Overview of FDA Regulatory Compliance for Medical Devices
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Course Fee
$2150.00 Regular Registration
$1950.00 Early Bird Pricing (Register 30 Days in Advance)
Course Brochure
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Future Live Stream Sessions (click to register)
Course Description
Understanding current Good Manufacturing Practices (cGMP) is critical to the success of any device manufacturing program. In the US, this requires compliance with FDA’s 21 CFR Part 820, the Quality System Regulation (QSR). But manufacturing alone may no longer be enough for the success of your device program because the requirement for clinical validation and clinical data is increasingly required in the global market. Recent regulatory changes in the European Union and pending changes in Canada are evidence of this evolution.
This course provides an overview of 21CFR Part 820, the QSR, and offers insights into how you may generalize the concepts of a Quality System to the clinical validation activities that may be necessary for your product’s development and approval in the US and beyond. We’ll discuss the FDA's regulatory authority for clearing and approving medical devices prior to marketing and the compliance programs used in enforcing its authorities during the manufacture and post-marketing reporting systems. FDA’s inspection of manufacturing facilities and the Office of Bioresearch Monitoring’s (BiMo) inspections of clinical research activities will be reviewed.
The course provides the attendees with the most important regulatory resource materials needed to understand agency policies and enforcement actions as well as strategies for inspection readiness.
Issues to be covered include:
- Structure of the FDA and current FDA regulatory compliance practices
- How to work with the FDA and the field investigators
- The regulatory approval process – "what the FDA is looking for" in 510ks, PMAs and other pre-approval applications
- A review of the Investigational Device Exemption (IDE) process, including significant and nonsignificant risk devices and device classification
- The scope of FDA's compliance programs, policies and potential enforcement actions
- Discussion of post-marketing notification and reporting programs
- Strategies for development of an in-house compliance program which ensure successful inspectional outcomes
- Recent FDA enforcement statistics
Who Should Attend
This 15-hour training course has been developed for those who are involved with ensuring regulatory compliance for medical devices. The course is primarily geared towards those who are new to industry or require a basic understanding of medical device regulatory compliance issues. This medical device compliance training may be of interest to industry veterans who need refresher training on these topics.
Typical FDA regulatory compliance course attendees include those in:
- Manufacturing
- Regulatory Affairs
- Product Design, Research and Development
- Quality Assurance & Control
- Medical/Marketing Personnel
- Management of Medical Device Operations
FAQs
Related Courses
- Comprehensive Overview of FDA Regulatory Compliance for Drug and Biotech Product
- Design Control for Medical Device Professionals
- Integration of Risk Management Principles and Activities into the Quality System
- Medical Device Process Validation Training for Professionals
- Medical Devices: Developing Effective Post Market Surveillance and Complaint Handling Systems
Registrant Information:
Each person attending a course will be asked to set up an Attendee Profile Account during the registration process. Creating an Account helps you view your order history and manage your training programs. If you are registering for others, please set up an Account in the Attendee’s name. If you are registering more than one person, you’ll need to set up a separate account for each Attendee.