FDA Inspections: From SOP to 483

Angela Bazigos
Instructor:
Angela Bazigos
Date:
Friday, June 28, 2019
Time:
10:00 AM PDT | 01:00 PM EDT
Duration:
90 Minutes

More Trainings by this Expert   Product Id : 502547

Price Details
$150 Live
$290 Corporate Live
$190 Recorded
$390 Corporate Recorded
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Live + Recorded
$289 $340 Live + Recorded
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$599 $680 Corporate
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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?

The FDA inspection is the most nerve-wracking event in the life of a regulatory professional - you're in charge of compliance, usually in the background, and NOW you're in the spotlight, and if your performance isn't good, it's not the show that may close, it's YOUR COMPANY! However, adequate planning, training, composure, and understanding should result in many encore presentations!

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.

Also contained in this session will be the limits of FDA's scope during an inspection, including what documents you are not required to show them, and the permissibility of photographs and affidavits.

Without adequate preparation and cross-functional communication, it is difficult to manage a good FDA inspection. Your goal is to illustrate your firm is in substantial compliance with all regulations, but also to respond to the inspector's questions or concerns in a timely manner. This webinar will identify systems and processes, and recommended tactics, to make the inspection as painless as possible

Areas Covered in the Session:

  • Types of Inspections
  • Preparation
    • Dedicated personnel for inspection
    • Facility resources to support the inspection
    • Internal audits
  • 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: This webinar will provide valuable assistance to all regulated companies, since FDA inspects across the Medical Device, Diagnostic, Pharmaceutical, and Biologics fields. The employees who will benefit include:
  • Quality Auditors
  • Compliance Officers
  • Executive Management
  • Managers/Directors/Supervisors and Personnel related to:
    • Regulatory Compliance and Regulatory Affairs
    • Quality Management System
    • Quality Assurance
    • Quality Control
    • Product Development
    • Engineering
    • Manufacturing
    • Risk Management
  • Complaint Handling
  • Personnel new to the regulated industry
  • Training Personnel
  • Document Control 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.

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. Positions include Chief Compliance Officer,Director of QA and MIS Director. Co-authored & prototyped 21 CFR 11 guidance with FDA. Co-authored Computerized Systems in Clinical Research w/ FDA & DIA 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 includes training 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.




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