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
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.
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.
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:
o Regulatory Compliance and Regulatory Affairs;
o Quality Management System;
o Quality Assurance;
o Product Development;
o Engineering;
o Manufacturing;
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.
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:
o Regulatory Compliance and Regulatory Affairs;
o Quality Management System;
o Quality Assurance;
o Product Development;
o Engineering;
o Manufacturing;
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 …
Female to Female Hostility @Workplace: All you Need to Know
The Importance of the first 5 seconds when presenting
How to Manage the Legal Landmine of the FMLA, ADA and Worke…
Managing Difficult Employee Conversations
How to Write Effective Audit Observations: The Principles f…
Managing Toxic & Other Employees Who Have Attitude Issues
2025 EEOC & Employers: Investigating Claims of Harassment …
Leadership: Strategic Planning and Decision Making
FDA Proposes Framework to Advance Credibility of AI Models
Reduce Stress in the Workplace: Effective Ways to Handle Co…
ChatGPT and Project Management: Leveraging AI for Project M…
Leverage AI-Powered Tools for Talent Acquisition: Best Prac…
6-Hour Virtual Seminar on Learning the Highlights of Excel …
With Mandatory Paid Leave Gaining Ground Is It Time To Do A…
Form W-9 Compliance: TIN Verification, B Notices, and Avoid…
How to Give Corrective Feedback: The CARE Model - Eliminati…
Tattoos, hijabs, piercings, and pink hair: The challenges …
Stress, Change And Team Resilience Through Humor: An Intera…
Elevate Your Workplace Wellness: 10 Critical Wellness Facto…
AML Regulatory Insight for Q1 2025: Implementing recent cha…
How to Write Right for Better Business Communication
Gossip-Free: Leadership Techniques to Quell Office Chatter
Improving Employee Engagement & Retention Through Stay Inte…
Transforming Anger And Conflict Into Collaborative Problem …