Good Documentation Practices and Quality Assurance

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Establishing and maintaining a robust documentation system is critical to achieving regulatory compliance in the biotechnology industry. Participants in this one-day course will learn how to develop, organize, and store documents as part of a Quality Management System. Additional topics to be covered include documentation types and their specific applications, document features that provide objective evidence for activities performed (or results achieved), document control, employee training on documents, document review, approval, and revision, template designs, and practice creating documents such that they may be accurately utilized for their intended purpose.

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