DATA INTEGRITY AND COMPLIANCE IN PHARMACEUTICAL MANUFACTURING

Accurate and reliable data within pharmaceutical manufacturing is critical for demonstrating the quality and integrity of a product. Leading regulatory authorities including FDA have recently issued various guidance documents and recommendations for confirming data integrity as greater scrutiny is now being applied to products in development, as well as those already on the market. Pharmaceutical companies must take a cross-functional approach to developing data integrity systems that allow for continuous improvement to ensure compliance in manufacturing activities where multiple suppliers, sites, and modes of communication are becoming increasingly complex. This webinar will spotlight the following five key areas companies should consider in developing flexible data integrity systems that ensure compliance in pharmaceutical manufacturing:

• FDA’s current regulatory landscape on data integrity
• Real world examples of data integrity issues on the manufacturing floor and in the laboratory
• Potential enforcement consequences from failing to maintain or investigate data integrity
• How to self-identify and respond to data integrity issues
• Creating a culture of accountability

Speaker:
Arif S. Noorani
Associate
Sidley Austin LLP