This conference is intended to discuss US FDA Quality System Regulation (QSR). In particular, it is intended to talk about what every executive and senior manager must know. The current Good Manufacturing Practice (cGMP) requirements for medical devices including in vitro diagnostic devices (IVDs) are set forth in the Quality System Regulations (QSRs). The QSRs are promulgated under section 520 of the Food, Drug and Cosmetic (FD&C) Act.
Both domestic and foreign manufacturers are required to establish and maintain a quality system (QS) for the design and production of medical devices intended for commercial distribution in the United States. The quality system regulation helps assure that medical devices are safe and effective for their intended use. The US FDA inspects the operations of device firms to determine compliance with the GMP requirements in the QS regulation. To achieve compliance and to remain compliant with the QSRs, it is critical that executives and managers understand and accurately interpret the applicable requirements.
This conference by Dr. David Lim, PhD, RAC, ASQ-CQA will provide great opportunities for executives and managers to become actionably familiar with the quality system requirements applicable to the firms’ device types with improved awareness including the importance of good employment practices and employees’ engagement. David will share his PASS-IT recommendation/suggestions.
Who Should Attend:CEOs
Dr. David Lim, Ph.D., RAC, ASQ-CQA. Dr. Lim is President and Principal of Regulatory Consulting Firm, Regulatory Doctor (www.RegulatoryDoctor.us). As a leading industry speaker, Dr. Lim frequently presents various topics in areas of FDA regulatory, clinical, quality and regulatory compliance matters in various forums and meetings.