Table of Contents
Part I: A systematic approach to problem solving
Chapter 1: Framework for continuous improvement
1.3 Routine review of life-cycle documents
1.4 Intervention due to internal observation
1.5 Intervention due to external observation
Chapter 2: Investigations, root cause analyses and CAPAs
2.2 The process of investigation
Chapter 3: The role of critical review in the revision of procedures
3.2 Overview of critical review of SOPs
3.3 Risk assessment and critical review
3.4 Investigating a complex × critical problem
Chapter 4: Working with standard operating procedures (SOPs)
4.2 The process of cleaning and sanitizing of facilities
4.3 An illustrative example of a cleaning and sanitizing SOP
Chapter 5: The design phase of the program improvement model
5.1 The ADDIE model and the program improvement model
5.2 The training module in the larger curriculum
5.3 Outlining the proposed training module
Part II: Designing and developing training materials
Chapter 6: Content development: a new employee orientation program
6.2 NEO and the Employment Life-cycle
6.4 Regulatory overlap and its implications
6.5 Presenting the history of the FDA
Chapter 7: Content development: a continuing cGMP training program
7.2 Regulations call for continuing cGMP training
7.3 Who are the qualified individuals?
7.4 Applicable cGMP requirements
7.5 Logistics of continuing cGMP training
Chapter 8: Content development: qualification of employees
8.2 Regulatory basis for training
8.4 Qualification considerations
8.5 The rationale for qualification
8.6 Disqualification and requalification
Part III: Using the training materials
Chapter 9: Assessing trainee proficiency
9.2 Behavioral objectives in the training module
9.4 Preparing the assessment materials
9.5 Incorporating assessments into the training module
Chapter 10: Pilot implementation
10.1 Pilot implementation and the program improvement model
10.2 Pilot projects in the pharmaceutical industry
10.3 Conditions facilitating implementation
10.4 Obstacles to implementation
10.5 Preparing for a pilot implementation
10.6 Conducting a pilot implementation
10.7 Evaluating a pilot implementation
Chapter 11: Training record-keeping
11.2 Record-keeping requirements
11.4 Tactics of training record-keeping
11.5 The training unit as audience
Chapter 12: Formative evaluation
12.2 Feedback versus research design
12.4 The coexistence of RCT and dissemination of results
Chapter 13: Final implementation
13.2 Scope and impact of FDA regulations
13.3 The typical organizational response