2011 - Tips on Writing the Perfect Document to Impress the FDA

Why Should You Attend:
Formal and written Standard Operating Procedures (SOPs) are the keystone of good operations. SOPs create an important evidence and documentation for the regulatory compliance status of an organization and are one of the first things auditors wants to review when inspecting a site.

Almost every deficiency identified in FDA’s 483s and Warning Letters can be traced back to deficiencies in SOPs at the given organization. SOPs are often poorly written, communicated, monitored and enforced.

Attend this webinar to learn what exactly an SOP should contain, what should be its format and tone, who should write it, when and how should it be revised or retired, how many SOPs should be there, what activities do not need SOPs, how should SOP training be conducted and documented, and many other issues impacting the compliance with FDA requirements from SOPs.

You will learn how to take your current SOPs to a level that not only would demonstrate your expertise about your operations but also make it easier for your personnel to follow.

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