Des O'Brien

Engineer 4.0: The Life Science Handbook for Medical Devices and BioPharmaceuticals Des O'Brien

This book is inspired by the move towards Industry 4.0, the Fourth Industrial Revolution representing the technological advances that are transforming the manufacturing industry, in particular the capabilities within Life sciences. While the benefits of big data, automation and machine learning will be self-evident, I believe there is a place for underscoring the important of Good Engineering Practice (GEP), quality and compliance in both medical device engineering and Pharmaceuticals. It is important that advancement are based on sound science with an understanding of historical precedencies and regulatory requirements of medical devices and treatments. As powerful new technologies become more mainstream, above all, engineers and scientists must deliver safe and effective products that meet quality and regulatory expectations. This handbook can serve as a physical asset in an age of cloud -based services and information technology. It is based on over 15 years of experience of working in life science industry. It pulls together current practices, regulatory guidance and industry know-how to provide a concise handbook useful for reference or general guidance purposes. Part 2-GXP & COMPLIANCE-2.1 Good Manufacturing Practices2.2 Data Integrity and Principles of CompliancePart 3-MEDICAL DEVICES-3.1 Device Classification3.2 Design Control3.3 ISO 134853.4 Risk Management 3.5 Test Methods Part 4-PHARMACEUTICALS AND BIOPHARMACEUTICALS-4.1 Facilities 4.2 Utilities4.3 Materials Management4.4 Sterile Manufacturing Operations4.5 Depyrogenation Part 5-VALIDATION- 5.1 Validation Planning 5.2 Equipment & Software Qualification5.3 Process Validation5.4 Packaging Validation 5.5 Cleaning ValidationPart 6-ENGINEER 4.06.1 Medical Devices and Apps 6.2 21 CFR Part 11 -Electronic Records & Signatures6.3 Lean Methodologies6.4 Six Sigma6.5 Polymer Processing6.6 Quality and Engineering Tools