Unfortunately, many individuals in the life sciences miss the valuable opportunities that properly developed Standard Operating Procedures/Work Instructions can provide. Regulated documentation can serve a variety of purposes other than meeting a regulatory requirement – as training materials, as standard work to control operations, to harmonize operational controls across multiple facilities and borders, to manage individual and group performance, to identify the sources of deviations, and as the foundation of a sound continuous improvement process, The key is to knowing how to write those documents to properly meet those needs. The key is knowing how to do it right.
The approach and philosophy taught in this seminar are new to the industry and focus on achieving maximum benefit of compliance documentation across many applications to achieve both operational efficiencies and compliance excellence.
Why You Should Attend:
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 curriculuma 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.
DAY 1 : (9 AM – 5 PM)
Session 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
Session 2: The Rules of Technical Writing
– Understand the content
– Use signposts
– Don’t violate standards
– Technical terms
– Structuring and formatting your documentation – templates
– Harmonize your documentation
Session 3: 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
Session 4: The Technical Writing Process
– Analyze the audience
– The reader profile
– The project team
– Executional considerations
– Planning the content – the outline
Session 5: Gathering Technical Information – Working with Subject Matter Experts
– Relationship building
– Active listening
– Avoiding Assumptions
– Remove communication barriers
– Setting expectations
– The data gathering process
Session 6: Utilizing Graphics
– Types of graphics
– Typical photographs
– Digital photographs
– Typical schematics
– Tables and graphics
DAY 2 : (9 AM – 5 PM)
Session 1: Ensuring Accuracy and Utility
– Goals of the review
– Review the criteria
– What to look for
– The document review
Session 2: Technical Writing Basics
– Use clear and concise language
– Avoid jargon
– Define the unfamiliar
– Write clearly
– Make good word choices
– Be clear and concise
– Using active and passive voice
– Organize your content
– Separate action steps from information
Session 3: What are Tasks
– Grouping tasks
– Constructing action steps
– Using action verbs
Session 4: Grammar Mechanics
– All-inclusive words
Session 5: Special Considerations
– Non-native language considerations
– Controlled English
– Global English
Session 6: Technical and Process Descriptions
– Technical processes
– Procedures and work instructions
Charles H. Paul
C. H. Paul Consulting, Inc.
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