Responding to Clinical Observations: Developing Robust Audit & Inspection CAPAs

Kelly Thomas

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$349


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In a pharmaceutical clinical trials environment, just about anyone can find themselves in the hot seat during internal audits and regulatory inspections. Diligent, proactive companies provide various levels of inspection readiness for employees. The primary goal of an inspection readiness program is to avoid observations. However (and, despite your best efforts) audits and inspections do result in observations for many companies.

Next, after the initial shock of your observations wears off, robust Root Cause Analysis (RCA) is conducted and an appropriate Corrective and Preventative Action (CAPA) is determined.  However, your work is just beginning.  What most of industry doesn’t understand is that how you write  your CAPA is critical in getting agreement with the regulators.  Poorly-written CAPAs can lead to confusion and – worst of all – repeated observations.

Don’t find yourself beautifully prepared for your audit or inspection then unprepared for the aftermath.  This course will teach you how to use  SMART (Specific, Measurable, Achievable, Results Oriented, and Time-Bound) goals as a framework to draft submission-ready CAPAs that not only adequately address observations, but also make sense for your organization.  Anecdotes and examples will be provided to lend context, and tools shared to give you the confidence to write an amazing CAPA.

LEARNING OBJECTIVES

At the completion of this session, you will be able to…

·Appropriately interpret an observation (the first step to developing an appropriate response)

·Identify the key expected elements of a great CAPA

·Write a CAPA that is both grammatically correct and specifically addresses the observation

·Use SMART (Specific, Measurable, Achievable, Results Oriented, and Time-Bound) goals to craft your CAPA

· Select appropriate CAPA owners and timelines to ensure that the observation can be tackled and closed out within a reasonable timeframe

 

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Training CD-DVD

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


Recorded video

Recorded video session



Speaker: Kelly Thomas, Vice President, Americas Quality Operations

Ms. Thomas has over two decades of cGMP hands-on industry experience in both pharmaceutical and medical device manufacturing operations. Her experience covers all Quality Systems; as well as, all areas of validation; including, process/product validation, facilities validation, CSV and 21 CFR Part 11, test method validation, equipment/automated processes and cleaning validation.

Utilizing strategic thinking, risk-based approaches, and Lean principles, she has demonstrated success in steering and managing complex projects within the pharmaceutical and medical device industries.


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