Understanding and Implementing the Medical Device Directive: 2-Day In-person Seminar
Dan O'Leary, President at Ombu Enterprises, LLC
| Thursday, June 16, 2016 | Friday, June 17, 2016
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 explains how the parts of the regulations fit together. The seminar helps 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 pre-market submission pathways 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 from UDI to complaint management to medical device reports. 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.
Why Should You Attend:
Seminar Fee Includes:
USB with seminar presentation
Hard copy of presentation
$100 Gift Cert for next seminar
People who work in medical devices are not always able to see the complete structure of the regulations and how they fit together. In the US regulatory structure the parts are linked and intertwined. For example UDI implementation is in about six parts of the regulations. Medical Device Reports, in Part 803, must link with complaints in Part 820.
This course provides explains how all of this fits together. Whether you are an experienced professional or a person just entering the field, this seminar provides the information you need to understand and stay current with the US regulatory structure.
- Distinguish among the law, regulations, and policies that FDA applies for medical device
- The concepts of pre-market approval including device classification and pre-market submissions
- The quality management systems that govern the design, manufacture, installation, and servicing of medical devices distributed in the US
- The role of FDA Inspections, the use of QSIT, and the possible outcomes of an inspection
- FDA's inspection documentation tools including the FDA forms 482, 483, and 484.
- Utilization of Warning Letters to understand the regulatory issues
Who will Benefit:
While the course is specific for medical device manufacturers, any company in the medical device supply chain can benefit. It is ideal for:
- Quality Managers
- Quality Engineers
- 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
- CA&PA team members
- Medical/Marketing Personnel
|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
Part A – Legal and Regulatory Organization
- Recognized Consensus Standards
- FDA Organizational Structure
Part B – Medical Device Classification
- Device classes
- Device Panels
- Device Regulations
- Product Codes
Part C – Registration, Listing, and Clearance
- Clearing devices, the 510(k) paradigm
- Establishment registration
- Device listing
Part D – Unique Device Identification
- Effective dates and Compliance dates
- FDA’s database – GUDID
- Implementing the regulations
Part E – Management Controls
- Quality Policy and Objectives
- Management Review
- Internal Quality Audits
Part F – Design Controls
- Design Verification
- Design Validation
- Risk Management
- Design Review
- Design Records
Part G – Corrective and Preventive Actions
- Distinguish among Correction, Corrective Action, and Preventive Action
- Applying statistical methods to reveal issues
Part H – Production and Process Controls
- Control of IM&TE
- Equipment maintenance
- Process validation
- Software in production and the QMS
Part I – Sterilization Process Controls
- Sterilization methods
- Sterility Assurance Level (SAL)
- Sterilization as a validated process
Part J – Material Controls
- Handling and Storage of Material
Part K – Records, Documents, and Change Controls
- Device Master Record
- Device History Record
- Quality System Record
- The records FDA Investigators should not examine
Part L – Statistical Techniques
- Determining and documenting statistical techniques
- Special considerations for sampling plans
Part M – Part 11 Electronic Records
- The role of Part 11
- Practical issues from the guidance document
Part N – Corrections and Removals
- What they are
- When to report
- When to keep records, but not report
Part O – Medical Device Reporting
- Linkage to complaints
- MDR Event files
- Report types
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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Boston, MA(Venue to be announced shortly)
June 16-17, 2016
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