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43 - MDC - Medical Sciences and Clinical Research


MDC 405 - Writing Effective Standard Operating Procedures SOPs

Code Start Date Duration Venue Fees
MDC 405 20 December 2020 5 Days Istanbul $ 3450 Registration Form Link
MDC 405 31 January 2021 5 Days Istanbul $ 3450 Registration Form Link
MDC 405 28 February 2021 5 Days Istanbul $ 3450 Registration Form Link
MDC 405 28 March 2021 5 Days Istanbul $ 3450 Registration Form Link
MDC 405 25 April 2021 5 Days Istanbul $ 3450 Registration Form Link
MDC 405 23 May 2021 5 Days Istanbul $ 3450 Registration Form Link
MDC 405 20 June 2021 5 Days Istanbul $ 3450 Registration Form Link
MDC 405 15 August 2021 5 Days Istanbul $ 3450 Registration Form Link
MDC 405 12 September 2021 5 Days Istanbul $ 3450 Registration Form Link
MDC 405 10 October 2021 5 Days Istanbul $ 3450 Registration Form Link
MDC 405 07 November 2021 5 Days Istanbul $ 3450 Registration Form Link
MDC 405 05 December 2021 5 Days Istanbul $ 3450 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