Practical applications of quality risk management

BioProcess International

Volumn 8, Issue 3, 2010, Pages 20-32

  Mire Sluis, Anthony ^a   Ramnarine, Emabelle ^b   Siemiatkoski, Joseph ^c   Weese, Dan ^a   Swann, Patrick ^d   O'Keeffe, Richard ^a   Kutza, Joe ^e   Edwards, Julia ^b   McLeod, Lorna D ^e  

^a AMGEN INC   (United States)

^b GENENTECH INC   (United States)

^c BIOGEN   (United States)

^d CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

^e FDA CDER ^*  (United States)

Author keywords

[No Author keywords available]

Indexed keywords

CLINICAL EVALUATION; DECISION MAKING; DRUG QUALITY; HUMAN; MEDICAL PRACTICE; OUTCOME ASSESSMENT; PATIENT SAFETY; QUALITY CONTROL; REVIEW; RISK ASSESSMENT; RISK MANAGEMENT; RISK REDUCTION; SCORING SYSTEM; STANDARDIZATION; TOTAL QUALITY MANAGEMENT;

EID: 77953472692     PISSN: 15426319     EISSN: None     Source Type: Trade Journal    
DOI: None     Document Type: Review

References (5)

1. ICH Q9: Quality Risk Management. Fed. Reg. 71(106) 2006: 32105-32106; www.ich.org/LOB/media/MEDIA1957.pdf.
2. ISO 14971:2007. Medical Devices: Application of Risk Management to Medical Devices. International Organization for Standardization: Geneva, Switzerland, 2007.
3. ISO/IEC Guide 73:2002. Risk Management: Vocabulary - Guidelines for Use in Standards. International Organization for Standardization: Geneva, Switzerland, 2002.
4. ISO/IEC Guide 51:1999. Safety Aspects: Guidelines for Their Inclusion in Standards. International Organization for Standardization: Geneva, Switzerland, 2002.
5. ICH Q10: Pharmaceutical Quality System. Fed. Reg. 74(66) 2009: 15990-15991; www.ich.org/LOB/media/MEDIA3917.pdf.