Course "Hosting FDA Regulatory Inspections" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.
The course will go through what typically goes on during an FDA inspection and will then cover how to prepare for, host and follow up to a regulatory inspection. It will focus the things that you should do or not do during the inspection. Typically FDA inspections can be highly structured and there are usually procedures that are to be followed. It is important for anyone who might be involved in the inspection to be aware of these procedures.
The course will also provide information for inspections conducted by international agencies as well as non- FDA agencies, including self inspections for manufacturing. It will explain how to prepare for an inspection, how to handle a scheduled or non-scheduled inspection, what to expect during an inspection and what follow up to expect after an inspection.
Finally, the course will provide information on how to respond to issues that come up during inspections and what to do to ensure best outcome from the inspection.
Day 1 Schedule
Lecture 1: FDA Inspections: FDA Inspection Program Overview
Lecture 2: FDA Inspections: Key factors for a successful FDA inspection
Lecture 3: FDA Inspections: Quality System Readiness
Lecture 4: FDA Inspections: Information Readiness
Lecture 5: FDA Inspections: Organization Readiness
Lecture 6: FDA Inspections: Manage Inspection Outcomes
Day 2 Schedule
Lecture 1: FDA Inspections: Managing Regulatory Risk
Lecture 2: FDA Inspections: Food Facility Inspections
Lecture 3: FDA Inspections: Medical Device Inspections
Lecture 4: FDA Inspections: 21 CFR 11 Inspections
Lecture 5: FDA Inspections: FDA Quality Metrics
Lecture 6: FDA Inspections: CAPA
Lecture 7: FDA Inspections: Writing Effective SOPs
Ms Angela Bazigos,
Touchstone Technologies Silicon Valley
Angela Bazigos.CEO of Touchstone Technologies Inc. She has 40 years of experience in the Life Sciences & Healthcare Industries. Experience combines Quality Assurance, Regulatory Compliance, Business Administration, Information Technology, Project Management, Clinical Lab Science, Microbiology, Food Safety, Turnarounds and Business Development. Past employers / clients include Roche, Novartis, Genentech & PriceWaterhouseCoopers. Positions include Chief Compliance Officer at Morf Media. Co-authored & prototyped 21 CFR 11 guidance with FDA. Co-authored Computerized Systems in Clinical Research w/ FDA. Patent on speeding up software compliance. Recently quoted in Wall Street Journal for using training to bring regulatory compliance to the Boardroom. National Trainer for Society of Quality Assurance. Comments / collaborates with FDA on new guidance documents. Former President of Pacific Regional Chapter of Society of Quality Assurance. Stanford’s Who’s Who for Life Sciences.
San Diego, CA
Venue to be announced shortly.