Don’t let a common misunderstanding get you into trouble! There is more to the US Medical Device Regulations than Part 820.Learn the Law, Regulations, and Policies That FDA Applies for Medical Device
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
Course Content
DAY 01 (10:00 AM - 5:00 PM EDT)- 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
Course Provider
Stephanie Harrell,
Consultant ,
ProPharma GroupStephanie 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.
Who Should Attend
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
