FDA Inspections: From SOP to 483 in (2019)

Overview:
Does the FDA call in advance or just show up at my door? Where do I let the inspector go? Do I give them a tour? What should I let them see? Who should I let them talk to? Are they ever going to leave?

Why should you Attend:
This session will discuss how to prepare for the inspection, what to do during the inspection and the close-out interview, and how to respond to the inspection.

Areas Covered in the Session:
SOP for inspections
Behaviour during inspection: What to say and do, and what NOT to say and do
Inspection process
How and when to craft a written response

Who Will Benefit:
Quality Auditors
Compliance Officers
Executive Management
Complaint Handling
Personnel new to the regulated industry
Training Personnel

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.

Event Fee: One Dial-in One Attendee Price: $150.00

Contact Detail:
Compliance4All DBA NetZealous,
Phone: +1-800-447-9407
Email: [email protected]