2015 - Webinar On Current Good Manufacturing Practices (cGMP) for Medical Devices and IVDs

Description :
This webinar is intended to help you get familiar with FDA’s Quality System Regulations (cGMP) for medical devices including in vitro diagnostic medical devices. This webinar is further intended to provide guidance on the best practices for implementing 21 CFR Part 820 (QSRs), which helps assure that medical devices are safe and effective for their intended use.
This 60-min webinar will help you ensure if you engage in the best practices for establishing and maintaining quality management systems necessary to achieve compliance and to remain compliant with 21 CFR Part 820 (cGMPs).
Areas Covered in the Session :
Applicable Laws
FDA Quality System Regulations
Definitions
Design Control: Design And Development Planning, Design Input, Design Output, Design Review, Design Verification, Design Validation, Design Transfer, And Design Changes
Design History File (DHF)
Quality System Procedures, Purchasing Controls And Servicing
Inspection, Measuring And Test Equipment
Process Validation
Corrective And Preventive Action (CAPA) And Complaint Files
Quality Requirements For Premarket Approval (PMA) Application
Device History Record (DHR) And Device Master Record (DMR)
Mistakes While Implementing QSRs
How to Avoid Mistakes
Frequent Citations in 483s and How to Avoid
Top 20 Items Cited in 483s
Lessons Learned: Best Practices
Who Will Benefit:
CEOs
VPs
Compliance Officers
Attorneys
R&D and Manufacturing Managers
Managers (RA, QA/QC, CA)
Consultants
Contractors and Subcontractors
Price tags:
Live
Single Live : For One Participant
$ 189
Corporate Live : For Max. 10 Participants
$ 699
Recording
Single REC : For One Participant - Unlimited Access for 6 Months
$ 239
For more information and enquiries contact us at
Compliance Trainings
5939 Candlebrook Ct, Mississauga, ON L5V 2V5, Canada
Customer Support : #416-915-4458
Email : support-AT-compliancetrainings.com
For more information about this event please visit
https://compliancetrainings.com/SiteEngine/Product...
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