FDA, Good Manufacturing Practices GMP, quality system, QSR, ISO 13485, regulatory consultants, manufacturing development device, drug, diagnostic, combination medical products, 510k, PMA, IDE
book, SOP, standard operating procedure writing examples, document management systems, change control, quality assurance, master batch record, device history, specifications, device, drug Documentation Practices
A complete guide to document development and management for GMP and ISO 9000 compliant industries

by Carol DeSain and Charmaine Vercimak Sutton
Tamarack Associates, LLC - 1998

Documentation Practices demystifies the documentation process and provides an accurate and meaningful understanding of manual document management requirements. It includes comprehensive information about documents, documentation, document management and document systems, and it features specific examples of documents. The knowledge this book provides will minimize the number of documents required to achieve compliance and will help in designing electronic documents, databases, and management systems in the future.

Table of Contents
SECTION 1 - INTRODUCTION
Chapter 1: Introduction
Chapter 2: Documents, Documentation and Document Systems
SECTION 2 - COMMITMENT DOCUMENTS
Chapter 3: Introduction
Chapter 4: Planning Documents: Master Plans and Work Plans
Chapter 5: Regulatory Submission Documents
Chapter 6: Requirements
SECTION 3 - DIRECTIVE DOCUMENTS
Chapter 7: Introduction
Chapter 8: Standard Operating Procedures
Chapter 9: Protocols
Chapter 10: Specifications
Chapter 11: Quality Maintenance and Monitoring Programs
Chapter 12: Product Labeling and Printed Materials
SECTION 4 - DATA COLLECTION DOCUMENTS
Chapter 13: Raw Data and Data Collection Documents
SECTION 5 - DOCUMENT MANAGEMENT
Chapter 14: Document Management
SECTION 6 - DOCUMENTATION AND THE RECORDS OF THE CORPORATION
Chapter 15: Introduction
Chapter 16: Documentation: Processing and Control
Chapter 17: Manufacturing Records for Drugs and Biologics
SECTION 7 - PREPARING FOR THE FUTURE
Chapter 18: Electronic and Optical-based Documents, Records and Documentation Practices

Soft cover book - $80.00:
Electronic copy - $110.00 - (PDF 7270KB):
Chapters:
1-Introduction - FREE - (PDF 53.2KB):

2-Documents, Documentation and Document Systems - FREE - (PDF 77.5KB):

3-Introduction - FREE - (PDF 59.1KB):

4-Planning Documents: Master Plans and Work Plans - $5.00 - (PDF 63.6KB):

5-Regulatory Submission Documents - FREE - (PDF 67.5KB):

6-Requirements - $5.00 - (PDF 50.4KB):

7-Introduction - FREE - (PDF 44.9KB):

8-Standard Operating Procedures - $20.00 - (PDF 112KB):

9-Protocols - $20.00 - (PDF 2400KB):

10-Specifications - $15.00 - (PDF 500KB):

11-Quality Maintenance and Monitoring Programs - $20.00 - (PDF 1880KB):

12-Product Labeling and Printed Materials - FREE - (PDF 46.6KB):

13-Raw Data and Data Collection Documents - $15.00 - (PDF 74.9KB):

14-Document Management - $20.00 - (PDF 75.9KB):

15-Introduction - FREE - (PDF 55.8KB):

16-Documentation: Processing and Control - $5.00 - (PDF 78.3KB):

17-Manufacturing Records for Drugs and Biologics - $20.00 - (PDF 2400KB):

18-Electronic and Optical-based Documents, Records and Documentation Practices - FREE - (PDF 75.6KB):


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