The US Food and Drug Administration (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 to be Covered:
FDA Quality System Regulations
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
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:
R&D and Manufacturing Managers
Managers (RA, QA/QC, CA)
Contractors and Subcontractors