Process Driven Compliance: Driving Lifecycle Quality & Competitive Advantage
23 February 2011
12:00–1:30 pm EST
In an era of increased enforcement by the FDA, optimizing product quality and compliance is more important than ever before. Process-driven compliance uses a proactive approach to align business processes and regulatory requirements, improving and accelerating product performance.
In this RAPS webcast, attendees will learn practical approaches to minimize the risk of non-compliance throughout the product lifecycle, focusing on three key stages:
- R&D: Aligning regulatory compliance with optimized business processes
- Later-Stage Development: Working to optimize compliance during clinical trials
- Post-Marketing: Thriving in the FDA’s new reign of enforcement
A thorough understanding of trends in FDA enforcement will benefit participants’ careers by helping them identify corporate compliance vulnerabilities, develop products that meet regulatory requirements and mitigate postmarket compliance risks.
Learning Level(s): Basic, Intermediate
Learning Objectives
Upon completion of this Webcast, participants should be able to:
- Optimize the chances that the products you develop today will meet the global regulatory requirements of tomorrow
- Review the needs in your own organization for aligning regulatory compliance with business processes
- Identify practical approaches to reduce the risk of non-compliance with clinical trial regulations
- Identify compliance vulnerabilities throughout your product life-cycle
- Raise awareness in your organization about the risks organizations can face when compliance anomalies are discovered by today’s more aggressive FDA
- Mitigate post market compliance risks in a practical and cost effective way
Who Should Attend
Regulatory professionals in all levels including:
- COOs
- Plant managers
- Manufacturing managers
- Quality assurance/cGMP Ccmpliance professionals
- Clinical operations/GCP compliance professionals
Speakers
Brad Dawson is the practice leader in Process Optimization at Quintiles.
Dawson is a seasoned life science management consultant with extensive expertise leading strategic growth initiatives, process improvement and quality systems optimization solutions for biopharmaceutical companies. He delivers solutions focused on the transformation of core business and information management processes from preclinical development through clinical trials, regulatory management, and commercial operations among global life science entities. Specific strategy and operations expertise over the last few years has focused on the pharmaceutical development environment, including the related business process and information management interfaces to discovery, clinical supply and manufacturing. The aim has been to assist R&D operations in improving process understanding to achieve regulatory relief, enhanced product knowledge to improve efficacy and patient safety, improved cross-functional knowledge management to minimize risk and reduce time-to-market, and to assist in the adoption and implementation of new FDA cGMP’s for the 21st Century; including Quality by Design, PAT and Design Space.
Robert A. Rhoades is the practice leader in Quality Systems Consulting at Quintiles.
Within his 32 year career, Rhoades has been a preferred advisor to senior pharmaceutical and medical device executives regarding compliance and its impact on corporate direction and strategy. A skilled practitioner of both the Quality System Regulation (QSR) and the pharmaceutical cGMPs, he has designed and implemented compliance improvement initiatives for major manufacturers in the US, Europe, China and India. Rhoades is often engaged to provide post-Warning Letter guidance and remediation project management to re-establish client credibility with the FDA, as well as to assist manufacturers in proactively designing quality systems to assure successful inspections. Rhoades has also worked in concert with client counsel on a wide variety of legal cases. He has designed and executed quality systems programs for client companies resulting in foreign facility approvals by the FDA in China, Germany, Indonesia and Ireland.
Cost
Live Webcast Only: Members: $295 USD; Nonmembers: $369 USD
Webcast On-demand Recording Only: Members: $295 USD; Nonmembers: $369 USD
Live Webcast/On-demand Bundle: Members: $395 USD; Nonmembers: $469 USD
Cost is per site - unlimited participants!