Writing Standard Operating Procedures (SOPs)
Training Overview
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Comply with FDA requirements related to standard operating procedures to avoid regulatory action
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Identify where SOPs are mandated in the GMPs, GLPs and GCPs to maintain compliance
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Discover gaps and overlaps in your SOPs to strengthen existing documentation
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Apply proven writing techniques to new SOP development to help avoid costly rewrites
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Optimize organization and formatting of SOPs to enhance ease of use and save valuable time
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Implement effective document controls, including change control
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Facilitate the paperless trend by learning how to effectively comply with 21 CFR Part 11 for eSOPs
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Integrate SOPs with other corporate and site documents to create a seamless documentation package
PTi international is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmaceutical education. Participants will receive a maximum of 14 hours (1.4 CEUs) of continuing education credit for full participation in the two-day training. ACPE # 326-000-03-014-L04. Initial release: 03/2003.