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Table of Contents
Section I: Quality Management Systems
Chapter 1 Setting up a Quality Management System. .............................................................................................1
By Abhishek Harde, PMP, RAC
Chapter 2 Medical Device Quality Management Systems. ....................................................................................35
By Gert Bos, MSc, PhD, FRAPS
Chapter 3 Canadian Medical Device Quality System Requirements. ....................................................................47
By Karen Fan, MSc, RAC, Peng, Charles Tam, MBA, and Danuta Zylka
Chapter 4 Quality Systems and Inspectorate Process for Pharmaceuticals.............................................................63
By Siegfried Schmitt, PhD
Chapter 5 Regulatory Requirements for Design and Process Validation. ...............................................................85
By Robert V. Packard and Leo Lagrotte
Chapter 6 Quality Risk Management—A Gateway to Quality by Design.............................................................93
By Peter Schiemann, PhD and Beat Widler, PhD
Chapter 7 Product Lifecycle Management Guidance...........................................................................................105
By Ajay Babu Pazhayattil, Naheed Sayeed-Desta, and Queenia Lee
Section II: Laboratory Testing
Chapter 8 Good Laboratory Practice for Nonclinical Laboratory Studies...........................................................113
By Navneet Sekhon
Chapter 9 Nonclinical Laboratory Testing............................................................................................................121
By Dorota Grabowska, PhD and Peter A. Takes, PhD, RAC, FRAPS
Chapter 10 Medical Device Preclinical Testing. .....................................................................................................135
By Jan-Paul van Loon, MSc, PhD and Gert Bos, MSc, PhD, FRAPS
Table of Contents
Section I: Quality Management Systems
Chapter 1 Setting up a Quality Management System. .............................................................................................1
By Abhishek Harde, PMP, RAC
Chapter 2 Medical Device Quality Management Systems. ....................................................................................35
By Gert Bos, MSc, PhD, FRAPS
Chapter 3 Canadian Medical Device Quality System Requirements. ....................................................................47
By Karen Fan, MSc, RAC, Peng, Charles Tam, MBA, and Danuta Zylka
Chapter 4 Quality Systems and Inspectorate Process for Pharmaceuticals.............................................................63
By Siegfried Schmitt, PhD
Chapter 5 Regulatory Requirements for Design and Process Validation. ...............................................................85
By Robert V. Packard and Leo Lagrotte
Chapter 6 Quality Risk Management—A Gateway to Quality by Design.............................................................93
By Peter Schiemann, PhD and Beat Widler, PhD
Chapter 7 Product Lifecycle Management Guidance...........................................................................................105
By Ajay Babu Pazhayattil, Naheed Sayeed-Desta, and Queenia Lee
Section II: Laboratory Testing
Chapter 8 Good Laboratory Practice for Nonclinical Laboratory Studies...........................................................113
By Navneet Sekhon
Chapter 9 Nonclinical Laboratory Testing............................................................................................................121
By Dorota Grabowska, PhD and Peter A. Takes, PhD, RAC, FRAPS
Chapter 10 Medical Device Preclinical Testing. .....................................................................................................135
By Jan-Paul van Loon, MSc, PhD and Gert Bos, MSc, PhD, FRAPS