2018 How the FDA are Trained for Medical Device Inspections

Overview:

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.

Why should you Attend: 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 inspectors' mind to understand what they are looking for during an inspection.

Who Will Benefit:

• Quality Managers
• Quality Engineers
• Regulatory Affairs
• Small Business Owners
• GxP
• Consultants
• Quality VPs
• IT VPs
• FDA Investigators
• Other Regulatory Agency Investigators

Speaker Profile
Angela Bazigos is the CEO of Touchstone Technologies Inc. She has degrees in Microbiology and Computing and 40 years of experience in the Life Sciences, Healthcare & Public Health Services. Experience combines Quality Assurance, Regulatory Compliance, Business Administration, Information Technology, Project Management, Clinical Lab Science, Microbiology, Food Safety & Turnarounds. Past employers / clients include Royal Berkshire Hospital, Roche, Novartis, Genentech, PriceWaterhouseCoopers & Stanford Hospital.