Rising Above the Compliance Challenge
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.
- Lessons learnt from successful QMS implementations in FDA-regulated environments
- Proven approaches for measuring the success and ROI of integrated QMS
- Pitfalls to avoid when implementing enterprise-wide quality and compliance programs
- Evolution of Quality Management as a discipline within the enterprise GRC architecture
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:
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The challenges of complying with the FDA regulations with increasing product proliferation and supply chain complexities
- Emerging role of Quality and Compliance Managers in a changing regulatory environment
- A next generation compliance framework that can span multiple functions like quality, safety, environmental, ethics, sales and marketing
- Adopting a GRC based approach towards FDA compliance
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