Validation and the human element

PDA Journal of Pharmaceutical Science and Technology

Volumn 52, Issue 2, 1998, Pages 52-54

  Kieffer, Robert G ^a,b  

^a RGK Consulting   (United States)

^b NONE   (United States)

Author keywords

Empowering Environment; Failure Mode Effect Analysis; Human Element; Process Reengineering; Qualified People; Training; Validation

Indexed keywords

INFORMATION PROCESSING; PROCESS CONTROL; RISK ASSESSMENT; SHORT SURVEY; VALIDATION PROCESS;

DRUG INDUSTRY; PHARMACEUTICAL PREPARATIONS; QUALITY CONTROL;

EID: 0031957187     PISSN: 1076397X     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Short Survey

References (5)

1. G. A. Rummler and A. P. Brache, "Improving Performance, How To Manage the White Space on the Organization Chart," Jossey-Bass Pub., 1990.
2. R. Kieffer and M. E. Diaz, "Reengineering pharmaceutical quality processes: A case study - labeling." PDA Jr. of Pharm. Sci. & Tech., Jan/Feb 1997.
3. R. Kieffer, S. Bureau, and A. Borgmann, "Applications of failure mode effect analysis (FMEA) in the pharmaceutical industry," Pharm. Tech. Europe, Sept., 1997.
4. D. H. Stamatis. "Failure Mode and Effect Analysis," ASQC Quality Press, Milwaukee, Wisconsin, 1995.
5. R. E. McDermott et al., "The Basics of FMEA." Quality Resources, New York, NY, 1996.