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Introduction

Formal written Standard Operating Procedures (SOPs) are required both by the Food and Drug Administration (FDA) and European Medicines Agency (EMA). Almost every deficiency identified in FDA's 483s and Warning Letters can be traced back to deficiencies in SOPs at an organization. SOPs are often inadequate, miss important elements, do not contain important tools to increase compliance with the SOPs and many times are hard for the personnel who follow them to understand. They are frequently poorly written, communicated, monitored and enforced.

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Scottsdale Marriott Suites, 7325 East 3rd Avenue, Scottsdale, 85251, United States

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2600 E. Bayshore Road, Palo Alto, 94303, United States of America
+1-650-620-3915
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