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The Regulatory Compliance Almanac is a comprehensive guide to the myriad regulations governing good manufacturing, clinical, and laboratory practices from the FDA, EPA, and the European Union. The Regulatory Compliance Almanac contains in-depth information on: Good Laboratory Practices, Pharmaceutical Good Laboratory Practices, Process Validation, Documentation Requirements, Complaint Investigation, Good Manufacturing Practices, Sanitation Compliance, Medical Device Good Manufacturing Practices, Medical Device Reporting, The Active Implantable Medical Device Directive, The In-Vitro Diagnostic Device Directive, The CE Mark, Animal Welfare, Good Clinical Practices, Milestones in U.S. Food and Drug Law, And much more!
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Les Schnoll is director of quality assurance for Cyberonics, Inc. He has more than 25 years' experience in quality assurance/quality control, auditing, regulatory compliance, management, and microbiology in medical, pharmaceutical, clinical, industrial, and food areas. He is knowledgeable in all aspects of medical device and material, pharmaceutical, food, clinical laboratory, and chemical industry objectives. Schnoll is authorized by the Medical Device Agency in the United Kingdom to perform assessments to the Medical Directive and the EN 46000 standards.
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Book Description Paton Pr, 2001. Hardcover. Condition: New. Never used!. Seller Inventory # P110965044564