'System suitability' diaporamas de présentation

GENERAL I.

PREPARING FOR A METHOD VALIDATION Steven S. Kuwahara, Ph.D. GXP BioTechnology, LLC PMB 506, 1669-2 Hollenbeck Avenue Sunnyvale, CA 94087-5042 Tel. & FAX: (408) 530-9338 e-Mail: stevekuwahara@yahoo.com Website: www.gxpbiotech.org. GENERAL I.

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Preventing OOS Deficiencies

Preventing OOS Deficiencies. Lynn Torbeck. List of Topics. Briefly review: Barr Case FDA OOS Guidance Able Laboratories Story PDA Scientific Advisory Board Committees Troublesome fundamentals Unresolved issues Preventing OOS deficiencies Final recommendations. Barr Case.

1.08k views • 65 slides

TOC MEASUREMENT OF PHARMA WATERS

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US & EU GMP Guidelines on Analytical Instrument Qualification and Related Warning Letters

US & EU GMP Guidelines on Analytical Instrument Qualification and Related Warning Letters. Overview. FDA/EU/USP Requirements and enforcement practices Examples of FDA warning letters The 4Q model for equipment qualification

1.6k views • 25 slides

Method Validation

Method Validation. Validation Defination Establishing documentary evidence which provides a high degree of assurance that specification process will consistently produce a product meeting its predetermined specifications and quality attributes. Methods need to be validated or revalidated

591 views • 17 slides

Opsonization from Industry Perspective

260 views • 17 slides