Course description
FDA Inspection Readiness Training
Understanding what to expect during an FDA inspection enables a medical device manufacturer to prepare effectively for an FDA inspection. This course is designed to meet the needs of domestic and foreign medical device manufacturers doing business or intending to do business in the United States.
This course focuses on identifying and understanding FDAs inspection criteria, resources (including key standard operating procedures such as CP 7382.845), and practices used to plan and conduct inspections of medical device manufacturers. This course is designed to benefit your organizations quality professionals responsible for managing and facilitating FDA inspections; as well as those responsible for defining, documenting, implementing, and maintaining an effective quality management system.
Upcoming start dates
Suitability - Who should attend?
This course benefits quality professionals responsible for managing and facilitating FDA inspections, as well as those responsible for defining, documenting, implementing and maintaining an effective quality management system.
This course is important for medical device professionals, especially those who conduct or participate in any project and/or quality systems activities.
Training Course Content
- Identify key requirements of FDAs Quality System (21 CFR Part 820) and Medical Device Reporting (21 CFR Part 803) Regulations
- Recognize the intent regarding Regulatory Requirements as described in preamble discussions
- Recognize key similarities and differences between 21 CFR Part 820 and ISO 13486:2016
- Identify inspectional resources used by FDA Investigators
- Identify key elements/focus of FDAs Quality System Inspection Technique (QSIT)
Why choose NSF International, Health Sciences
Trained over 1,300 delegates on our CQI and IRCA certified GMP PQS lead auditor training course
Provided expert health sciences training for over 30 years
More people have become ‘Qualified Persons’ in Europe through our training programme than any other training provider
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