The goal of the training is to provide learners new to the device industry an introduction to regulations and responsibilities of investigational device studies by the FDA. Learners will review the key requirements of 21 CFR Part 812, identify similarities and differences with 21 CFR Part 312, and compare developmental pathways of new drugs and new devices. The training will additionally walk through other important differences in day to day of device and drug studies, such as site assessment, investigator training, monitoring, documentation and the trial master file.
DAY ONE 8:00 am - 5:00 pm
DAY TWO: 8:00 am - 1:30 pm
Developing Risk-Based Strategies for Device Studies
Securing Compliance in Device Studies: Effective Monitoring and Site Management
Safety Monitoring and Oversight: DSMBs, CECs and Medical Monitors
Building Quality into Device Studies
FDA’s BIMO Program: Inspection of Sponsors, CROs, and Monitors – “Preparing for Inspection Success from Day 1”
TYPE
KNOWLEDGE LEVELS:
WHAT’S INCLUDED
Foundation Package:
The History of Clinical Research
Introduction to Good Clinical Practice
Introduction to U.S. FDA Regulations
Introduction to U.S. FDA Regulations Part I: 21 CFR Parts 312 and 812
Introduction to U.S. FDA Regulations Part II: 21 CFR Parts 50, 56, 54 and 11
Comparing 21 CFR Part 312 and 21 CFR Part 812
Human Subjects Protection
Human Subject Protection: Drilling Down 21 CFR Part 50
Introduction to HIPAA and HITECH
The FAIR ShakeTM Method
Key Roles and Responsibilities in Clinical Research
Project Manager Overview
Monitor Overview
Primary Investigator Overview
Research Coordinator Overview
One Day Agenda: 8:00 – 5:00pm
International Guidance for Medical Devices
ISO 14155: Overview of the Standard
21 CFR 812 vs. ISO 14155: Key Differences
Day to Day Best Practices
Adverse Event Classification and Reporting
Investigational Device Accountability
High Quality Documentation and Maintaining the
Sponsor TMF
Developing Risk-Based Strategies for Device Studies
Securing Compliance in Device Studies: Effective
Monitoring and Site Management
