Documentation Practices A complete Guide to Document Development and Management for GMP and ISO 9000 Compliant Industries

 
9780975477229: Documentation Practices A complete Guide to Document Development and Management for GMP and ISO 9000 Compliant Industries

Documentation Practices demystifies the documentation process and provides an accurate and meaningful understanding of manual document management requirements. It includes comprehensive information about documents, documentation, document management and document systems, and it features specific examples of documents. The knowledge this book provides will minimize the number of documents required to achieve compliance and will help in designing electronic documents, databases, and management systems in the future.

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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’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.

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