Engineers are increasingly seeking employment within regulated industries such as Life Sciences. Medical Device Manufacturing and Pharmaceutical Manufacturing provide competitive salaries and generally stable employment. For those who aim to cross over from more traditional forms of engineering, the requirements of cGxP may be unfamiliar and daunting at first.
However, meeting the regulatory requirements is fundamental in allowing the sale and export of products to different markets throughout the globe. Therefore, it is not long before an understanding and competency in cGxP and Validation is required by Engineers, Scientists or Managers.
Now, ValidationResources.org have published a handbook introducing the concepts of cGxP and Validation. The book is entitled "An Introduction to cGxP and Validation for Engineers"
"An Introduction to cGxP and Validation for Engineers" was written to assist Engineers and Professionals in acquiring the fundamental skills and knowledge needed in Medical Device and Pharmaceutical Companies.
The book brings together the Key Principles of Good Manufacturing Practices (GMP), Good Documentation Practices (GDP), Equipment Validation and Process Validation. Case studies based on industry experience are also included, helping the reader to appreciate the practical application of cGxP and Validation.
Click Here to see the hardcopy available.
Click Here to see the Kindle ebook version available at www.amazon.com and www.amazon.co.uk
Chapter 1- An Introduction to GDP
Chapter 2- An Introduction to GMP
Chapter 3- An Introduction to Test Method Validation
Chapter 4- An Introduction to Equipment Qualification
Chapter 5- An Introduction to Process Validation
-Case Studies
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