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Good SOP Practice: Processes and Authoring

Level:
Foundation
Area:
Drug Development
Code:
DDF18
Duration:
03:30:00
Workshop profile:
Medical writers working in clinical research organisations or the pharmaceutical company environment, as either employees or as freelancers. The workshop will meet the needs of writers following, reviewing and revising existing Standard Operating Procedures (SOPs), or creating new SOPs. This is an ideal forum for writers whose organisations or clients have scope to improve their SOPs.
Objective:
• To view SOPs from several perspectives and use this valuable multi-dimensional view in SOP development • To link process to writing and reviewing from the outset • To discuss good (and poor) SOP practices in detail • To put theory into practice using in-workshop exercises • To place SOPs in the current context by considering their place and management in the electronic environment • To understand how to create and maintain good SOPs or review existing SOPs
Content:
• What is an SOP? • Why do we need SOPs? • Using, reviewing and creating SOPs: A multi-dimensional perspective • SOP components • Planning the SOP • Language and authoring tips • SOPs in an electronic age