This is a detailed course designed to provide medical device/pharmaceutical professionals with the information they require to prepare for and manage FDA inspections. 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 to these types of inspections, among other related topics.
WHY SHOULD YOU 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! 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.
LEARNING OBJECTIVES
- Types of Inspections
- Preparation
- Dedicated personnel for inspection
- Facility resources to support the inspection
- Internal and/or mock audits: One, or Both?
- Contents of SOP for FDA Inspection
- Recommended behavior during inspection: What to say, what not to say, and how to say it
- Inspection process
- Best practices for response to the 483
- 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?
WHO WILL BENEFIT?
- Quality Auditors
- Compliance Officers
- Executive Management
- Training Personnel
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
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.
- Types of Inspections
- Preparation
- Dedicated personnel for inspection
- Facility resources to support the inspection
- Internal and/or mock audits: One, or Both?
- Contents of SOP for FDA Inspection
- Recommended behavior during inspection: What to say, what not to say, and how to say it
- Inspection process
- Best practices for response to the 483
- 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?
- Quality Auditors
- Compliance Officers
- Executive Management
- Training Personnel
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
Speaker Profile
![ins_img](/Speaker_Pics/jeff_kasoff.jpg)
Jeff Kasoff, RAC, CMQ/OE, LBB, is the Principal at Lean to Quality, LLC. He has more than 30 years in Quality and Regulatory management. Over that time, Jeff has implemented and overseen quality system operations and assured compliance, at all sizes of company, from startup to more than $100 million in revenue. This multi-faceted experience makes Jeff uniquely qualified to address compliance issues across the entire range of company sizes. Jeff has also been primary liaison with FDA inspectors and notified body auditors, giving him first-hand experience with the most common issues surfaced by regulatory agencies. Jeff has the following …
Upcoming Webinars
![](/static/images/default-webinar-info.jpg)
Performance of Root Cause Analysis, CAPA, and Effectiveness…
![](/static/images/default-webinar-info.jpg)
Stress, Change And Team Resilience Through Humor: An Intera…
![](https://247compliance.com/Speaker_Pics/planing.jpg )
![](https://247compliance.com/Speaker_Pics/hiring.jpg)
Future-Forward Onboarding: Navigating Success in 2024 for M…
![](https://247compliance.com/static/images/hr.webp)
Utilizing HR Metrics to Illustrate & Improve Human Resource…
![](/static/images/default-webinar-info.jpg)
Basics of Investigational Drug Services
![](/static/images/default-webinar-info.jpg)
Data Integrity and Privacy: Compliance with 21 CFR Part 11,…
![](/static/images/default-webinar-info.jpg)
Excel - Pivot Tables - The Key To Modern Data Analysis and …
![](/static/images/default-webinar-info.jpg)
Employee Business Expense Reimbursement (2024 Updates)
![](https://247compliance.com/static/images/72.jpg)
Stay Interviews: A Powerful Engagement and Retention Tool
![](/static/images/default-webinar-info.jpg)
The Magic of Engagement: The Profitability of An Engaged Wo…
![](/static/images/default-webinar-info.jpg)
![](/static/images/default-webinar-info.jpg)
Risk Management in the FedNow® Instant Payments Era
![](/static/images/default-webinar-info.jpg)
Marketing to Medicare or Medicaid Beneficiaries - What You …
![](https://247compliance.com/Speaker_Pics/oo.jpg)
FFIEC BSA/AML Examination Manual: What Compliance Officers …
![](/static/images/default-webinar-info.jpg)
![](/static/images/default-webinar-info.jpg)
Gossip-Free: Leadership Techniques to Quell Office Chatter
![](/static/images/default-webinar-info.jpg)
2-Hour Virtual Seminar on The Complexity and Interplay Amon…
![](/static/images/default-webinar-info.jpg)
How to Prepare For and Host a FDA Inspection and Respond to…
![](/static/images/default-webinar-info.jpg)
Pay Transparency: The Why and How for HR Pros
![](/static/images/default-webinar-info.jpg)
FDA Compliance And Laboratory Computer System Validation
![](/static/images/default-webinar-info.jpg)
Stark After Tuomey, Intermountain Health, Akron General, Pr…
![](/static/images/default-webinar-info.jpg)
Project Management for Non-Project Managers - Scheduling yo…
![](/static/images/default-webinar-info.jpg)
Your Workplace Culture for 2024: If You Don't Get It Right,…
![](/static/images/default-webinar-info.jpg)
Tech Etiquette for Customer Service Help Desk Professionals
![](https://247compliance.com/static/images/organized-work.jpg)
![](/static/images/default-webinar-info.jpg)
Implementing an Effective Succession Plan to Identify, Deve…
![](/static/images/default-webinar-info.jpg)
Impact of machine learning in pre-clinical research and reg…
![](/static/images/default-webinar-info.jpg)
4-Hour Virtual Seminar on Transformational Leadership - The…
![](https://247compliance.com/static/images/73.jpg)
Project Management for administrative professionals
![](https://247compliance.com/static/images/excel-data.jpg)
3-Hour Excel Automation Boot Camp: Top Ten Excel Functions …
![](/static/images/default-webinar-info.jpg)
Work Well Remotely: Healthy Habits at Home
![](https://247compliance.com/Speaker_Pics/csd.jpg)
IRS Form 1099 Reporting: Compliance Requirements
![](/static/images/default-webinar-info.jpg)
Understanding Emerging Payments Fraud and Risk Management
![](https://247compliance.com/Speaker_Pics/laboratory-3827743_960_720.jpg)
![](https://247compliance.com/static/images/pharma-trend.jpg)
Sunshine Act Reporting - Clarification for Clinical Research
![](/static/images/default-webinar-info.jpg)
Navigating FDA Inspections: From SOP to 483
![](https://247compliance.com/static/images/fatal-errors.jpg)
Implementing an Effective Human Error Reduction Program
![](/static/images/default-webinar-info.jpg)
Fair Debt Collection Practices Act (FDCPA)
![](/static/images/default-webinar-info.jpg)
![](/static/images/default-webinar-info.jpg)
Complying with the NEW I-9 and E-Verify Regulations - The I…
![](/static/images/default-webinar-info.jpg)
SOPs - How to Write Them to Satisfy those Inspectors
![](https://247compliance.com/Speaker_Pics/student-849821__340.jpg)
![](https://247compliance.com/static/images/sick.jpg)
Stressed Out: How to Handle Conflict, Difficult People and …
![](https://247compliance.com/Speaker_Pics/food-2373415_960_720.jpg)
California Meal and Rest Breaks: What You Dont Know Can Cos…
![](https://247compliance.com/Speaker_Pics/ver.jpg )
Harassment, Bullying, Gossip, Confrontational and Disruptiv…
![](https://247compliance.com/Speaker_Pics/currency-3118767_960_720.jpg)
Why EBITDA Doesn't Spell Cash Flow and What Does
![](https://247compliance.com/static/images/hr-employee.jpg)
Using Behavior Based Interviewing for Finding the Best Matc…
![](/static/images/default-webinar-info.jpg)
Onboarding is Not Orientation: How to Improve Your New Hire…
![](https://247compliance.com/static/images/travel-expenses.webp)
Dealing With Difficult People In Life & Work