Make Your FDA Inspection as Painless as Possible
Angela Bazigos is the CEO of Touchstone Technologies Inc.
Seasoned Executive with 40 years of experience in the Life Sciences & Healthcare Industries. Positions include Chief Compliance Officer, IT Director & QA Director. Experience combines Quality Assurance, Regulatory Compliance, Business Administration, Information Technology, Project Management, Clinical Lab Science, Food / Public Health Service, and Turnarounds. Past employers / clients include Roche, Novartis, Genentech & PriceWaterhouseCoopers. Co-authored & prototyped 21 CFR 11 guidance with FDA and work with FDA on Data Integrity Regulations. Co-authored Computerized Systems in Clinical Research w/ FDA. Patent on speeding up software compliance https://www.google.com/patents/US8266578. Recently quoted in the 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 the FDA on new guidance documents. Former President of Pacific Regional Chapter of Society of Quality Assurance. Stanford’s Who’s Who for LifeSciences.
This is a detailed course designed to provide medical device/pharmaceutical professionals with the information they need to prepare for and manage any type of FDA inspection. This course provides the rationale, strategies, and flows on how to plan for an inspection, the inspection process and approach, and which company roles should be assigned for these types of inspections, among other related topics.
- Types of Inspections
- Dedicated personnel for inspection
- Facility resources to support the inspection
- Internal audits
- SOP for inspections
- Behavior during inspection: What to say and do, and what NOT to say and do
- Inspection process
- How and when to craft a written response
Course Level - Basic / Intermediate
Who Should Attend
This webinar will provide valuable assistance to all regulated companies since the 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
- Risk Management
- Complaint Handling
- Personnel new to the regulated industry
- Training personnel
- Document Control Personnel
Why Should Attend
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!
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.