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

Danielle DeLucy
Jan 7, 2020 - 10:00 AM EDT
Starting at

$599

Premier price: $539 (save 10%)

Single registration

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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.

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.

Learning 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

Areas Covered in the Webinar:

  • 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

Who Will Benefit:

  • Quality Assurance Staff
  • Quality Control Staff
  • Engineers
  • IT Staff
  • Manufacturing Supervisors and Managers
  • Documentation Staff
  • Directors, Managers, Supervisors
Webinar Events
Attend Live Webinar
Jan 7, 2020 - 10:00 AM EDT

Duration: 4 Hours

Single Attendee

Premier price: $539 (save 10%)

Group of 3 to 5

Premier price: $ 719 (save 10%)

Group of 6 to 10 + DVD USB

Premier price: $ 899 (save 10%)

Training CD-DVD

Physical CD-DVD of recorded session will be despatched after 72 hrs on completion of payment

Premier price: $ 1349 (save 10%)

Recorded video

Recorded video session

Premier price: $ 989 (save 10%)


Speaker: Danielle DeLucy, Pharmaceuticals, Biotechnology

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 has held positions in the Quality management arena while increasing her responsibility. She has helped to lead many Regulatory Health Inspections and was instrumental in the coaching process of her peers prior to any inspection. Currently, Danielle assists companies who are faced with warning letters, consent decrees and those wishing to improve compliance establish more robust quality systems so that the company can succeed.




Get in touch

646 905 0515

Fax

212-751-3500