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This comprehensive resource covers product change evaluation, postmarket surveillance, audit/inspection compliance, and various other laws and regulations pertaining to maintaining a product on the market.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
Section I: Quality Management Systems
Chapter 1 Setting up a Quality Management System
Chapter 2 Medical Device Quality Management Systems
Chapter 3 Canadian Medical Device Quality System Requirements
Chapter 4 Quality Systems and Inspectorate Process for Pharmaceuticals
Chapter 5 Regulatory Requirements for Design and Process Validation
Chapter 6 Quality Risk Management—A Gateway to Quality by Design
Chapter 7 Product Lifecycle Management Guidance
Section II: Laboratory Testing
Chapter 8 Good Laboratory Practice for Nonclinical Laboratory Studies
Chapter 9 Nonclinical Laboratory Testing
Chapter 10 Medical Device Preclinical Testing
Chapter 11 Preclinical Testing and Good Laboratory Practice Regulations
Chapter 12 Good Laboratory Practice Regulations
Section III: Production
Chapter 13 Manufacturing
Chapter 14 Current Good Manufacturing Practices and Quality System Design
Chapter 15 Canadian Good Manufacturing Practices and Establishment Licensing
Chapter 16 Impact of Good Manufacturing Practices on Printed Packaging Components
Chapter 17 CMC Regulatory Strategy
Chapter 18 Fundamental Principles for Labeling and Promotion of Prescription Medical Products
Section IV: Clinical Studies
Chapter 19 Clinical Trials, Good Clinical Practice, Regulations, and Compliance
Chapter 20 Canadian Clinical Trial Applications, Good Clinical Practices
Chapter 21 EU Clinical Evaluation and Clinical Investigations
Chapter 22 Clinical Trials: GCPs, Regulations and Compliance for Drugs, Biologics and Medical Devices
Section V: Inspection, Compliance, and Enforcement
Chapter 23 Compliance and Enforcement
Chapter 24 FDA Inspection and Enforcement
Chapter 25 Components of a REMS: Communication Plans and Implementation Systems
Chapter 26 Components of a REMS: Elements to Assure Safe Use
Chapter 27 Components of a REMS: REMS Assessment
Chapter 28 Risk Management in the Medical Device and Food Industries
Written by dozens of global QMS experts, this easy-to-use e-book presents information necessary to continually evaluate processes to improve business operations, increase efficiency, and ensure compliance with standards and regulations. Quality Management Systems for Drugs and Devices provides key considerations to successfully define, plan, and implement a quality management system in your organization. This QMS e-book encompasses the diversity of expertise necessary to address QS for the various applications within medical device and pharmaceutical development.