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FDA Inspections: From SOP to 483 in (2021)
Date
Jun 29, 2021 - 10:00 AM
Link to Website
Organizer
Netzealous LLC DBA - Compliance4All
Venue
online
Location
161 Mission Falls Lane, Suite 216,,
Fremont,
California,
USA,
ZIP: 94539
Phone: 8004479407
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]
https://www.compliance4all.com/control/w_product/~product_id=502547LIVE?channel=nyeventslist_Jun_2021_SEO
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]
https://www.compliance4all.com/control/w_product/~product_id=502547LIVE?channel=nyeventslist_Jun_2021_SEO
Event Categories
NEWS CONFERENCES
, HEALTH AND MEDICINE CONFERENCES
, Healthcare
, Life Sciences, Biotechnology
, Technology
Keywords: Educational, HealthCare , FD