Advanced Quality & Regulatory Symposium: FDA speaker & leading industry experts discuss compliance issues in the drug, device and biologics industry
The 2011 Advanced Quality and Regulatory Symposium for the Biotech and Medical Devices Industry Conference will address the latest regulatory requirements for the development of clinical trials, regulatory submission, and quality systems regulatory requirements for devices, drugs and biologics products.
- Philadelphia, PA-NJ (1888PressRelease) January 24, 2011 - Monarch Quality Systems Solutions, LLC (MQSS) launches their first annual conference at the Radisson Warwick Plaza Hotel, taking place in Philadelphia on April 5-6, 2011. MQSS welcomes you to the premier forum for you to join current and former FDA speakers, as well as leading industry experts in face-to-face dialogues, in effort to attain the most comprehensive, up-to-date information on significant regulatory and compliance issues in the life science industry. Each attendee will review the primary issues involved in the compliance process from the FDA's perspective.
Hear directly from both present and former FDA experts on requirements that are becoming more rigorous in device manufacturing companies. Administer and take home best practices and practical approaches to compliance strategies that can be effectively implemented within your company's daily processes. Discuss current risk-based approaches and understand what Investigators are really looking for and how to comply with emerging regulations, as well as which Quality System requirements are most scrutinized during inspection visits. This conference was designed to provide a comprehensive, cost effective compliance strategy for professionals in the drug, device and biologics industries. This two day event, is designed to provide attendees with a strong foundation for understanding the regulatory requirements of the US FDA as well as MDD/AIMDD. This course is designed to provide participants with an understanding of the current regulatory compliance issues cited in 483s and Warning letters, successful approaches to compliance, and meeting the concerns of regulators. Attendees will leave with a comprehensive set of tools for preparing regulatory initiatives, coping with challenges, and managing compliance.
Expert industry speakers and current and former FDA speakers address practical challenges and enforcement trends through informative and interactive sessions, and Panel discussions including a Questions and answer session.
FDA speaker, CAPT Joseph L. Salyer, RS, MPH, Compliance Officer in the General Surgery Device Branch, Division of Enforcement A, in the Center for Device and Radiological Health will be joined with various leading industry experts from the following companies: Proctor & Gamble, Bayer HealthCare, Pfizer Inc. and other former investigators.
Conference early bird rates end January 31, 2011. For more information and registration, please visit the MQSS website.
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