Pharmatech

To help provide patients with greater access to safe, effective biological products, the FDA approves biosimilars on an abbreviated pathway. How should you work with the FDA to navigate this pathway?

Maintaining a supply of high-quality product for patients is reliant on the accuracy and completeness of data generated during the development and manufacturing process. Data integrity is critical to ensure that the electronic and paper records we archive and the information they contain retain evidence of the quality of the work performed. This talk discusses data integrity, what it is, and how to implement a robust data integrity program.

Our journey from compliance to quality is rooted in deep traditions, but are those traditions helping us or hurting us? Focusing solely on inspecting for compliance is not sufficient to prevent drug shortages nor ensure drug quality. This talk discusses the quality management maturity (QMM) model, how to move to a culture of quality, common areas of improvement, what to expect.

For an organization to move to and thrive in a culture of quality involves having consistent, reliable, robust business processes and data that promote continual improvement and deliver on quality objectives. This webinar considers some of the most important aspect of quality management, including techniques to achieve a modern maturity model (QMM). We discuss potential areas of improvement, such as a patient-centricity focus, the accuracy and completeness of data, and how to meet current and future regulatory requirements.

A key element of a biosimilar program includes building a development plan to demonstrate comparability between the proposed product and the selected reference product. What steps should be taken to prepare?