The regulatory compliance almanac
Subtitle: a guide to good manufacturing, clinical, and laboratory practices
By: Les Schnoll.
Publisher: Paton Professional
Published: 2008
Place of publication: Chico, Calif
Language: eng
ISBN-13: 9781932828191
Subjects: Food law and legislation -- United States; Drugs -- Law and legislation -- United States; Medical instruments and apparatus -- Law and legislation -- United States; Laboratories -- Safety regulations -- United States; Laboratory animals -- Law and legislation -- United States
Notes: Includes index.
Table of contents: title: Good laboratory practices; title: Pharmaceutical good manufacturing practices; title: Process validation; title: Documentation requirements; title: Complaint investigation; title: Food good manufacturing practices; title: Sanitation compliance; title: Medical device good manufacturing practices/quality system regulation; title: Medical device reporting; title: The medical device directives MDD-93/42/EEC and AIMD-90/385/EEC; title: The in-vitro diagnostic device directive; title: Animal welfare and the institutional animal care and use committee; title: Good clinical practices; title: Correction and removal reports; title: The basis of risk management; title: The consequences of misconduct in FDA-regulated industries.