With more than fifteen years of experience in the health industry, Ms. Wisniewski has focused on developing extensive validation skills. Nancy has completed GAP analyses of validation program and documentation, including adequacy of SOPs and protocols. She has conducted mock FDA audits focusing on validation program and protocols; has written Validation Master Plans, has coordinated the establishment of Validation Programs, and drafted equipment SOPs. Recently, Nancy drafted various utility and equipment (including analytical) validation protocols, and assisted with the development of the validation approach/rationale, and protocol set up for a Cell Therapy company. In her work with several pharmaceutical companies, Nancy has applied her expertise to simple and complex projects alike, and has worked with management to ensure company compliance with worldwide validation requirements.
