Quality Assurance

Part 1 A systematic approach to problem solving: Framework for continuous improvement; Investigations, root cause analyses and CAPAs; The role of critical review in the revision of procedures; Working with standard operating procedures (SOPs). Part 2 Designing and developing training materials: The design phase of the program improvement model; Content development: A new employee orientation program; Content development: A continuing cGMP training program; Content development: Qualification of employees. Part 3 Using the training materials: Assessing trainee proficiency; Pilot implementation; Training record- keeping; Formative evaluation; Final implementation.

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

Quality assurance professionals in regulated industries, with a particular focus on the US Food and Drug Administration (FDA) regulations and guidelines