Books By Anne (Booth Scientific Inc., Hendersonville, North Carolina, USA) Booth - Author

Anne F.Booth President Booth Scientific, Inc An experienced quality and sterilization professional with an in-depth knowledge of quality systems and sterilization process design, validation, cycle development and routine operation; of environmental monitoring and control and regulatory compliance issues. Detailed knowledge of FDA QSR requirements (21 CFR 820 and 210/211), as well as ISO 13485, ICH, EU MDD and Canadian requirements. Experienced in project and laboratory management. Skilled in process design and validation for a wide variety of medical devices, packaging, and pharmaceutical raw materials. Good troubleshooting, auditing and time management skills. Track record of significant contributions to improved operating efficiency, cost reduction, and profit enhancement. Specialties: sterilization design and validation, quality systems, environmental monitoring, microbiology evaluations and testing, auditing