Life sciences organizations need to realign their Quality and Compliance Management programs not just to meet FDA regulations and GxP requirements but to rise above the compliance challenge to meet the rising standards of product safety and increasing regulatory vigilance. Successful organizations are adoption an integrated enterprise-wide framework for improving oversight, accountability and efficiency. The panel will focus on best practices to follow, pitfalls to avoid, and success metrics to measure when implementing integrated quality and compliance management strategies, processes and technology.
Emerging Role of Quality and Compliance Managers
Combination of product proliferation, outsourced manufacturing operations, stringent FDA regulatory requirements and rigorous customer requirements has created a need for Quality and Compliance Managers to take a fresh and holistic approach.
Quality, Compliance and Regulatory Affairs Professional are required to look for ways to implement a systematic audit process to increase transparency and efficiency, determine the extent of to which the risk management principles are required to be embedded into the quality management program, implement a systematic and consistent CAPA process to help eliminate non-conformances, which in turn ensures regulatory compliance and cost savings. The panel will focus on: