One-hour webinar from Compliance4All on Handling (OOS Test) Results and Completing Robust Investigations

2024-04-14 04:11:36 Education

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Fremont, CA: Handling OOS test results and completing robust investigations is the topic of a 60-minute webinar that Compliance4All, a leading provider of professional trainings for the areas of regulatory compliance, is organizing on July 9. Danielle DeLucy, owner of ASA Training and Consulting, LLC, will be the speaker at this webinar. To register for this webinar and know more; please visit http://bit.ly/2MEap0U

In the field of laboratory science, Out of Specification (OOS) is the term given to any laboratory or pharmaceutical result that deviates to some or another degree from what is considered acceptance criteria as stated and recognized in appropriate professional compendia or as required by company specifications.

Naturally, the regulatory agencies view OOS rather seriously, simply because of the grave implications this can have on the quality of the product, which can adversely affect the health of the population that is administered OOS drugs and other pharma products.
With the lack of or insufficient procedures for handling OOS situations and failure investigations figuring amongst the most frequently found deviations in FDA Warning Letters; it is imperative for companies to establish robust practices for reporting OOS. The ways of doing these is the core of this webinar. It may surprise many that most companies have procedures, but these are either not sufficient, or are not adhered to.

Understanding of the full process
Danielle, who has extensive experience in helping companies that are faced with Warning Letters and consent decrees, and in helping organizations that wish to improve compliance establish more robust Quality Systems; will guide the participants of this webinar through the entire process from detection an Out of Specification result, all the way up to informal and formal laboratory and batch investigations. She will explain the regulatory requirements for investigating an OOS Investigation.
Danielle will explain the responsibilities of the analyst, the supervisor and QA. She will illustrate a detailed flow chart, with the help of which, the attendees will be able to clearly understand the steps they need to take, and the order in which they are to be performed. Another important aspect she will take up for discussion is the structure of an Investigation report which properly documents the investigation.

Valuable learning outcomes
Upon completion of this webinar, the participants will know the responsibilities of analysts and supervisors, will have a clearer idea of what the FDA looks for in terms of human errors, the factors that trigger a full investigation, understand the frequency for re-testing and re-sampling, and learn how to implement the corrective and preventive action (CAPA) plans.
Aimed at personnel in laboratories who handle tests and their results, which includes Quality Assurance/Quality Control Directors, Managers, and Specialists, Regulatory Affairs/Regulatory Compliance Directors, Managers, and Specialists, and Quality Control Laboratory Staff; this webinar will cover the following areas:

 Guidelines for Detecting an OOS or Atypical Result
o Definition Atypical or Out of Specification Result?
o Review of the FDA Guidance for Industry on Investigating OOS Test Results
 Phase I: Initial Laboratory Investigation
 Phase II: Full Scale Investigation
o Root Cause Analysis Methods
 5 Whys
 Flow Charts
 Checklists
 Fishbone Diagrams
 Testing the hypotheses regarding potential root causes
o Retesting
o Considering Other Batches
 Developing a proper CAPA plan to address any Corrective Actions
o How to properly document findings
o Example of a proper OOS investigation write up.