2014 - Webinar on Quality System Regulations (QSRs) for Medical Devices and IVDs

FDA states in warning letters “This inspection revealed that these devices are adulterated within the meaning of section 510(h) of the FD&C Act, in that the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation are not in conformity with the current good manufacturing practice requirements of the 21 CFR Part 820…”. This webinar will address the said current good manufacturing practice (cGMP) requirements to help you stay in conformity with 21 CFR Part 820 (QSR).
Accurate understanding and interpretation of cGMP requirements found at 21 CFR Part 820 can significantly contribute to achieving compliance fast, resulting in saving significant amount of time and efforts and bringing innovative medical products to the market faster.
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
$ 249
Corporate Live : For Max. 10 Participants
$ 899
Recording
Single REC : For One Participant - Unlimited Access for 6 Months
$ 299
For enquiries and more contact us
Compliance Trainings
5939 Candlebrook Ct,
Mississauga, ON L5V 2V6,
Canada
Customer Support : #416-915-4458
Email : support-AT-compliancetrainings.com