This webinar will detail a step-by-step procedure on how to prepare a standard operating procedure (SOP) that is a practical, effective and compliant. Also learn how to review and revise SOPs and maintain compliance over the course of the SOP life-time.
WHY SHOULD YOU ATTEND
A large number of FDA's inspectional observations can be traced back to deficiencies in SOPs at an organization. SOPs are often inadequate, miss important elements, lack tools to increase compliance with the SOPs and, often are hard for the employees to understand them. They are frequently poorly written, communicated, monitored and enforced.
This webinar will provide guidelines on how to write standard operating procedures and work instructions for FDA-regulated organizations.
You will become familiar with the basics of how to generate a great SOPHow to remain compliant and yet not restrict the course of actionHow to maintain the compliance over the course of the SOP life time
Record compliance with examplesWhat are SOPs?Why are they important?What are their benefits?What are their limitations?Important types of SOPsMinimum number for SOPs, topics, and examplesSOPs and guidelinesSteps to develop an SOP:
Process mappingAuthoringFormatting and languageEditingAuthorizingTrainingImplementationRevision / archiving (version control)An SOP example and template
Standard Operating Procedures (SOPs) are required for companies that are regulated. However, there are no guidelines available by regulatory bodies on how to write, maintain, and update SOPs. Often, SOPs are prepared in a way that makes compliance difficult, leading to errors or delays that will be discovered during an audit.
Technically, all FDA inspections include an SOP review and it is very important to have them designed such that they are easy to maintain and update.
This webinar will instruct the participants how to write, maintain, and update SOPs to ensure compliance.
WHO WILL BENEFIT
Anybody who works in a regulated environment (manufacturing, R&D, labs, Lab managers, Clinical trial personnel)
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