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
The US medical device regulations include Part 820, the Quality System Regulation, but extend far beyond them. In order to understand the regulations, you need to look at more than just the quality management system. This course provides an overview and shows how the parts of the regulations fit together.
The seminar will help you understand the four major parts of the US regulatory structure: laws regulations, guidance, and consensus standards. Risk class and the panels, established by law, characterize medical devices in the US. Device types 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 to market 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 course provides a comprehensive view of the regulatory requirements to help you understand the whole picture and provide effective implementation for your company.
- Learn the law, regulations, and policies that FDA applies for medical device.
- Understand the concepts of pre-market approval 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 the role of FDA Inspections, the use of QSIT, and the possible outcomes of an inspection.
- Understand the FDA's inspection documentation tools including the FDA forms 482, 483, and 484.
- Understand the issues manufacturers face by reviewing Warning Letters related to the topics covered.
- Learn the status of the Unique Device Identification (UDI) rule and considerations for implementation.
Who will Benefit:
All medical device manufacturers and companies involved in the medical device supply chain will benefit from this seminar.
- 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
- Medical/Marketing Personnel
This 2-day course includes the following topics:
- Legal and Regulatory Organization
- Recognized Consensus Standards
- FDA Organizational Structure
- Medical Device Classification
- Device classes
- Device Panels
- Device Regulations
- Product Codes
- Registration, Listing, and Clearance
- Clearing devices, the 510(k) 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
- Design Verification
- 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
- 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
- Status of the regulation
- Implementation issues
Meet Your Instructor
President at Ombu Enterprises, LLC
Dan O'Leary has more than 30 years experience in quality, operations, and program management in regulated industries including aviation, defense, medical devices, and clinical labs. He has a Masters Degree in Mathematics, focusing on logic and number theory. His professional experience relates to quality, regulatory, reliability, and operations management.
Dan 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. Dan 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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What past attendees say
With the simple approach take by Dan, anyone can learn how to complete a successful MDD implementation.
- Quality Specialist, Rochester Medica
Dan OLeary displayed complete and total Mastery of the subject in this presentation, and in his answers to the questions asked from him.
- Quality Manager, Parker Hannifin Corp
I enjoyed Dan's course very much. The Instructor and materials were excellent and the information he taught will be very helpful to my Company.
- Compliance Coordinator, Diagnostica Stago, Inc.
The MDD subject matter was well illustrated by Den by flow chart and graphics. Please keep offering this subject matter.
- Senior Quality Assurance Engineer, NDI Medical LLC
I have attended webinars from ComplianceOnline but this "Live" one was incredible. This seminar was excellent.
- Quality Engineering Manager, ConvaTec Inc.
I like the medical device directive and topic regarding standards. The design of the presentations was appropriate.
- Director of Research and Development, Metrex Research,LLC
It was well organized event by ComplianceOnline. Communication was good. Presenter was very knowledgeable. Practical application of directives, standards, regulations are very helpful.
- Manager, Quality Assurance, Instrumentation Laboratory
It was well organized event by ComplianceOnline with good subject matter and knowledgeable instructor.
- Director of Operations and Quality, NDI Medical LLC
I appreciate the knowledge given at this seminar. Speaker is very experienced and I found good talent here. I am very happy with first class reference sheet.
- Sr. CAPA Specialist, Johnson & Johnson Vision Care Inc
Knowledgeable speaker with great real life examples and discussions.
- Quality Director, Lifecore Biomedical
It was a well organized seminar. It provides trainees a good understanding about the CA-PA process that complies with regulatory standards.
- QA/RA Representative, ResMed Corp
It was my first conference with ComplianceOnline and experience was good. Love the reference material and flash key.
- Quality Assurance, Beckman Coulter
Seminar was very informational with great resources. Topics were covered in depth.
- Quality Assurance, Encoll Corp
Session was very informative. Dan did a great job covering a lot of information, comprehensively, within such a short time of just 2 days. Can't wait to attend my next ComplianceOnline seminar.
- President, Medi-Stim, Inc
Seminar was very informative and helpful.
- Operations Director, Medi-Stim, Inc.
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