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Product Description
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.
About the Author
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 knowl
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.
About the Author
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 knowl