Compliance Handbook for Pharmaceuticals, Medical Devices and Biologics edited by Carmen Medina

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Compliance Handbook for Pharmaceuticals, Medical Devices
and Biologics


edited by Carmen Medina

 

666 Pages

 

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

Index

 

 

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