1.

Record Nr.

UNINA9910700920203321

Autore

Ribar David Christopher

Titolo

Applying for and staying on the Supplemental Nutrition Assistance Program in South Carolina / / by David C. Ribar and Christopher A. Swann

Pubbl/distr/stampa

[Washington, D.C.] : , : [U.S. Department of Agriculture, Economic Research Service, Food Assistance and Nutrition Research Program], , [2011]

Descrizione fisica

1 online resource (iv, 45 pages) : illustrations

Collana

Contractor and cooperator report ; ; no. 65

Soggetti

Food relief - South Carolina

food and nutrition programs

Food relief

South Carolina

Lingua di pubblicazione

Inglese

Formato

Materiale a stampa

Livello bibliografico

Monografia

Note generali

Title from title screen (viewed on Jan. 27, 2011).

"February 2011."

"This study was conducted by University of North Carolina at Greensboro under a cooperative research agreement with USDA's Economic Research Service (ERS) Food Assistance and Nutrition Research Program (FANRP)."

Nota di bibliografia

Includes bibliographical references (pages 31-32).



2.

Record Nr.

UNINA9910830871703321

Autore

Bliesner David M

Titolo

Establishing a CGMP laboratory audit system [[electronic resource] ] : a practical guide / / David M. Bliesner

Pubbl/distr/stampa

Hoboken, N.J., : Wiley-Interscience, c2006

ISBN

1-280-44808-3

9786610448081

0-470-23938-7

0-471-78478-8

0-471-78477-X

Descrizione fisica

1 online resource (295 p.)

Disciplina

343.7307/86151

542.1

Soggetti

Pharmaceutical industry - United States

Drugs - Law and legislation - United States

Lingua di pubblicazione

Inglese

Formato

Materiale a stampa

Livello bibliografico

Monografia

Note generali

Description based upon print version of record.

Nota di bibliografia

Includes bibliographical references and index.

Nota di contenuto

Preface -- Introduction to the quality systems approach to CGMP compliance -- Preparing for the audit -- Auditing and data capture -- Organizing data and reporting the results -- Developing and implementing a corrective action plan -- Developing and implementing a verification plan -- Developing and implementing a monitoring plan -- A summary for establishing a CGMP laboratory audit system -- Appendixes -- Example audit checklists: laboratory subelements -- Example template for an audit summary report -- Glossary of CGMP and audit system terms -- FDA compliance program guidance manual 7356.002 "Drug manufacturing inspections" -- 21 Code of U.S Federal Regulations parts 210 and 211 current good manufacturing practice regulations.

Sommario/riassunto

The first systematic, hands-on auditing guide for today's pharmaceutical laboratoriesIn today's litigious environment, pharmaceutical laboratories are subject to ever stricter operational guidelines as mandated by the FDA, and must be able to establish and demonstrate sustainable operational practices that ensure compliance



with the current good manufacturing practice (CGMP) regulations. David Bliesner's Establishing a CGMP Laboratory Audit System: A Practical Guide is designed to provide laboratory supervisors and personnel with a step-by-step, hands-on audit system that they can rely