FMDIC Quality Systems Educational Forum: Production and Process Controls

In order to best utilize the FMDIC FDA Quality Systems Educational Forum: Production and Process Controls, we recommend your read the following online references. Portable Document Format (pdf) files require Adobe Acrobat Reader to display and print. Word document (doc) files require Microsoft Word.

Highly Recommended

	Medical Device Quality Systems Manual: A Small Entity Compliance Guide http://www.fda.gov/cdrh/dsma/gmpman.html
	FDA CDRH Device Advice: Good Manufacturing Practices (GMP) / Quality System (QS) Regulation http://www.fda.gov/cdrh/devadvice/32.html

	Guideline on General Principles of Process Validation http://www.fda.gov/cdrh/ode/425.pdf
	General Principles of Software Validation; Final Guidance for Industry and FDA Staff http://www.fda.gov/cdrh/comp/guidance/938.html http://www.fda.gov/cdrh/comp/guidance/938.pdf

	21 CFR 820 - Quality System
	The Good Manufacturing Practice (GMP - Quality System Regulation) Final Rule (Federal Register) http://www.fda.gov/cdrh/humfac/frqsr.html http://www.fda.gov/cdrh/fr1007ap.pdf
	Quality System Regulation - Preamble References http://www.fda.gov/cdrh/dsma/preambleref.html
	QSIT Inspection Handbook http://www.fda.gov/ora/inspect_ref/igs/qsit/qsitguide.htm http://www.fda.gov/ora/inspect_ref/igs/qsit/QSITGUIDE.PDF
	Compliance Program 7382.845 - Inspections of Medical Device Manufacturers http://www.fda.gov/ora/cpgm/7382_845/pdf/7382_845.pdf (327 kb)

GMP Guidance Documents - CDRH Office of Compliance
http://www.fda.gov/cdrh/comp/gmp.html

Optional

Process Validation Guidance for Medical Device Manufacturers, Global Harmonization Task Force
http://www.ghtf.org/sg3/inventorysg3/sg3_fd_n99-10_edition2.pdf

ISO 9001 Comparison to the Quality System

	Comparison Chart: 1996 Quality System Reg vs. 1978 Good Manufacturing Practice Reg vs. ANSI/ISO/ASQC Q9001 and ISO/DI 13485:1996 http://www.fda.gov/cdrh/dsma/133.pdf
	ISO 9001:2000 and FDA Quality System http://www.fda.gov/cdrh/devadvice/ISO9001.pdf

Design Control Guidance for Medical Device Manufacturers
http://www.fda.gov/cdrh/comp/designgd.html
http://www.fda.gov/cdrh/comp/designgd.pdf

Do It By Design: An Introduction to Human Factors in Medical Devices
http://www.fda.gov/cdrh/humfac/doit.html
http://www.fda.gov/cdrh/humfac/doitpdf.pdf

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Contact us with questions or comments about this web site. Copyright © 2004 FDA Medical Device Industry Coalition Last modified: 02/26/10

Contact us with questions or comments about this web site.
Copyright © 2004 FDA Medical Device Industry Coalition
Last modified: 02/26/10