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fdaval.com

Paul Nicholson Consulting Home Page

validation services, quality audits and quality systems support for all aspects of FDA and ISO compliance in the biotech and pharmaceuticle industries.

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Paul Nicholson Consulting

Paul Nicholson

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Paul Nicholson Consulting Home Page | fdaval.com Reviews
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validation services, quality audits and quality systems support for all aspects of FDA and ISO compliance in the biotech and pharmaceuticle industries.
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Paul Nicholson Consulting Home Page | fdaval.com Reviews

https://fdaval.com

validation services, quality audits and quality systems support for all aspects of FDA and ISO compliance in the biotech and pharmaceuticle industries.

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Paul Nicholson Consulting Home Page

http://www.fdaval.com/index.html

N-site IQ,OQ,PQ and Part 11 validations, Quality System Audits and Quality Systems/Regulatory Compliance Support. Providing customer focused services with the attention to detail required in the Biotech/Pharmaceutical industries. 20613 South Yale Ave. Mounds, Oklahoma 74047.

2

Paul Nicholson Consulting Home Page

http://www.fdaval.com/Links.htm

Code of Federal Regulations. FDA Guideline for General Principals of Software Validation. 21 CFR Part 11 Electronic Records/Electronic Signatures Latest Guidance Document. FDA Guideline for Computerized Systems Used in Clinical Trials. FDA Modernization Act of 1997 (FDAMA). FOI, Electronic Reading Room. Center for Biologics Evaluation and Research. Human Drug Current Good Manufacturing Practice Notes. Office of Regulatory Affairs. American Society For Quality (ASQ). DIA - Drug Information Association.

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