Pharma Quality Europe, pharmaceutical consulting and computer system validation

Computer system validation, technical qualification, pharmaceutical quality engineering, pharmaceutical laboratory regulation.

Computer validation services are offered to pharmaceutical companies.  Quality services pharma Europe.

Validation: an unconventional review and reinvention', PDA J Pharm Sci Technol., vol. 49, no. 4, pp. 175-179. Akers, J. (1993), 'Simplifiying and improving Process Validation', Journal of Parenteral Science and Technology, vol. 47, no. 6, pp. 281-284. Balogh, M. & Corbin, V. (2005), 'Taming the Regulatory Beast: Regulation vs Functionalism', Pharmaceutical Technology Europe, vol. 17, no. 3, pp. 55-58. Boehm, B. W. (1970), Some information processing implications of air force missions 1970-1980, The Rand Corporation, Santa Monica EMEA (1998), EUDRALEX Volume 4 -  pharmaceutical quality consulting - Medicinal Products for Human and Veterinary Use : Good Manufacturing Practice, European Medicines Agency, London FDA (1983), Guide to Inspection of Computerised Systems (The Blue Book), US Food and Drug Administration, Maryland, USA. FDA (1987), Guideline on general principles of Process Validation, US Food and Drug Administration, Maryland, USA FDA (2002), General Principles of Software Validation; Final Guidance for Industry and FDA Staff, US Food and Drug Administration, Maryland, USA

Pharma events organization, Medical writing and investigators meeting organization.

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Pharmaceutical quality consulting, laboratory regulation.

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