Overview
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.
Why Should Attend
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!
Webinar Takeaway
- Types of inspections
- Preparation
- 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?
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
- Product Development
- Engineering
- Manufacturing
- Complaint Handling
- Personnel new to the regulated industry
- Training personnel
- Document Control Personnel
José Mora
Principal Consultant, Atzari Consulting, LLC
Jose Mora is a Principal Consultant specializing in Manufacturing Engineering and Quality Systems. For over 30 years he has worked in the medical device industry specializing in manufacturing, process development, tooling, and quality systems. Prior to working full time as a consulting partner for Atzari Consulting, José served as Director of Manufacturing Engineering at Boston Scientific and as Quality Systems Manager at Stryker Orthopedics, where he introduced process performance, problem solving, and quality system methodologies. During that time, he prepared a white paper on the application of lean manufacturing methods to the creation and management of controlled documents and a template for strategic deployment.
1.0 RAC CREDITS
RAPS - This course has been pre-approved by RAPS as eligible for up to 1.0 credits towards a participant's RAC recertification upon full completion.
World Compliance Seminars (WCS) is a Regulatory Affairs Professional Society (RAPS) RA Professional Development Portal provider. World Compliance Seminars is committed to enhancing the ongoing professional development of regulatory affairs professionals and other stakeholders through appropriate regulatory affairs learning activities and programs. World Compliance Seminars has agreed to follow RAPS-established operational and educational criteria
