A Comprehensive View of FDA Regulations for Medical Devices
Dan O'Leary, President at Ombu Enterprises, LLC
Coming soon.. Please contact customer care for new schedule
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
Seminar Fee Includes:
USB with seminar presentation
Hard copy of presentation
$100 Gift Cert for next seminar
- 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
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
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.
|Day One (8:30 AM - 4:30 PM)
||Day Two (8:30 AM - 4:00 PM)
Registration Process: 8:30 AM – 9:00 AM
Session Start Time: 9:00 AM
- Legal and Regulatory Organization
- 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
- 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
- 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
- Sterilization Process Controls
- Sterilization methods
- Sterility Assurance Level (SAL)
- Sterilization as a validated process
- Material Controls
- 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
- 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
Meet Your Instructor
President at Ombu Enterprises, LLC
Dan O'Leary has more than 30 years of experience in quality, operations, and program management in regulated industries including aviation, defense, medical devices, and clinical labs. Mr. O’Leary has a Masters Degree in Mathematics, focusing on logic and number theory. His professional experience relates to quality, regulatory, reliability, and operations management.
He is a regular speaker at international conferences including ASQ, ISM, and RAMS. Dan teaches courses in reliability methods, medical device regulations and practices, statistical methods, management systems (ISO 9001, FDA QSR, & ISO 13485), and project management. He is an ASQ Certified Biomedical Auditor, Quality Auditor, Quality Engineer, Reliability Engineer, and Six Sigma Black Belt; he holds an APICS certification in Resource Management.
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