An intensive one-day training course on how to establish and improve compliance with the GMP regulations for medical device design and development.
Background
The FDA Quality System Regulation, 21 CFR Part 820, and ISO 13485 both contain significant requirements in relation to Design Control.
In many cases manufacturers have not satisfactorily established full compliance with these regulations and have received adverse inspections, including issuance of FDA Form 483’s, Warning Letters and Import Alerts.
Learning Objectives
The course provides an opportunity to:
- Obtain the most up-to-date information in relation to design and development control requirements as defined in the FDA Quality System Regulation and ISO 13485.
- Understand FDA expectations for management of design control as detailed in their guidance for medical device manufacturers, and differences between the QS Regulation and ISO 13485.
- Understand how FDA use QSIT to determine compliance with the regulation during facility inspections.
- Understand use of risk management in the design control process.
- Improve confidence in preparing for, and hosting of an FDA inspection.
- Gain fresh quality improvement strategies for your company.
Course Format
The course presents the design control requirements comprehensively and uses interactive sessions as well as formal presentations. Each delegate is provided with a course manual containing comprehensive notes on topics presented, and copies of relevant regulations and guidance documents are provided for the use of delegates during the course.
Delegates receive a "Certificate of Attendance”.