Compliance Trainings, Online
2015-08-13
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 Definitions Design Control Requirements Design and Development Planning Design Input and Design Output Design Review 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: R&D Quality Regulatory Affairs Compliance Officers CEOs VPs Attorneys Complainant Managers Managers (RA, QA/QC, CA) Consultants Contractors and Subcontractors Anyone interested in the topic
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