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“Corrective Action Reports: What do I need and how do I make sure I give the regulator what they want?”

Every 2-3 years laboratories open their doors to the regulators for on-site assessments. You prepare you labs, records, and staff for a week of the unknown. After the regulators leave…the real work begins…fixing the deviations. How you prepare and describe your corrective actions is as important as actually fixing the deviations. This talk will help you navigate not only the correction of the deviation, but how to investigate other areas of your lab, how to train your personnel, and finally how to write it all up so that your written report clearly describes all of your hard work. 

Presenter: Aaren Shaffer Alger, Alger Consulting & Training, LLC

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