Training Options
Duration: 60 Minutes
Quality Management Systems for Medical Devices and IVDs
Description:
Instructor Profile:FDA states in warning letters "this inspection revealed that these devices are adulterated within the meaning of section 510(h) of the FD&C Act, in that the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation are not in conformity with the current good manufacturing practice requirements of the 21 CFR Part 820…"
This webinar will address the said current good manufacturing practice requirements to help you stay in conformity with 21 CFR Part 820. Understanding cGMP requirements found at 21 CFR Part 820 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 is intended to help you get familiar with the current Good Manufacturing Practice (cGMP) requirements for medical devices including in vitro diagnostic medical devices. This webinar is further intended to provide guidance on the cGMP requirements of the Quality System Regulations (QSRs) found at 21 CFR Part 820, which helps assure that medical devices are safe and effective for their intended use. This 60-min webinar will help you get familiar with the Quality System (QS) regulations and requirements that are necessary to achieve compliance and to remain compliant with 21 CFR Part 820 (cGMP for medical devices and IVDs).
Objectives of the Presentation:
This webinar is intended to help you get familiar with the current Good Manufacturing Practice (cGMP) requirements for medical devices including in vitro diagnostic medical devices. This webinar is further intended to provide guidance on the cGMP requirements of the Quality System Regulations (QSRs) found at 21 CFR Part 820, which helps assure that medical devices are safe and effective for their intended use. This 60-min webinar will help you get familiar with the Quality System (QS) regulations and requirements that are necessary to achieve compliance and to remain compliant with 21 CFR Part 820 (cGMP for medical devices and IVDs).
Objectives of the Presentation:
- US quality system regulations, flexibility, definitions and quality system requirements
- Management responsibility, audits 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) and device master record (DMR)
- Quality system procedures, purchasing controls and servicing
- Inspection, measuring and test equipment
- Process validation
- Corrective and preventive action (CAPA) and complaint files
- Quality requirements for premarket approval (PMA) application
- Case studies and lessons learned
- CEOs
- VPs
- Compliance Officers
- Attorneys
- R&D and Manufacturing Managers
- Managers (RA, QA/QC, CA)
- Consultants
- Contractors and Subcontractors
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- Webinar presentation handouts will be shared in pdf format, a day before live presentation.
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- Use the login details to view recorded webinars.
- Presentation handouts will also be shared in pdf format.
- Access to the recording is valid only till 6 months starting from the date of purchase.
- Get certification of attendance.
