medical Device Reporting
     Requirements

  Root Cause Analysis & CAPA

  QMS Requirements Training

Training module previews are in Adobe Acrobat^® PDF format or in HTML. You will need the Acrobat reader program to view PDF presentations. Click on Acrobat^® reader to download the program free of charge.

INFORMATIONAL HANDBOOKS

QARACC offers a number of informational handbooks on various topics. These books are either 5 1/2 in x 8 1/2 in or 8 1/2 in x 11 in. These handbooks are ideal for all members of your organization or regulatory compliance team.

Available Handbooks:

  Formal Design Reviews
      Click for Table of Contents

  Medical Device Regulation Basics
      Click for Table of Contents

  Cosmetic Regulation Handbook
      Click for Table of Contents

  Understanding ISO 9000:2000
      Click for Table of Contents

  The QSR Companion
      Click for Table of Contents

  21 CFR PART 820

 

QUALITY SYSTEMS DOCUMENTATION

  FDA QSR QUALITY MANUAL

  FDA QSR AUDIT CHECKLIST