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Standard Operating Procedures (SOPís)
Regulatory Agencies require written procedures for all systems and operations which impact the quality and safety of pharmaceutical products. Standard Operating Procedures (SOPís) provide the main forum for the documentation of a Companyís systems and operations. SOPís are therefore among the main documents audited by Regulatory Agencies during GMP inspections to ensure they reflect current practices and are followed as written. This course provides helpful information by presenting topics associated with the writing, formatting, execution and management of SOPís. The course material is presented by means of slides, handouts and participation of the attendees through discussion and group exercises.
The course reviews the regulatory requirements of SOPís and their role in global harmonization and good documentation practices and GMP. It then launches into a series of topics, interactive exercises and group discussion on how to write effective SOPís and manage and maintain this critical documentation system. It enables participants to gain the skills and knowledge necessary to meet the FDA, Health Canadaís and other regulatory agenciesí expectations.
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