American Society for Quality BioMedical Division

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Address: 3160 Porter Drive, Palo Alto, CA 94304

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Programs	Status
NCDG Production and Process Controls The major factors that contribute to GMP-related recalls are post-production problems, poorly characterized manufacturing processes and inadequate or poorly executed process validation. This discussion provides and overview of the laws and guidelines that govern process process validation and production controls, and outlines practicle approach for implementing compliant programs to validate manufacturing processes, implement appropriate controls, and maintain validated states.	Closed

Programs

Status

NCDG Production and Process Controls

The major factors that contribute to GMP-related recalls are post-production problems, poorly characterized manufacturing processes and inadequate or poorly executed process validation. This discussion provides and overview of the laws and guidelines that govern process process validation and production controls, and outlines practicle approach for implementing compliant programs to validate manufacturing processes, implement appropriate controls, and maintain validated states.

Closed

SSL 03/2010