| Description |
1 online resource (497 pages) |
| Contents |
Cover; Half Title; Title Page; Copyright Page; Dedication; Table of Contents; Preface; Acknowledgments; Authors; 1: Introduction to Biotechnology Operations: Planning for Success; Biotechnology Operations; Marketing, Financial, and Business Considerations for Development; Product Development Planning; Rationale for Product Development Planning; The Targeted Product Profile; The Product Development Plan; Clinical Development Planning; Project Management Planning; Regulatory Planning; Nonclinical Planning; Biomanufacturing Planning; Quality Control Planning |
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Quality Systems and Quality Assurance PlanningAdditional Elements of Product Planning; Summary of Planning for Success; 2: Project Management; Biotechnology and Project Management; Background of Project Management; Project Management Plan; The Project Management Environment; Project Objectives and Schedules; Sociotechnical Considerations; Participants in Project Management; Project Management in Biotechnology Operations; Establishing Project Management; The Work Breakdown Structure; Forming a Project Team and Hands-on Project Management; Team Dynamics; Communication and Feedback |
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Project Risk Assessment and ManagementMetrics and Tracking Progress; Resources: Planning and Usage; Human Factors in Project Management; Project Completion; Project Management with Contracts and Collaborations; Virtual Teams; Tools for Effective Project Management; Summary of Project Management in Biotechnology Development; 3: Regulatory Affairs; The U.S. Food and Drug Administration: Law and Regulations for Biopharmaceuticals; Historical Basis for FDA Regulation; Regulatory Organization of the FDA; Food and Drug Law, Regulation, and Guidance; FDA-Regulated Products; Biologics; Drugs |
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Medical DevicesCombination Products; Other Classes of Biotechnology Products and Their Review at the FDA; Products for Veterinary Use; Cosmetics, Food, Dietary Supplements, Homeopathic, or Nutritional Products; FDA Regulatory Information and Resources: Regulatory Intelligence; Regulatory Operations for FDA Applications; Regulatory Planning and the Regulatory Environment; Risk Versus Benefit; Applications Seeking FDA Investigational Use or Marketing Approval; Investigational Use Applications. The Investigational New Drug Application; Common Technical Document; Electronic Submission of a CTD |
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Marketing Applications: BLA and NDAMedical Device Applications. 510(k) and PMA; Special Documents, Pathways, or Exemptions; Generic Drugs and Biosimiliar or Follow-on Biologics; Other Regulatory Activities; Public Meetings and Advisory Committees; Postmarketing Requirements and Activities; Advertising and Promotion; Summary of Regulatory Affair Activities in Biotechnology Operations; References; 4: Regulatory Compliance; Regulatory Compliance; Quality Systems to Meet Regulatory Compliance; Compliance and Quality Systems; Current Good Manufacturing Practices for Manufacture and Quality Control |
| Notes |
Current Good Laboratory Practices for Nonclinical Laboratory Studies |
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Print version record |
| Form |
Electronic book
|
| Author |
Roy, Michael J
|
| ISBN |
9781498758864 |
|
149875886X |
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