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.
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.
Managers/Directors/Supervisors and Personnel related to:
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.
Managers/Directors/Supervisors and Personnel related to:
Jeff Kasoff
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 …
Understanding the Artificial Intelligence Landscape
Holiday Stress and Loss: The Art of Stress Resilience in E…
Establishing Appropriate Quality Metrics and Key Performanc…
Is Your Culture Working For or Against Your Success? If You…
Ultimate Persuasion Strategies! - Secret Influence Tools & …
Using High-Performance Coaching for Managers to Address Per…
Excel - 10 Key Worksheet Functions to Skyrocket Your Produc…
OSHA Requirements for Supervisors, Project Leaders & HR - W…
Transform Data into Insights: A Beginners Guide to Excel Pi…
Utilizing HR Metrics to Illustrate & Improve Human Resource…
Red flags that can render your OSHA Safety Program Complete…
The Human Element of Leadership in the Hybrid Work Experien…
How to Navigate Political Speech in the Workplace
What If Analysis Tools in Excel: Goal Seek, Solver, and Dat…
Project Management for administrative professionals
3-Hour Virtual Seminar on Chat GPT for Project Management i…
Mastering Year-End Payroll and Tax Compliance for 2024
How to Prepare For and Host a FDA Inspection and Respond to…
Eliminate Harmful And Unproductive Drama In The Workplace
Excel - Pivot Tables - The Key To Modern Data Analysis and …
5 Key Components of Good Manufacturing Practices to obtain …
FDA Technology Modernization Action Plan (TMAP) and Impact …
Team Synergy: How to Harness Collective Intelligence to Max…
The Anti-Kickback Statute: Enforcement and Recent Updates
Successful Strategies for FDA Expedited Pathways for Your D…
The Power Of Trust In The Workplace- Improving Your Career …
Managing Toxic & Other Employees Who Have Attitude Issues
Protect Your Company With The End of the Year HR Checklist
Do's and Don'ts of Giving Effective Feedback for Performanc…
So, You’re Now the “Boss”: Essential Skills to Succeed as a…
Onboarding is NOT Orientation - How to Improve the New Empl…
Construction Lending And Real Credit Administration: Evalua…
Building GMP Excellence: A Guide to Implementing Compliant …
Improving Employee Engagement & Retention Through Stay Inte…
Understanding cognitive load in medical device design
Human Error Reduction Techniques for Floor Supervisors
Excel Power Skills: Master Functions, Formulas, and Macros …
