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Quality Assurance

Book Description

Quality assurance is necessary to maintain quality and services in the pharmaceutical and life science industries. Quality assurance demonstrates that the logic and practice of problem solving can integrate both program efficacy and regulatory compliance. This title is divided into three parts; the first part discusses the process by which a problem in regulated industry is identified, for example a manufacturing deviation that leads to an adulterated drug product, and reviews the decision-making steps involved in remedying the problem. The second part delves into the staff training requirements of procedures that are thereby revised. The third part expands on this discussion by considering piloting the proposed training module, preparing assessments of trainee proficiency, evaluating the training module, including integrating rigorous evaluative designs with formative program improvement, and documenting the entire effort.

  • Presents a comprehensive view of the field of quality assurance
  • An approach grounded in direct experience
  • Uses diagrams and figures to clarify analytical points

Table of Contents

  1. Cover image
  2. Title page
  3. Table of Contents
  4. Copyright
  5. List of figures
  6. List of tables
  7. List of abbreviations
  8. About the author
  9. Acknowledgments
  10. Part I: A systematic approach to problem solving
    1. Introduction
    2. Chapter 1: Framework for continuous improvement
      1. Abstract:
      2. 1.1 Introduction
      3. 1.2 Procedures and change
      4. 1.3 Routine review of life-cycle documents
      5. 1.4 Intervention due to internal observation
      6. 1.5 Intervention due to external observation
      7. 1.6 Conclusion
    3. Chapter 2: Investigations, root cause analyses and CAPAs
      1. Abstract:
      2. 2.1 Triage and escalation
      3. 2.2 The process of investigation
      4. 2.3 The process of CAPA
      5. 2.4 Conclusion
    4. Chapter 3: The role of critical review in the revision of procedures
      1. Abstract:
      2. 3.1 Introduction
      3. 3.2 Overview of critical review of SOPs
      4. 3.3 Risk assessment and critical review
      5. 3.4 Investigating a complex × critical problem
      6. 3.5 Conclusion
    5. Chapter 4: Working with standard operating procedures (SOPs)
      1. Abstract:
      2. 4.1 Introduction
      3. 4.2 The process of cleaning and sanitizing of facilities
      4. 4.3 An illustrative example of a cleaning and sanitizing SOP
      5. 4.4 Conclusion
    6. Chapter 5: The design phase of the program improvement model
      1. Abstract:
      2. 5.1 The ADDIE model and the program improvement model
      3. 5.2 The training module in the larger curriculum
      4. 5.3 Outlining the proposed training module
      5. 5.4 Conclusion
  11. Part II: Designing and developing training materials
    1. Introduction
    2. Chapter 6: Content development: a new employee orientation program
      1. Abstract:
      2. 6.1 Introduction
      3. 6.2 NEO and the Employment Life-cycle
      4. 6.3 A typical NEO program
      5. 6.4 Regulatory overlap and its implications
      6. 6.5 Presenting the history of the FDA
      7. 6.6 Organizational issues
      8. 6.7 Conclusion
    3. Chapter 7: Content development: a continuing cGMP training program
      1. Abstract:
      2. 7.1 Introduction
      3. 7.2 Regulations call for continuing cGMP training
      4. 7.3 Who are the qualified individuals?
      5. 7.4 Applicable cGMP requirements
      6. 7.5 Logistics of continuing cGMP training
      7. 7.6 Conclusion
    4. Chapter 8: Content development: qualification of employees
      1. Abstract:
      2. 8.1 Introduction
      3. 8.2 Regulatory basis for training
      4. 8.3 Categories of training
      5. 8.4 Qualification considerations
      6. 8.5 The rationale for qualification
      7. 8.6 Disqualification and requalification
      8. 8.7 Conclusion
  12. Part III: Using the training materials
    1. Introduction
    2. Chapter 9: Assessing trainee proficiency
      1. Abstract:
      2. 9.1 Introduction
      3. 9.2 Behavioral objectives in the training module
      4. 9.3 Which kind of assessment
      5. 9.4 Preparing the assessment materials
      6. 9.5 Incorporating assessments into the training module
      7. 9.6 Conclusion
    3. Chapter 10: Pilot implementation
      1. Abstract:
      2. 10.1 Pilot implementation and the program improvement model
      3. 10.2 Pilot projects in the pharmaceutical industry
      4. 10.3 Conditions facilitating implementation
      5. 10.4 Obstacles to implementation
      6. 10.5 Preparing for a pilot implementation
      7. 10.6 Conducting a pilot implementation
      8. 10.7 Evaluating a pilot implementation
      9. 10.8 Conclusion
    4. Chapter 11: Training record-keeping
      1. Abstract:
      2. 11.1 Introduction
      3. 11.2 Record-keeping requirements
      4. 11.3 Part 11 compliance
      5. 11.4 Tactics of training record-keeping
      6. 11.5 The training unit as audience
      7. 11.6 Conclusion
    5. Chapter 12: Formative evaluation
      1. Abstract:
      2. 12.1 Introduction
      3. 12.2 Feedback versus research design
      4. 12.3 The good news, part 1
      5. 12.4 The coexistence of RCT and dissemination of results
      6. 12.5 The good news, part 2
      7. 12.6 Management’s prerogative
      8. 12.7 Conclusion
    6. Chapter 13: Final implementation
      1. Abstract:
      2. 13.1 Introduction
      3. 13.2 Scope and impact of FDA regulations
      4. 13.3 The typical organizational response
      5. 13.4 The role of the target audience list
      6. 13.5 Conclusion
  13. Index