TEST COURSE
THE ESSENTIALS OF FDA SUBMISSION TESTING
WHO IS IT FOR?
This course is aimed at a diverse audience in the MedTech sector ranging from professionals directly involved in medical software testing to those who need to be aware of the testing requirements for successful FDA submissions.
COURSE DETAILS
Duration:
1 full-time day per week for 2 weeks.
Class size:
Max 5 students.
Delivery Method:
Face to face at the Hatchd and Adapptor studio, Perth CBD.
Prerequisites:
This is an entry level course. No prior experience is required.
What you’ll need:
All hardware resources supplied on premises.
LEARN FROM THE BEST
JACQUI BAGSHAW
QA MANAGER
SENIOR APP TESTER
DEB DOWSON
YOUR
LEARNING JOURNEY
MODULE 1
OVERVIEW OF THE FDA PROCESS
Understanding the importance of testing in FDA submissions and the difference between regions.
MODULE 2
UNDERSTANDING FDA REGULATIONS
Develop a solid knowledge of traceability.
MODULE 3
PREPARING FOR FDA SUBMISSION TESTING
Understanding verification and validation, developing a test SOP, a software test plan, a software test protocol and a software testing report
MODULE 4
HUMAN FACTOR AND USABILITY TESTING
Establishing formative and summative testing.
MODULE 5
RISK MANAGEMENT AND TESTING
How to incorporate risk management principles into testing.
MODULE 6
POST SUBMISSION CONSIDERATIONS
Understanding residual anomalies and the re-submission process.
PRICING
Total course price per person for 2 full days, includes lunch and all hardware is provided. Max class size of 5 people. Discounts apply when multiple places are booked.
1 person - $9,000 p/p ex GST
2 people - $8,100 p/p ex GST
3 people - $7,200 p/p ex GST
4 people - $6,300 p/p ex GST
5 people - $5,400 p/p ex GST
READY TO BOOK?
Unsure what you need? Don’t worry, we are not cookie cutter. Have a chat with us and we’ll customize your training and coaching program based on your team’s needs and budget.