Biomedical Engineering Reference
In-Depth Information
presented in this chapter will help create the foundation and infrastructure the
reader will need to plan and implement a successful risk management program.
REFERENCES
1. EudraLex, The Rules Governing Medicinal Products in the European Union, Volume
4, EUGuidelines to Good Manufacturing Practice, Medicinal Products for Human
and Veterinary Use, Part III, Q9 Quality Risk Management, 2011, p. 1. Available
at http://ec.europa.eu/health/documents/eudralex/vol-4/index_en.htm. Accessed 2011
Dec 26.
2. EudraLex, The Rules Governing Medicinal Products in the European Union, Volume
4, EUGuidelines to Good Manufacturing Practice, Medicinal Products for Human
and Veterinary Use, Part I, Chapter 1, Quality Management, 2008, p. 2. Available
at http://ec.europa.eu/health/documents/eudralex/vol-4/index_en.htm. Accessed 2011
Dec 26.
3. EudraLex, The Rules Governing Medicinal Products in the European Union, Volume
4, EUGuidelines to Good Manufacturing Practice, Medicinal Products for Human
and Veterinary Use, Part I, Chapter 1 Quality Management, 2008, p. 2. Available
at http://ec.europa.eu/health/documents/eudralex/vol-4/index_en.htm. Accessed 2011
Dec 26.
4. EudraLex, The Rules Governing Medicinal Products in the European Union, Volume
4, EUGuidelines to Good Manufacturing Practice, Medicinal Products for Human
and Veterinary Use, Part I, Chapter 1 Quality Management, 2008, p. 2. Available
at http://ec.europa.eu/health/documents/eudralex/vol-4/index_en.htm. Accessed 2011
Dec 26.
5. Davis, Matthew, Office of Manufacturing Quality, Australian Government,
Department of Health and Ageing, Therapeutic Goods Agency (TGA) Qual-
ity Risk Management Audit Expectations and Observations, CAPSIG semi-
nar 'Risk Management within Manufacturing Plants', 4 May 2011 Available
at http://www.tga.gov.au/newsroom/events-presentations-manuf.htm. Accessed 2011
Dec 26.
6. Oemmerance, Sven, GMP News: Evaluation of the Warning Letters issued by the
FDA for the Fiscal Year 2010 with regard to Risk Management, March 9, 2011,
http://www.gmp-compliance.org/eca_news_2450_6764,6917,6971.html.
Accessed
Dec 26 2011.
7. Davis, Matthew TGA, 4 May 2011.
8. Davis, Matthew TGA, 4 May 2011.
9. World Health Organization WHO Guideline on Quality Risk Management, Work-
ing document QAS/10.376/Rev.1 Draft for discussion, August 2011, Available
at http://www.who.int/medicines/areas/quality_safety/quality_assurance/projects/en/.
Accessed 2011 Dec 26.
10. Davis, Matthew, TGA, 4 May 2011.
11. Davis, Matthew, TGA, 4 May 2011.
12. Davis, Matthew, TGA, 4 May 2011.
13. World Health Organization WHO Guideline on Quality Risk Management, Working
document QAS/10.376/Rev.1 Draft for discussion, August 2011, pp. 9-10, Available
at http://www.who.int/medicines/areas/quality_safety/quality_assurance/projects/en/.
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