Don’t let a common misunderstanding get you into trouble! There is more to the US Medical Device Regulations than Part 820.
Companies that don’t understand will face regulatory scrutiny and receive FDA Form 483s and Warning Letters. Recently a device manufacturer got a Warning Letter relating to updates to shipped devices, which said, “The Quality Manager stated he was unaware of the corrections and removal reporting and recordkeeping requirements.”
This two day interactive course on FDA regulations for medical devices will:
- Cover more than just the Quality Management System
- Provide an overview of regulations and how they fit together
- Explain Unique Device Identification (UDI) in detail, covering the issues device manufacturers will face as well as timeline for implementation
- Help attendees understand the four major elements of the US regulatory structure: laws, regulations, guidance, and consensus standards
- Teach the current device marketing regulations
- Discuss how to handle FDA inspections and effectively respond to inspectional observations and 483s
Learning Objectives:
- Learn the law, regulations, and policies that FDA applies for medical device
- Understand the requirements to market a medical device in the US including device classification and conformity assessment paths
- Understand the quality management systems that govern the design, manufacture, installation, and servicing of medical devices for the US market
- Learn how UDI will affect medical devices and how to prepare for implementation
- Understand the rules for Medical Device Reports (MDRs) and their relationship to complaints
- Understand which devices must be tracked and how to set up and audit the system
- Learn about correcting devices already shipped and when to report to FDA
- Learn the role of FDA Inspections, the use of QSIT, and the possible outcomes of an inspection
- Learn about inspectional observations and how to respond to a Form 483
- Understand the issues manufacturers face by reviewing Warning Letters related to the topics covered
In-Person Seminar going Virtual with increased learner satisfaction.
Yes, attend this seminar from anywhere. We are making it real and more interactive – Here's a sneak peek:Our enhanced delivery process and technology provides you an immersive experience and will allow you to access:
- The real-time and live presentation as in in-person events
- Private chat for company-specific conversation – the same as you would get in an in-person seminar
- Opportunities to connect with your peers to share knowledge at a different time and have group discussions
- Live workshop activities
- Live Q&A during the event and offline Q&A assistance after the event
- As usual more content, activities and case studies and now adding homework for a comprehensive understanding
- Certification
Who will Benefit:
This seminar course will be beneficial for the following personnel in medical device manufacturing companies and in medical device supply chain:
- Quality managers
- Quality engineers
- Quality assurance and quality control
- Regulatory affairs managers
- Regulatory affairs professionals
- R&D managers
- R&D engineers
- Product design and development
- Operations managers
- Production managers and supervisors
- Manufacturing engineers
- Risk managers
- Complaint system team members
- CAPA team members
- Device marketing personnel
Topic Background:
In the US, medical devices organization uses risk classes and panels. Devices fall under regulations and product codes that determine the available conformity assessment paths and provide requirements for specific cases.
The Quality System Regulation, in Part 820, provides the quality management system required for medical devices in the US. Device design, production, installation, and servicing fall under Part 820. This part of the regulations include management responsibility for the system, design requirements, purchasing, manufacturing processes and controls, release for distribution, record keeping, etc. After release, a device is subject to a variety of other requirements ranging for complaint management to medical device reports to recalls. Each of these requirements is in a separate part of the regulations.
This two day highly interactive seminar will provide attendees a comprehensive view of the U.S. medical device regulatory requirements and will help them understand the whole picture and provide them with the effective implementation techniques for their organizations.
- Legal and Regulatory Organization
- Laws
- Regulations
- Guidance
- Recognized Consensus Standards
- FDA Organizational Structure
- Medical Device Classification
- Device Classes
- Device Panels
- Device Regulations
- Product Codes
- Premarket Activities, Registration, and Listing
- Clearing devices, the 510(k) paradigm
- Approving devices, the PMA paradigm
- Establishment registration
- Device listing
- Management Controls
- Quality Policy and Objectives
- Management Review
- Internal Quality Audits
- Design Controls
- Input
- Output
- Design Verification
- Design Validation
- Risk Management
- Design Review
- Design Records
- Corrective and Preventive Actions
- Distinguish among Correction, Corrective Action, and Preventive Action
- Applying statistical methods to reveal issues
- Implementation
- Medical Device Reports (MDRs)
- Linking Complaints and MDRs
- When to report
- What to report
- Corrections and Removals
- What they are
- When to report
- When to keep records, but not report
- Medical Device Tracking
- Determining if a device is tracked
- Maintaining the database
- Auditing the database
- Unique Device Identification
- The regulation
- Implementation issues
- Production and Process Controls
- Control of IM&TE
- Equipment maintenance
- Process validation
- Software in production and the QMS
- Material Controls
- Purchasing
- Handling and Storage of Material
- Records, Documents, and Change Controls
- Device Master Record
- Device History Record
- Quality System Record
- The records FDA Investigators should not examine
- General Records
- Maintenance of Record
- Record Retention Period
- Storage of Record
- Electronic Records
- The role of Part 11
- Practical issues from the guidance document
- Statistical Techniques
- Determining and documenting statistical techniques
- Special considerations for sampling plans
Stephanie Harrell
Consultant, ProPharma Group
(Ex-FDA Investigator)
Stephanie Harrell, B.S. has more than 13 years of experience in combined Food and Drug Administration (FDA) regulated industry inspections and consulting with experience in both the pharmaceutical and medical device industries including supplier audits. Ms. Harrell has both conducted and provided training on such topics as managing quality systems, regulatory inspections and audit preparation. She is an ex FDA investigator and speaker at numerous FDA regulated industry conferences. She also has an extensive background which includes healthcare industry consulting and training. Stephanie is passionate about contributing her knowledge to companies for the preparation skills needed for FDA inspections and has a teaching style that is interactive to bring the information to life and help learners generalize information across their various roles and jobs.
