Writing Job Description & Standard Operating Procedures in International Organizations
Course Objectives
• Define a Standard Operating Procedure (SOP)
• Explain the regulatory and human subject protection rationale for SOPs.
• Conduct an assessment (gap analysis) of the organization for SOPs.
• Identify the components, standards and requirements for SOPs.
• Practice writing an SOP.
• Prepare for an audit of the organization's SOPs.
• Describe Good SOP Management Practices.
Course Topic Overview:
• Good business practices and regulatory requirements for SOPs
• Identifying the need for SOPs and associated documents
• Preparing to write and SOP
• Individual Components of SOPs
• Implementation and management of SOPs
Key Learning Outcomes:
• Have a clear understanding of the requirements for SOPs in clinical research
• Explored options for template setting and layouts for SOPs
• Have written an SOP based on the principles covered
• Be able to identify the need for SOP within your environment
• Personnel who are required to write/review
• SOPs
• Personnel with a responsibility for quality
• management
• Personnel with an interest in understanding
• more about SOP
Benefits
• Proven strategies to ensure usable SOPs
• Techniques that make SOP writing easy
• Methods to help writers anticipate and prevent problems
• Useful techniques to write user-friendly SOPs
• Valuable tips for writing the various sections of SOPs
COURSE AGENDA
DAY ONE
Systems and Controls
• Introductions
• Document integrity and control
• Regulatory requirements and good business practices
• Determining which process documents to put in place
• Documents for overall systems and specific activities
• Process documents and their relationship to other documents
• Preventing overlaps, contradictions, and disconnects
Writing Effective Policies, Procedures, Instructions, and Methods
• Components of Standard Operating Procedures, instructions, and methods
• Controlling sequence of actions
• Choosing the correct voice
• Using the present tense
• Writing about conditions
• Avoiding ambiguity and redundancy
• Using parallel structure
• Being consistent from document to document
Procedure Writing Workshop
• Writing a procedure
• Assessing the process
• Refining it on paper
DAY TWO
Manuals and Plans
• Know your audience
• Components of quality manuals
• Components of Chemical Hygiene and other plans
• Identifying responsibilities
• Explaining systems and activities
• Controlling voice
• Writing section by section
• Controlling sentences
Refining Style
• Precision - making every word count
• Identifying false language rules
• Participants - grammar concerns
• Language bugbears and how to avoid them
• Punctuating for clarity
• Establishing a non-binding style guide
Reviewing and Revising
• Finalizing the document for review
• Peer review
• Formal review - author and reviewer roles
• Making sure the components are in place
• Refining the purpose and scope
• Assessing and improving the flow
• Making comments on review documents
Remaining Compliant
• Periodic review cycles
• Building document histories
• Revisions and impact on other documents
• Setting reasonable time frames from planning to active document
• Training on procedural documents
• Remaining compliant
DAY THREE
• Work break down structure
• Logical network diagram
• Bar charts & activity calendar
• Job analysis formats & 4 types of methods
• Writing Job description & specification
• Website learning
