Biopharmaceutical & Pharmaceutical Training & Technology, Medical Device & Biotech Training - CfPIE
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Writing Effective Standard Operating Procedures & Other Process Documents


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

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

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 timeframes from planning to active document
  • Training on procedural documents 
  • Remaining compliant

RETURN TO COURSE DESCRIPTION




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Malvern, PA 19355
Phone: 610-688-1708