Pharmaceutical and Medical Device Validation by Experimental Design
Pharmaceutical and Medical Device Validation by Experimental Design
1st Edition
Lynn D Torbeck
CRC Press
Published June 26, 2007
Reference - 272 Pages - 67 B/W Illustrations
ISBN 9781420055696 - CAT# H5569
Summary
This title demonstrates how designed experiments are the most scientific, efficient, and cost effective method of data collection for validation in a laboratory setting. Intended as a learn-by-example guide, Pharmaceutical and Medical Device Validation by Experimental Design demonstrates why designed experiments are the most logical and rational approach to use, using realistic case studies, illustrations, and where appropriate, step-by-step protocols and procedures.
Table of Contents
Foreword. Preface. Designing Experiments for Validation and Quantitative Methods. Validation of Chemical Reaction Processes. The Role of Designed Experiments in Validation and Process Analytical Technologies (PAT). Experimental Design for Bioassay Development and Validation. Use of Experimental Design Techniques in the Qualification and Validation of Plasma Protein Manufacturing Processes. Response Surface Methodology of Oral Dosage Forms. The Role of Designed Experiments in Developing and Validating Control Plans. Efficient and Effective Process Development Work: The Key to a Successful Validation Study
- Hospitals and Pharmacies | Fundamental sciences | Community Pharmacy | Selling and Marketing in Pharmacies | Essential Soft Skills | Management | Accounting | Legal affairs | Hospital pharmacy | Clinical pharmacy | Quality Control | Infection control | Storage | Mathematics
- Pharmaceutical Industry | Regulatory Agency Governance | Quality Systems | Laboratory Systems | Infrastructure: Facilities, Utilities, Equipment | Materials and Supply Chain Management | Sterile and Nonsterile Manufacturing Systems | Filling, Packaging, Labeling | Product Development and Technology Transfer | Safety and occupational health | Environmental safety | Pharmaceutical Validation
- Selling and Marketing | Selling skills | Marketing planning | Human Resources | Medical updates | Training skills | Regulatory affairs | Pharmacovigilance | Information Technology
- validation (43) | Cleaning Validation (10) | GMP (8) | Process Validation (8) | Computer System Validation (8) | Equipment Validation (7) | Arabic (7) | Equipment Management (6) | FDA (6) | WHO (5) | Analytical Method Validation (5) | Quality Assurance (3) | manufacturing (3) | formulation (3) | World Health Organization (2) | PIC/S (2) | HVAC (2) | Utilities (2) | synthetic (2) | sterile (2) | Community (2) | Pharmacy (1) | European Medicines Agency (1) | day (1) | management (1)
Powered by Mohamed Atia