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44 - MDC - Medical Sciences and Clinical Research
MDC 405 - Writing Effective Standard Operating Procedures SOPs
| Code | Start Date | Duration | Venue | |
|---|---|---|---|---|
| MDC 405 | 22 April 2024 | 5 Days | Istanbul | Registration Form Link |
| MDC 405 | 20 May 2024 | 5 Days | Istanbul | Registration Form Link |
| MDC 405 | 10 June 2024 | 5 Days | Istanbul | Registration Form Link |
| MDC 405 | 15 July 2024 | 5 Days | Istanbul | Registration Form Link |
| MDC 405 | 12 August 2024 | 5 Days | Istanbul | Registration Form Link |
| MDC 405 | 09 September 2024 | 5 Days | Istanbul | Registration Form Link |
| MDC 405 | 07 October 2024 | 5 Days | Istanbul | Registration Form Link |
| MDC 405 | 04 November 2024 | 5 Days | Istanbul | Registration Form Link |
| MDC 405 | 30 December 2024 | 5 Days | Istanbul | Registration Form Link |
Please contact us for fees
Course Description
Effectively prepared process documents keep companies on track and compliant. This course presents a comprehensive overview of process writing that the binding regulations require. Participants will learn how to write documents that ensure consistency in operations.
This course covers Standard Operating Procedures (SOPs), policies, work instructions, laboratory methods, emergency action, chemical hygiene, quality manuals, animal husbandry and other plans.
Course Objectives
- Understanding the importance of document integrity and established controls
- Having increased confidence in planning and writing various process documents
- Understanding how English tenses work and how they serve to make process documents clear
- Being able to control the language so that every word counts and messages are clear to readers
- Knowing how to review and revise documents
Who Should Attend?
- Pharmaceutical, medical device, and biotech professionals
- Senior and middle management executives
- Those involved in writing process documents required by the binding regulations
Course Details/Schedule
Day 1
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
Day 2
Tense and Voice in Process Documents
- Identifying the audience
- Using verbs to control action
- Using the active voice
- Paring the passive
- Writing in the third person
- Using the imperative voice
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
Day 3
Procedure Writing Workshop
- Writing a procedure
- Assessing the process
- Refining it on paper
Day 4
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
Day 5
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 timeframes from planning to active document
- Training on procedural documents
Remaining compliant
