Duration: 6 Hour


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This seminar will discuss how to transform your regulatory documentation process into a profit center, an operational force multiplier in how you run your business and the functions comprising it.

Writing Standard Operating Procedures and Work Instructions is technical writing but technical writing with a twist. In order to create effective documents, you need to know a lot. You first must know about the regulations that govern the subjects you are writing about, you must know how people will use the documents that you create in the performance of their work, you need to know how to work with subject matter experts to gather the information you need to complete your document, you need to know about human performance and how people best learn and perform, and you need to understand how to best create operational documents in terms of layout and the use of visuals and language. Finally, you must know how to write technically.

Unfortunately, technical writing is not a skill that is given much emphasis in college curriculum if any. Technical writing is a skill life science workers are assumed to have and are expected to demonstrate at a level of skill usually beyond the capability of most. Unfortunately, most readers of technical writing are in the “same boat.” They “don’t know a good one when they see one.” At the end of the day, in most cases, you have mediocre writing at best that may or may not convey the message intended.

So what will this seminar do for you? The short answer to this question is that this seminar will provide you with the skills you need to effectively complete the most frequent writing assignment that you will ever receive in the life sciences….writing standard operating procedures and work instructions. The seminar will make you aware of how to write technically making maximum use of the words you use.

During this seminar we will practice the skills for effective writing and good documentation practice by completing many exercises and simulations to practice applying the skills learned.

At the completion of this seminar you will know how to gather information for, structure, illustrate, and write these most important life science documents.

Areas Covered in the Session : 

  • Learn how to identify “GxP” Systems
  • Discuss the Computer System Validation (CSV) approach based on FDA requirements
  • Learn about the System Development Life Cycle (SDLC) approach to validation
  • Discuss the best practices for documenting computer system validation efforts, including requirements, design, development, testing and operational maintenance procedures
  • Understand how to maintain a system in a validated state through the system’s entire life cycle
  • Learn how to assure the integrity of clinical data that supports trial work
  • Discuss the importance of “GxP” documentation that complies with FDA requirements
  • Learn about the policies and procedures needed to support your validation process and ongoing maintenance of your clinical trial systems in a validated state
  • Understand the key components of 21 CFR Part 11 compliance for electronic records and signatures
  • Know the regulatory influences that lead to FDA’s current thinking at any given time
  • Learn how to prepare the essential files for a Trial Master File
  • Understand how an electronic Trial Master File (eTMF) can improve trial management
  • Know the clinical data files that are essential to collect before, during and after the conduct of a trial
  • Learn how to best prepare for an FDA inspection or audit of a clinical trial related computer system

Seminar Agenda:

Lecture 1:

Where do SOPs and Work Instructions Fit? – An Overview

  • The relationship between regulatory documentation (SOPs and Work Instructions), training and regulatory compliance, operational excellence and why it is important
  • The purpose and function of SOPs and Work Instructions
  • The Documentation and Operational Performance Model
  • The relationship of corporate knowledge to value and human performance

The Rules of Technical Writing

  • Readability
  • Understand the content
  • Use signposts
  • Don’t violate standards
  • Technical terms
  • Structuring and formatting your documentation – templates
  • Harmonize your documentation

Lecture 2:

Regulatory Compliance and SOPs and Work Instructions

  • Manage documentation
  • Where and why procedures are required
  • The need to be a successful writer in the life sciences

The Technical Writing Process

  • Analyze the audience
  • The reader profile
  • The project team
  • Executional considerations
  • Planning the content – the outline

Session 3: 

Gathering Technical Information – Working with Subject Matter Experts

  • Relationship building
  • Active listening
  • Paraphrasing
  • Questioning
  • Avoiding Assumptions
  • Remove communication barriers
  • Challenge
  • Compromise
  • Setting expectations
  • The data gathering process

Utilizing Graphics

  • Types of graphics
  • Typical photographs
  • Digital photographs
  • Drawings
  • Typical schematics
  • Flowcharts
  • Tables and graphics

Session 4:

Ensuring Accuracy and Utility

  • Goals of the review
  • Review the criteria
  • What to look for
  • The document review

Technical Writing Basics

  • Use clear and concise language
  • Avoid jargon
  • Define the unfamiliar
  • Brevity
  • Simplicity
  • Write clearly
  • Make good word choices
  • Be clear and concise
  • Using active and passive voice
  • Organize your content
  • Separate action steps from information

Session 5:

What are Tasks

  • Grouping tasks
  • Constructing action steps
  • Using action verbs

Grammar Mechanics

  • Grammar
  • Numbers
  • Abbreviations
  • All-inclusive words
  • Synonyms
  • Vocabulary

Session 6:

Special Considerations

  • Non-native language considerations
  • Controlled English
  • Global English

Technical and Process Descriptions

  • Technical processes
  • Procedures and work instructions

 Who Should Attend:

  • Human Resources Department Management and Staff
  • Training and Development Department Management and Staff
  • Operations Department Management and Staff
  • Manufacturing Management and Staff
  • Production Management and Staff
  • Engineering Department Management and Staff
  • Technical Services Management and Staff
  • Regulatory Affairs Management and Staff
  • Documentation Departments
  • Quality Assurance Management and Staff

Course Director: CHARLES H. PAUL ‎

Charles Paul is an instructional designer and management consultant with over 30 years’ experience providing training and consulting services to regulated industries. He has installed quality systems and designed and developed GMP and operational documentation and training programs for foods and beverage, pharmaceuticals, biotech, cosmetics, and consumer product – OTC industries.