Risk Management Basics [Paperback]

Carol DeSain; Charmaine Vercimak Sutton (Author)

Book Description

Publication Date: January 1, 2000

--> a risk management framework for product development, routine operations, and commercial distribution activities that is anchored in the product safety imperatives of the market and the patient. --> an approach to the investigation of OOS results, deviations, complaints and study failures that protects the technical, trouble-shooting environment required to solve real problems, prevents potential problems, and preserves the business values and priorities of the organization. -->a triage system for information monitoring programs and deviation investigations based on risk to product safety that conserves organizational resources. -->examples of why things go wrong in high technology industries and how accidents-of-management can compromise corporate profit and product safety. -->a new approach to organizational design that supports a product focused quality system and protects the productive core of the corporation from problems and inefficiencies.

Editorial Reviews

About the Author

Carol DeSain Carol DeSain’s consulting services focus on regulatory compliance for biologic, biotech, pharmaceutical, diagnostic, and combination products. She has worked in the industry for more than 25 years, with start-ups, global corporations, contract manufacturers, and allied industries in the U.S. and Europe. Carol helps her clients establish new systems, re-work failing systems, establish policy for global corporations and train management and staff. She is known for her broad knowledge of the industry, a practical, hands-on approach to compliance, interactive and informative training sessions, and for the books she has co-authored on documentation, risk management, validation and product development. Prior to consulting Carol worked in basic research (biochemistry, enzymology, and genetics), product/process development, and aseptic pharmaceutical manufacturing. Charmaine Sutton Charmaine Sutton’s consulting services focus on medical devices, diagnostics, and combination products. She has extensive experience advising medium, small, and start-up medical product developers and manufacturers on a broad range of U.S. Food and Drug Administration (FDA) regulations and EU medical product directives. During her consulting career Charmaine has helped numerous U.S. and European companies develop successful regulatory strategies for product approvals and manufacturing compliance. She helps prepare regulatory submissions (RFDs, IDEs, 510(k)s, PMAs), and leads companies through early collaboration meetings with the FDA. Charmaine designs and analyzes quality systems for FDA/QSR and ISO compliance, assists with post-market compliance matters (inspections, warning letters, removals / recalls, MDR / vigilance reporting), and helps develop quality and regulatory management. Prior to consulting, Charmaine worked in industry and academic research and development. She held technical and clinical, quality, and regulatory management positions in several start-up medical device companies, and conducted applied research at a US national laboratory.

Product Details

• Paperback: 147 pages
• Publisher: Tamarack Associates, LLC (January 1, 2000)
• ISBN-10: 0975477218
• ISBN-13: 978-0975477212
• Product Dimensions: 8.8 x 6.1 x 0.4 inches
• Shipping Weight: 11.2 ounces (View shipping rates and policies)
• Amazon Best Sellers Rank: #3,615,297 in Books (See Top 100 in Books)

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