cGMPs for Medical Devices, Including In Vitro Diagnostic Devices

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.

This webinar will discuss QSRs, requirements and compliance. This session will familiarize participants with the current Good Manufacturing Practice (cGMP) for medical devices including in vitro diagnostic devices. At the end of the webinar, you will get empowered in a way that you would plan, develop, maintain and implement the relevant procedures efficiently and effectively.

Areas Covered in the Seminar:

• QSRs for medical devices and in vitro diagnostic devices.
• Definitions.
• Flexibility of the QSRs.
• Quality system (QS) requirements.
• Management responsibility and personnel.
• Audits.
• 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.
• Servicing.
• Quality requirements for premarket approval (PMA) application.
• Enforcement actions: case studies.
• Lessons learned.

Who Will Benefit:

This webinar will be valuable for anyone in global medical device industry including, but not limited to, those working on drugs, biologics and in vitro diagnostic devices who are involved in current good manufacturing practices.

The following employees who will benefit include:

• Manufacturing professionals.
• Regulatory affairs (associates, specialists, managers, and directors).
• Clinical affairs (associates, specialists, coordinators, managers, directors and VPs).
• Quality assurance, quality control, and quality systems (associates, specialists, engineers, managers, directors and VPs).
• Research and development (associates, scientists, managers, directors and VPs).
• Product and development (associates, scientists, managers, directors and VPs).
• Site managers, and consultants.
• Contract manufacturing organization (associates, scientists, managers, directors and VPs).
• Contract research organization (associates, scientists, managers, directors and VPs).
• Senior and executive management (VPs, SVPs, Presidents and CEOs).
• Contractors and subcontractors.