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cGMPs for Medical Devices, Including In Vitro Diagnostic Devices
Tuesday, June 26, 2012 from 10:00 AM to 11:30 AM (PDT)
Palo Alto, CA
This 90-minute webinar will discuss the current good manufacturing practices (cGMPs) for medical devices and in vitro diagnostic devices.
Why Should You Attend:
To achieve sustainability and to remain sustainable and competitive in medical device markets, it is necessary to establish and follow good manufacturing practices (cGMPs) set out in the quality system regulations (QSRs), which help assure that medical devices are safe and effective for their intended use.
Understanding QSRs and the quality requirements can significantly contribute to achieving compliance fast, resulting in saving significant amount of time and efforts and bringing innovative medical products to the market faster.
Areas Covered in the Seminar:
- QSRs for medical devices and in vitro diagnostic devices.
- Flexibility of the QSRs.
- Quality system (QS) requirements.
- Management responsibility and personnel.
- Design control: design and development planning, design input, design output, design review, design verification, design validation, design transfer, and design changes.
- Design history file (DHF).
- Device master record (DMR).
- Quality system procedures.
- Purchasing controls.
- Inspection, measuring and test equipment.
- Process validation.
- Corrective and preventive action (CAPA).
- Complaint files.
- Quality requirements for premarket approval (PMA) application.
- Enforcement actions: case studies.
- Lessons learned.
When & Where
At ComplianceOnline, we are focused on :
- Enhancing global compliance, creating a world where quality and compliance professionals, regulators, and government agencies come together to help the world comply with the intent and the spirit of laws, policies and mandates, ensuring continuous improvement in global operations, quality & safety.
- Making sure that we are responsible corporate citizens helping our constituents build a more responsible enterprise, one which operates with high quality , under a code of ethics, and with process discipline to ensure greater shareholder returns.
- Keeping things simple and straight forward , so that we all can indeed improve the quality of our processes, our work, our businesses and enhance compliance globally.
- Being inclusive, giving the process experts ( & novices! ), compliance professionals, quality champions, and regulatory agencies a voice so that all of us can contribute and make a difference.