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Compliance Handbook for Pharmaceuticals, Medical Devices and Biologics
Posted on 2010-04-14
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Compliance Handbook for Pharmaceuticals, Medical Devices and Biologics edited by Carmen Medina ISBN: 0824740785 English -year 2004- 704pages-pdf-Size:7,78 Mb Whether preparing for regulatory submissions or preapproval, investigator-directed, routin, or foreign inspection, this reference is assured to enhance the facility- and compliance-readiness of any company requiring a strengthened approach to compliance and total quality management. Providing innovative programs for every key quality system within an FDA environment, this guide evaluates critical compliance and quality challenges within the context of FDA expectations, current industry standards, and emerging global trends. Lists the necessary steps for meeting compliance requirements during the drug development process Presents comprehensive approaches for validating analytical methods for pharmaceutical applications Contents 1. Regulatory Submissions 2. Compliance Requirements During the Drug Development Process 3. Validation � A New Perspective 4. Validating Analytical Methods for Pharmaceutical Applications: A Comprehensive Approach 5. The Stability Testing Program 6. Computer Validation: A Compliance Focus 7. Compliance Issues Associated with Cleaning in the Pharmaceutical Industry 8. The Batch Record: A Blueprint for Quality and Compliance 9. Change Management: A Far Reaching, Comprehensive, and Integrated System 10. The Vendor Qualification Program 11. Handling Laboratory and Manufacturing Deviations 12. The Internal Audit Program: A Quality Assessment 13. Pre-Approval Inspections: The Critical Compliance Path to Success 14. International Compliance Issues and Trends 15. Strategic Planning for Compliance and Regulatory Defensiveness 16. Unique and Unprecedented Compliance Challenges in the Biologics Area 17. The Impact of Total Quality Performance on Compliance Link: http://rapidshare.de/files/32211288/CHfPMDaB.rar
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