Medical Device GMP Design Control Training Course
Course Category: Medical Devices
Course Title: Medical Device GMP Design Control Training Course
An intensive one-day training course on how to establish and improve compliance with the GMP regulations for medical device design and development.The FDA Quality System Regulation, 21 CFR Part 820, and ISO 13485:2003 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.
Course Presenter
This course is presented with our training partner, Tom Donnelly of Medicom Consulting.
Who should attend?
- Quality Managers
- Quality Control Professionals
- Healthcare Consultants
- Medical Device Consultants
- Enforcement Officers
- Regulatory Personnel
- Certification Bodies/Registrars
- Professionals in the Medical Device Industry & Supply Chain
Learning Objectives
- 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 13485:2003.
- Understand FDA expectations for management of design control as detailed in their guidance for medical device manufacturers.
- 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 Structure
This course is a 8 hour/1 day course.
Course Start: 09:00a.m & Course Finish: 17:00p.m
A detailed course breakdown is as follows:
- User requirements
- Design inputs
- Design outputs
- Design verification
- Design validation
- Design review
- Design transfer
- Design change control
- Design history file (DHF)
- Application of risk management to medical devices
- Inspection of design control by FDA under the QSIT
- Q & A
Training Methodology
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. This course can also be tailored to meet your specific requirements.
What's Included on the course
- Comprehensive Course Manual
- Delivery by Expert (s) with real life experience
- Additional Handouts
- Training Certificate of Attendance
Further Information
Kelmac Group offer all of our Training Solutions on an In Company/In House basis. These solutions can be tailored to meet the specific needs and requirements of the client.
Our fees are very competitive and if you would like further information, please contact our office directly on +353 (61) 4491224 or email info@kelmacgroup.com
€1,095*/Person-
21 May 2012
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11 June 2012
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13 June 2012
