Welty G. Quality assurance: Problem solving and training strategies for success in the pharmaceutical and life science industries

Woodhead Publishing Limited, 2013. — 360 p.
Quality assurance is necessary to maintain quality and services in the pharmaceutical and life science industries. Gordon Welty demonstrates that the logic and practice of problem solving can integrate both program efficacy and regulatory compliance. This book explains how a problem in regulated industry is identified, reviews the decision making steps involved in remedying the problem and the staff training requirements of revised procedures and offers a proposed training program.Contents
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)
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
Using the training materials
Assessing trainee proficiency
Pilot implementation
Training record- keeping
Formative evaluation
Final implementation