Webinar Includes : All the training handouts , certificate ,Q/A and 180 mins Live Webinar

Join us for a webinar on Febuary 11 for a discussion of the webinar .

Who Will Benefit

  • Site Quality Operations Managers
  • Quality Assurance personnel
  • Plant Managers and Supervisors
  • Manufacturing Superintendents and Managers
  • Regulatory Affairs Managers
  • QC Lab staff

Webinar Takeaway

  • Review of FDA and Regulatory Requirements for Investigations
  • What is the definition of a Deviation?
  • Types of Deviations/Identification of Deviations
  • Conducting the Investigation
  • Interviews – dos and don’ts
  • Source Documents/Evidence
  • Determining Root Cause and Effective/Sustainable CAPA to avoid 483 observations
  • Key Elements of the Investigation Report

Overview

Deviation investigations are a very common topic to be reviewed during FDA investigations. Ensuring the firm has robust and complete write-ups of these situations is key to a successful audit. Having inadequate investigations could potentially cause some severe issues for the company and may sometimes result in warning letters, consent decrees or recalls.

Objectives

  • Discuss what to do when problems occur
  • Outline the requirements of the Deviation and procedure including the deviation report
  • Choose the most appropriate Root Cause Analysis methods for the situation
  • Discuss how to conduct the deviation and the tools to be used in the process

Why Should You Attend

This webinar will help attendees understand the fundamental steps of a deviation investigation with focus on using facts and objective evidence to arrive at root cause and CAPA. This webinar will focus on how to avoid the pitfalls that may occur during FDA inspections and help eliminate 483 observations. Learn how to identify and avoid potential pitfalls during deviation investigations.

Faculty Danielle DeLucy

Danielle DeLucy

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.  

Choose a Pricing Option

$399

Live Webinar - Single Partcipant

You get one log-in for the live 180-minute webinar for one participant, presentation materials and the opportunity to ask questions by phone and email

$489

Group Up to 5 Participants ( MP3 Download Free )

You get 5 log-in for the live 180-minute webinar for all the participant, presentation materials , Recorded Access Download and the opportunity to ask questions by phone and email

$389

Recorded Access Corporate Group

You'll have Group access to one log-in for an archived recording of the entire 180-minute webinar, including the Q&A period, for 1 location. You can log in any time of day or night. You'll also receive all presentation materials, plus an audio recording and transcript for the entire session. Delivery is approximately 48 hours after the session

$499

MP3 Download - Training DVD

Within 48 hours delivered - Lifetime Access ,Audio recording of a webinar and reference manual delivered by download. Listen anytime on any compatible device.

$599

Live + Recorded Access - Single Participant

You get one log-in for the live & recorded 180-minute webinar for one participant, presentation materials and the opportunity to ask questions by phone and email