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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	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

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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
Understanding how to prevent overlaps, contradictions, and disconnects in documents
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
Understanding the industry standards for procedure writing
Knowing how to review and revise documents
Understand the full life cycle of SOPs and other 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

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SAHARA Group Training and Consultancy INC (in Turkish: SAHARA Group Eğitim ve Danışmanlık AŞ)

Tax Office: Beyoğlu (Istanbul/Turkiye,Tax No: 7390525151 (Vergi Dairesi: Beyoğlu (İstanbul), Vergi No: 7390525151)

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44 - MDC - Medical Sciences and Clinical Research

MDC 405 - Writing Effective Standard Operating Procedures SOPs

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Course Objectives

Who Should Attend?

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