Purchase any WEBINAR and get
10% Off
CODE: SAVE10
T&C applicable, please referFAQ
Validity : 18th Apr'24 to 28th Apr'24
How the FDA are Trained for Medical Device Inspections
Session 1
Duration: 1 hour
Quality System Inspection Technique (QSIT)
- The Quality System (QS) Regulation
- The MDR Regulation
- The Medical Device Tracking Regulation
- The Corrections and Removals Regulation
- The Registration and Listing Regulation
Session 2
Duration: 1 hour 15 minutes
Implementation
- Inspector’s Objectives
- Program Management Instructions
Inspectional Operations
Inspectional Strategy
- QS inspections
- Level 1 Inspections
- Level 2 Inspections
- Level 3 Inspections
- For Cause Inspections
- Risk Based Work Plan Inspections
-
Foreign Inspections
Inspectional Instructions
- Special Instructions Concerning Design Control
- Special Instructions Concerning Design Controls
- Special Instructions for Sterilization Processes
- Inspection of Radiation Emitting Devices
-
Sample Collection
Additional Considerations
- Registration and Listing
- Imports
- Exports
- Electronic Records and Electronic Signatures
- Re-marketed Devices
-
Reporting
Analytical
- Analyzing Laboratories
- Analyses to be Conducted
- Methodology
Session 3
Duration: 45 minutes
- Regulatory/Administrative Follow-up
- Quality System/GMP Regulatory/Administrative Follow-up
- Compliance Decision
- Contract Sterilizers, Contract Device Manufacturers and
- Finished Device Manufacturers – Deciding Responsibility
- When Taking Regulatory Action
- Violative Devices Sold to Government Agencies
- Administrative and Judicial Actions
- Facilitating Review of Regulatory Recommendations
- MDR Regulatory/Administrative Follow-up
- Tracking Regulatory/Administrative Follow-up
- Corrections and Removals Regulatory/Administrative Follow-up
- Registration and Listing Regulatory/Administrative Follow-up
- Radiation Emitting Device Regulatory/Administrative Follow-up
Overview of the webinar
FDA Field Inspectors conduct administrative and enforcement activities related to the Quality System (QS) Regulation (21 CFR 820), the Medical Device Reporting (MDR) Regulation (21 CFR 803), the Medical Device Tracking Regulation (21 CFR 821), the Corrections & Removals Regulation (21 CFR 806) and the Registration & Listing Regulation (21 CFR 807).
Under the QS regulation, manufacturers are expected to control their devices from design stage through post market surveillance. Manufacturing processes, such as sterilization, are required to be implemented under appropriate controls. The MDR, Tracking and Corrections and Removals regulations involve activities with which manufacturers and importers are required to comply after the devices are distributed. Before inspectors can conduct the above inspections, they are trained by the FDA on how to conduct inspections. This training program encompasses the five regulations for inspecting medical device firms.
Who should attend?
- Quality Managers
- Quality Engineers
- Regulatory Affairs
- Small business owners
- GxP
- Consultants
- Quality VPs
- IT VPs
- FDA investigators
- Other regulatory agency investigators
Why should you attend?
This webinar will examine the training that FDA inspectors receive on five regulations for inspecting medical device firms. It will present the specific guidance FDA inspectors receive for each of the regulations. As a result, attendees will understand not only what they need to do to set up their company for a successful inspection, but also why they need to do it. They will get insight into the workings of the inspector's mind to understand what they are looking for during an inspection.
Faculty - Mz.Angela Bazigos
Angela Bazigos, is the CEO of Touchstone Technologies, Inc. She has 40 years of experience working in hospitals and Pharma industry. Her background includes companies like Roche, Novartis, Genentech and PricewaterhouseCoopers in GLP, GCP, GMP, Medical Device and Data Integrity Roles. She has held positions such as Chief Compliance Officer, QA Director and has acted on behalf CEO for communications with FDA.
Ms. Bazigos is a Past President of PRCSQA, a member of the SQA CVIC, ASQ, DIA and RAPS. She works closely with the FDA on behalf of her clients. She consults to Life Science Investment Groups as well as to Pharma / Biotech / Medical Device companies on compliance matters, including strategy, submissions, quality assurance and remediation following action by the FDA. Has contributed to prototyping of 21 CFR 11 & CSV before promulgation to industry.
Ms. Bazigos co-authored Computerized Systems in Clinical Research / Current Data Quality and Data Integrity Concepts with FDA, DIA and Academia. She holds a patent in speeding up software validation. She has been on the board for UC Berkeley’s Business School for Executive Education in Life Sciences and is now on the Stanford Who’s Who Registry for contributions to the Life Sciences industry.