Bookmark Add to Calendar

4-Hour Virtual Training: How to Respond to an FDA Investigation

4389
07-September-2022 :01:00 PM EDT Duration : 4 Hours

Joy L. McElroy,

Upon earning a degree in Zoology at North Carolina State University, Joy began working in the pharmaceutical and biotech industries in 1992 at Pharmacia & UpJohn performing Environmental Monitoring and Sterility Testing.  Her work allowed her to move into a supervisory role at Abbott Labo Read more


This FDA investigation training program will deconstruct best practices for handling unannounced FDA visits, responding to a 483 or a warning letter, and the effect of an FDA investigation. The program will also discuss basic concepts that should be employed by everyone regulated by the FDA and define processes for preparing for FDA audits.

Course Objectives:

• What should a company do if the FDA shows up unannounced
• How should a company respond to 483 observations or a warning letter
• The effect an FDA investigation can have on a company
• The basic concepts that should be employed by everyone regulated by the FDA
• How a company can prepare for situations like this
• Lesson learned
• How a company can balance the need to prepare for a potential FDA investigation or enforcement action and still run a profitable business

Why Should You Attend:

This webinar will illustrate how to respond to an FDA investigation. It could be a 483 observation, a warning letter, or a consent decree, all of which will impact how you carry on your business while under investigation.

The course will deconstruct best practices for handling unannounced FDA visits, responding to a 483 or a warning letter, and the effect of an FDA investigation. The program will also discuss basic concepts that should be employed by everyone regulated by the FDA and define processes for preparing for FDA audits.

Course Outline:

• Unannounced FDA visits
• Responding to a 483 or a warning letter
• Effect of an FDA investigation
• Basic concepts that should be employed by everyone regulated by the FDA
• Preparing for FDA audits
• Lessons learned
• Balancing preparing for the FDA investigation or enforcement action and still running a profitable business

What You Get:

• Training Materials
• Live Q&A Session with our Expert
• Participation Certificate
• Access to Signup Community (Optional)
• Reward Points

Who Will Benefit:

• Quality Assurance Staff
• Quality Control Staff
• Engineers
• IT Staff
• Manufacturing Supervisors and Managers
• Documentation Staff
• Directors, Managers, Supervisors

Please reach us at 1-888-844-8963 for any further assistance or if you wish to register

Get In Touch

Subject : 4-Hour Virtual Training: How to Respond to an FDA Investigation


Similar Trainings

Good Clinical Practices Review of ICH E6
LIVE : Scheduled on 16-August-2022 :03:00 PM EDT
Good Documentation Practices
LIVE : Scheduled on 17-August-2022 :01:00 PM EDT
3-Hour Virtual Seminar on Handling OOS Test Results and Completing Robust Investigations
LIVE : Scheduled on 22-August-2022 :01:00 PM EDT
Microbial Control, Monitoring and Validation of Water Systems for Pharmaceuticals and Biologics
LIVE : Scheduled on 25-August-2022 :01:00 PM EDT
Technical Writing Best Practices
LIVE : Scheduled on 30-August-2022 :01:00 PM EDT
paypal payment Comodo

Copyright ©2022 Signup Training. All rights reserved.