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.
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
|1||2 Attendees||10% off|
|2||3 to 6 Attendees||20% off|
|3||7 to 10 Attendees||25% off|
|4||10+ Attendees||30% off|
To avail the above group discounts, all the participants should register by making a single payment
Call our representative TODAY on 1800 447 9407 to have your seats confirmed!
Seasoned Executive with 40 years of experience in the Life Sciences & Healthcare Industries. Positions include Chief Compliance Officer http://morflearning.com/angelabazigos/. Experience combines Quality Assurance, Regulatory Compliance, Business Administration, Information Technology, Project Management, Clinical Lab Science, Turnarounds and Business Development. Past employers / clients include Roche, Novartis, Genentech & PriceWaterhouseCoopers. Co-authored & prototyped 21 CFR 11 guidance with FDA. Co-authored Computerized Systems in Clinical Research w/ FDA http://www1.diahome.org/~/media/4FA562336EBD46C58CDC43A8B7773095.ashx Patent on speeding up software compliance https://www.google.com/patents/US8266578. Recently quoted in Wall Street Journal for using training to bring regulatory compliance to the Boardroom http://blogs.wsj.com/riskandcompliance/2015/07/24/using-training-to-bring-compliance-to-boardrooms/ 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 LifeSciences: http://www.stanfordwhoswho.com/Angela.Bazigos.7144112.html#overview.