Companies can prepare and train their staffs effectively for prior inspection management, but once the audit begins, certain difficult situations, requests or issues may arise that may prove hard to manage properly. In this webinar, you will hear about real life examples of inspection issues on different topics such as Opening Day, Documentation, Tours, SME situations, Safety, and Inspection team situations. We will examine what went right and how the situation may have been handled differently.
WHY SHOULD YOU ATTEND?
Every year or so, companies are visited by the FDA and other regulators to determine if they are properly complying with regulations.Once the inspectors arrive, there may be times that situations arise that are difficult to respond to. In this webinar, we will analyze how certain situations were handled and how they could have been handled differently, or what was positive about how they were handled.
LEARNING OBJECTIVES
- What to expect during an FDA inspection
- The opening meeting, daily close out and final meeting
- Real-life scenarios and how to properly respond
- Tips for a successful audit
- How to handle difficult questioning, how to properly interact with the inspectors during the course of the audit
- Organizing the inspection rooms, teams and conducting the proper pre-audit training
- Real life scenarios will be examined, how they were handled and what the result was
WHO WILL BENEFIT?
- Site Quality Operations Managers
- Quality Assurance personnel
- Plant Managers and Supervisors
- Manufacturing Superintendents and Managers
- Individuals whose job knowledge and/or expertise may be called upon during an audit
- Regulatory Affairs Managers
Every year or so, companies are visited by the FDA and other regulators to determine if they are properly complying with regulations.Once the inspectors arrive, there may be times that situations arise that are difficult to respond to. In this webinar, we will analyze how certain situations were handled and how they could have been handled differently, or what was positive about how they were handled.
- What to expect during an FDA inspection
- The opening meeting, daily close out and final meeting
- Real-life scenarios and how to properly respond
- Tips for a successful audit
- How to handle difficult questioning, how to properly interact with the inspectors during the course of the audit
- Organizing the inspection rooms, teams and conducting the proper pre-audit training
- Real life scenarios will be examined, how they were handled and what the result was
- Site Quality Operations Managers
- Quality Assurance personnel
- Plant Managers and Supervisors
- Manufacturing Superintendents and Managers
- Individuals whose job knowledge and/or expertise may be called upon during an audit
- Regulatory Affairs Managers
Speaker Profile

Danielle DeLucy, MS, is owner of ASA Training and Consulting, LLC which provides Pharmaceutical and Biologics based companies with training and quality systems assistance in order to meet Regulatory compliance. Prior to this role, Danielle has been in the industry for 15 years serving in numerous Quality Management Roles, such as the Director of Product Quality, the oversight of Sterility Assurance practices and provided QA oversight of numerous filling and packaging operations. Danielle began her QA career as a Quality Control Pharmaceutical Microbiologist at a contract laboratory where she performed various tests for their clients. In the years after, she …
Upcoming Webinars

Better Business Writing - How to Write Right

FLSA 2022 White Collar Exemptions and Minimum Wages Require…

Emotional Intelligence: Mastering the Emotions of Great Lea…

Managing Toxic & Other Employees Who Have Attitude Issues



Payments Fraud Detect & Prevent Check, ACH and P-Card Schem…

An EEOC Audit May Be Coming Soon! Are You Prepared?

Retaining Employees During the Great Resignation

Stay Interviews: A Powerful Engagement and Retention Tool

How to Write Procedures to Avoid Human Errors

Crucial Compensation Conversations - Understanding and Comm…

2022 EEOC and Employers: Investigating Harassment and Discr…



Understanding and Analyzing Financial Statements


Neutralizing Harassment - How to Promote the Proactive Pers…

Ultimate Time Management - Take Complete Control of Your Ti…

Creating Your Ultimate Competitive Advantage - As A Stress …

GMP Environmental Monitoring for Pharmaceutical Clean Rooms

New W9 vs 1099: IRS Forms, Differences, and When to Use The…


Using Stay Interviews To Improve Employee Retention & Engag…

Employee Handbook 2022 Update. Includes Updated Federal, St…