Fran Zipp is President & CEO of Lachman Consultant Services, Inc. As an expert in compliance enhancement, she develops program solutions to meet GXP compliance requirements and delivers strategic guidance and direction toward implementation of effective solutions to client needs. Ms. Zipp has extensive experience in the pharmaceutical, biologic and biotechnology industries from R&D through post-market approval. She assists and counsels Senior-level management in areas of Corporate Governance, Corporate Integrity Agreement Compliance, Consent Decree Negotiations and Resolutions, Application Integrity Policy resolution, and Due Diligence evaluations (facilities; products; technologies).
About her Talk, "Ensuring Data Integrity in Science"
While it is a recent focus of FDA inspections, ensuring the integrity of data is not a new concept for the life sciences. Indeed, in a laboratory, whether basic research-oriented or a quality control laboratory in the pharmaceutical industry, the concepts of controls (both positive and negative) are fundamental to ensuring that one’s observations and interpretations are accurate. In her talk, Ms. Zipp will discuss data integrity from the bench to the bedside, and describe the commonalities that underlie data integrity issues between basic science to commercial scale production in the pharmaceutical industry, as well as ways to ensure that your data has the integrity needed to make progress in life science.