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

Join us for a webinar on August 18 for a discussion of the webinar

Agenda:

Session 1:

Guidelines for Detecting an OOS or Atypical Result

  • Definition Atypical or Out of Specification Result?
  • Review of the FDA Guidance for Industry on Investigating OOS Test Results
  • Phase I: Initial Laboratory Investigation
  • Phase II: Full Scale Investigation

Root Cause Analysis Methods

  • 5 Whys
  • Flow Charts
  • Checklists
  • Fishbone Diagrams

 Session 2:

Testing the hypotheses regarding potential root causes

  • Retesting
  • Considering Other Batches

 Session 3:

Developing a proper CAPA plan to address any Corrective Actions

  • How to properly document findings
  • Example of a proper OOS investigation write up


This webinar will review the regulatory requirements for investigating an OOS Investigation. The responsibilities of the analyst, the supervisor and QA will be discussed. A detailed flow chart will be used to help the attendees clearly understand the steps and the order in which they are to be performed. The structure of an Investigation report which properly documents the investigation will be discussed.

Why Should You Attend

The lack of or Inadequate procedures for handling out of specification (OOS) situations and failure investigations are amongst the most frequently found deviations in FDA warning letters.

Most companies have procedures but either they are not adequate or are not followed. This seminar will guide attendees through the entire process from detection an out-of-specification result to informal and formal laboratory and batch investigations.

Who Will Benefit

  • QA managers and personnel
  • Analysts and lab managers
  • CAPA management
  • Regulatory affairs
  • Training departments

Industries who can attend

This 3 Hours Webinar -minute online course is intended for professionals in the Medical Device, Biotechnology,Pharmaceutical Industry. Although not presently stated in the draft , the same guide could be used by FDA Regulated Industries personnel.

Faculty Danielle DeLucy

Faculty 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.

Choose a Pricing Option

$398

Recorded Access Single User-6 month Access

You'll have access to one log-in for an archived recording of the entire 180-minute webinar, including the Q&A period, for 1 participant. 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

$698

MP3 Download (DVD)

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