traceable calibrations, FDA regulations, FDA regulation training, FDA pharmaceutical regulation, 21 CFR Part 820, calibration standards, ISO calibration, FDA cGMP regulations, FDA compliance, FDA cGMP, paperless records, 21 CFR Part 11, calibration procedures, calibration traceability, quality calibration program, a paperless calibration department that meets biotech, pharmaceutical, and medical device reqirements, paperless calibration compliance for national and international standards and regulations, virtual calibration workshops

ISBN 978-1-4507-3546-9

From the back cover:

As a calibration professional, have you ever been told the following by your manager, QA auditor or FDA inspector?

•      All of our calibrations are traceable to NIST

•      If test equipment 'As Found' readings were within tolerance then calibration is not required

•      Check the accuracy of a measuring instrument against national (NIST) or international (ISO) standards

•      If the test instrument cannot be adjusted or aligned, it cannot be calibrated

 

These are all incorrect, untrue, false, legends, myths and lies!!

 

This book corrects the misconceptions that have been around for decades due to ignorance and lack of understanding and education on the part of new and old calibration practitioners. Find out the true meaning of calibration and traceability, and where it 'says that'. Discover the five simple steps to meet ISO 9001 & ISO 13485 standards and the FDA requirements for calibration compliance.

See what the requirements really state, and understand how to turn your system into a quality calibration program with best practices and lessons learned. As an extra bonus, included is the step by step program on how to design and create your own electronic forms to replace your hard copy templates, while meeting 21 CFR Part 11 requirements. Be truly paperless for minimum cost and effort.

Hardcopy is in 8.5" x 11" format. There are 8 chapters with 91 figures and illustrations, with acronyms, a glossary, references, an index,

and two attachments (NIST SP 811 & NIST SP 1038) in an easy to read format that is covered in 303 pages.


 ISBN 978-1-4507-3546-9    PCCFNISR
 In Hardcover, Full Color for only $169.95, plus $15.00 shipping & handling (sent priority mail) anywhere in the USA. At this time we accept Check, Money Order, Purchase Order (by emailing us) and PayPal (they accept credit cards).

ISBN 978-1-4507-4908-4    Paperless Calibration Compliance-Spiral bound

A spiral bound, soft cover version in Full Color for only $139.95, plus $15.00 shipping & handling (sent priority mail) anywhere in the USA. At this time we accept Check, Money Order, Purchase Order (by emailing us) and PayPal (they accept credit cards).