The Cutting Edge of Medical Technology Content, Community & Collaboration
Time: July 28, 2015 from 1pm to 2pm
Street: 5939 Candlebrook Ct
Website or Map: https://compliancetrainings.c…
Event Type: webinar
Organized By: Compliance Trainings
Latest Activity: Jun 26, 2015
This webinar is intended to provide guidance on understanding, interpreting, and implementing design control procedures in a way to survive an FDA inspection. This presentation is further intended to help you establish and maintain adequate design control procedures for all classes of medical devices including IVDs. In particular, this webinar will address how to best prepare for an FDA inspection concerning design control using real case examples.
Understanding, interpreting, and implementing design control system requirements in a holistic manner can significantly contribute to your product quality and regulatory compliance, helping to ensure your innovative medical products to be safe and effective on a global market and saving enormous amount of your unnecessary time, efforts and investment.
This 60-min presentation will provide great opportunities to get familiar with design control requirements and the FDA inspection concerning design control systems applicable to all types of medical devices including IVDs.
This webinar is a must for medical device and IVD firms including anyone interested in the topics from other industry.
Areas Covered in the Session :
Applicable Laws and Regulations
Design Control Requirements
Design and Development Planning
Design Input and Design Output
Design Verification And Validation
Design Transfer and Design Changes
Design History File (DHF), Device History Record (DHR) and Device Master Record (DMR)
FDA Inspection for Design Control
Common Mistakes and How to Avoid
How to Prepare for FDA inspection for Design Control
Best Practices for Establishing and Maintaining a Design Control System
Speaker’s Recommendation and Suggestions on PASS-IT Solutions
Who Will Benefit:
Managers (RA, QA/QC, CA)
Contractors and Subcontractors
Anyone interested in the topic
For more information and enquiries contact us at
5939 Candlebrook Ct, Mississauga, ON L5V 2V5, Canada
Customer Support : #416-915-4458
Email : firstname.lastname@example.org