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SPC
for the Rest of Us:
A Personal Path to Statistical Process Control
by Hy
Pitt, 1994
Published by K.W. Tunnell Publishing Group, 1999
SPC for the Rest of
Us has long been a respected tool at Tunnell trainings. Whether
you're learning SPC for the first time, relearning it the right
way so you can truly use it, or giving yourself a refresher
so you can confidently travel forward to Six Sigma, this book
can help. It takes the fear out of numbers, leaves out the intimidation,
and presents a series of learning steps that gets you relying
on statistics as easily as you've relied on guesswork. One corporate
executive says simply that, "Hy Pitt is the best SPC teacher,
period."
Highlights / You will learn:
• How to sample
• How to understand measures of variability
• How to predict process characteristics
• How to use and interpret Shewhart control studies
• How to use calculators and computers in SPC
• How to learn to speak statistics |
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Compliance Handbook for Pharmaceuticals,
Medical Devices, and Biologics
Edited by Carmen Medina, 2004
Published by Marcel Decker, Inc.
Whether preparing for regulatory submissions or preapproval, investigator-directed, routine or foreign inspection, this book will enhance the facility and compliance-readiness of any company requiring a strengthened approach to compliance and total quality management. Providing innovative programs for every key quality system within an FDA environment, this guide evaluates critical compliance and quality challenges within the context of FDA expectations, current industry standards, and emerging global trends.
Compliance Handbook for Pharmaceuticals, Medical Devices, and Biologics discloses proven strategies and practical recommendations from field insiders that guarantee improved compliance and quality in areas such as method development, computer and process validation, change management, internal auditing, product reviews, and regulatory strategic planning. It presents models for success in personnel training, process validation, SOP compliance, laboratory and manufacturing operations, and vendor qualification. It also introduces the latest interpretation of the FDA's new GMP initiative, illustrates quality assurance systems for durable compliance, and offers programs sure to significantly decrease compliance vulnerability and regulatory liability. |
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