Speaker Profile

Alla Teresh

Founder, Document Control Supervisor, Manager

Alla Teresh ASQ CQA, has over 11 years of comprehensive experience in documentation audit and management within the medical device industry. During her practice, she designed and implemented a document control system for a startup company that was audited for and awarded an FDA medical PMA and 510K, CE Mark Approval for distribution in Europe. Her skills include a high level of proficiency in conducting technical reviews and managing quality system documentation.

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Good Documentation Practices for GxP Compliance

Documentation is essential for good science. This is especially true in life sciences where FDA and other health authority regulations impose a special recordkeeping burden. In these industries, documentation serves both the scientific and compliance needs, and Good Documentation Practices (GDPs) are the set of activities that enable you to record your data and hand-written entries in a legible, traceable and reproducible manner.

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