Industries: Pharma / BiotechMedical Device

Writing Effective SOP and Other Process Documents

Writing Effective Standard Operating Procedures (SOP) and Other Process Documents

Course Director: Kay Monroe

Course Fee: $2150.00 Regular Registration / $1950.00 Early Bird (30 Days in Advance) 

Course Description -

This course presents a comprehensive overview of process writing that the binding regulations require. There's a tenet among regulatory bodies: "If you didn't write it down, it didn't happen," and while the regulations tell companies what they need to do and document, they don't tell them how. Determining how systems work and how processes occur and documenting them is up to companies to assess. This course presents process writing within the "big picture" of controlled documentation and gives industry standards for delivering information. Effectively prepared process documents keep companies on track and compliant. Participants will learn how to write documents that ensure consistency in operations. A workshop in process writing gives participants the opportunity to actually write about a process and then assess the results.

The course also addresses problematic areas of the English language and affords participants the chance to voice their questions. Participants will learn how to tighten and refine the language to produce clear and comprehensive documents.

Who Should Attend

This is a course for people who must write process documents required by the binding regulations. Process documents in sum create a procedural infrastructure that delineates the company's activities. These documents include Standard Operating Procedures (SOPs); policies; work instructions; laboratory methods; emergency action, chemical hygiene, animal husbandry and other plans; and quality manuals. This course is valuable for pharmaceutical, medical device, and biotech professionals in drug discovery, product development, quality assurance, clinical testing, information technology, and regulatory affairs. It is also helpful for senior and middle management executives who want to familiarize themselves with the regulations that mandate procedures and the industry standards for writing them, putting them in place, and remaining compliant.

Course Agenda

First Day

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

Second Day

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

Learning Objectives

Upon completion of this course, you will:

  • Understand the mandates for clearly delineated processes set forth by the Food and Drug Administration (FDA), International Conference on Harmonization (ICH), Occupational Safety and Health Administration (OSHA), the International Organization for Standardization (ISO), and other governing bodies
  • Have increased understanding of the role of written procedures in maintaining effective and compliant business activities
  • Understand the importance of document integrity and established controls
  • Understand how to prevent overlaps, contradictions, and disconnects in documents
  • Have increased confidence in planning and writing various process documents
  • Understand how English tenses work and how they serve to make process documents clear and logical
  • Understand how to write in the third person, use the imperative voice, and pare the passive
  • Be able to control the language so that every word counts and messages are clear to readers
  • Know the answers to your questions about language anomalies
  • Understand the industry standards for procedure writing, including typical components of documents, and using document templates
  • Know how to review and revise documents
  • Understand the full life cycle of SOPs and other documents
  • Understand how training is integral to document approval
  • Know how to build a non-binding style guide to support the writing process


"Great Course! This course was FANTASTIC, and the materials were more comprehensive that other trainings! The director was extremely knowledgeable and had clear answers to all our questions. The director’s experience is apparent and it’s refreshing to have training from an expert. I wish she worked for our company!" Francis, Assoc QA Manager, MTF Biologics
"This was a superior training course compared to ones I have taken with other training companies. The course director was knowledgeable on the topics and was able to engage the participants and challenge thinking norms while being very mindful of regulatory compliance. There are no improvements needed to this course!" Simon H., R&D Engineer, MTF Biologics
"This course was customized and delivered on-site and the Director was able to use her experience and expertise to answer questions that were specific to our company’s operations. It was definitely a good use of my time (this has not always been the case with courses from other providers)." Sharon, Manager Document and Change Mgmt., MTF
"Great Course! This course was very informative in areas relative to my current position. Many courses I’ve completed from other providers were not as informative. I found the course aligned with all aspects of my company’s document control and I will use all the tools provided." Sherrie S., Doc Control Specialist, Mallinckrodt
"This is my first off site training and I really enjoyed the openness and interaction with the other participants. It was great." Jonnice T., QA Compliance Coord., PharmaChem Technologies
"The Course Director was knowledgeable and has a vast amount of experience in Biopharma, as well as R&D. The course was very relevant to the SOP, review and approval process." Nikki, QA-ATS, AstraZeneca
"I feel your expertise could help PDA Task Force authors. I would recommend you, if it were in my power, as an industry speaker at one of our signature conferences." Iris D., Manager, Scientific and Regulatory Affairs, Parenteral Drug Association (PDA)
"The Course Director made this class very exciting and a great team building event. I learned a lot during this class, especially the verbiage used in federal regulations and compliances. She also provided charts, slides on Pharma R&D spending and drug development cycle." Bala R., Senior Analytical Chemist, Mallinckrodt Pharmaceuticals
"Thank you for such a comprehensive, thorough coverage of the topic. I enjoyed the exercises and discussions. The instructor was very knowledgeable and engaging. I feel much better prepared to tackle my next SOP writing project. I really appreciate how well-organized the event was." Elizabeth M., Contractor
"This course is exactly what I was looking for. The skills I've learned can be applied to my job immediately. The information was very straight forward and presented in a way that was easy to understand." Matthew M., Field Application Engineer, CEIA Metal Detectors
"Excellent instructor. Course materials were excellent. I left with a feeling of being able to handle my documents with confidence." Amanda B., Document Control Specialist, International Vitamin Corp.
"The training was helpful in emphasizing being consistent and concise. Kay was engaging and knowledgable." Shao H., Research Manager, Mallinckrodt Pharmaceuticals
"I rarely provide such glowing feedback, but the Course Director was exemplary in her delivery of the material." Barry C., Software, QA Engineer, Medtronic
"This course met all my expectations. I will strongly recommend this course with my colleague. I know that I will go home and start reviewing the SOPs in my department and start to improve them." Linda H., DRA Team Leader, Actavis
"The information was very informative and helpful. I would recommend it to anyone in document control." Denise S., Document Control Specialist, Shire
"The instructor was very well-versed in the industry and could relate to the specific needs of the audience. She presented the material in an engaging manner." Brad G., Staff Formulation Scientist, Mallinckrodt Pharmaceuticals
"I really enjoyed this course and want to attend the Document Management class is September. I will recommend this course material to my colleagues at N.I.H. It was an informative and enjoyable class for all who attended" Aleecia Q., Clinical Trial Specialist, Henry Jackson Foundation, N.I.H.
"The Course Director is a strong presenter in this subject area and very well versed. Great dynamic sessions, lots of engagement and sharing from peers." Jeanette H., Director, Procedures and Compliance, Wyeth
"The Course Director was an excellent instructor. She facilitated excellent discussion amongst the class members. I like her style of teaching and would definitely take another one of her courses. The Desmond also treated us like royalty." Diana C., Global Quality Management, J&J
"I found this course to beneficial to me in aiding and improving my writing. The class provided ideas which I will be able to implement into my job." Krysta S., Procedures Analyst, Wyeth
"Course Directors extensive knowledge and experience in the pharmaceutical and related industries was very helpful and her English background made this a very good course." Document Manager, Eli Lilly
"Great! Very useful interaction with other professionals facing the same issues." Maurice A., Aventis

Frequently Asked Questions

Doesn't FDA expect to see wording in SOPs similar to that in the CFR?

No. SOPs are best in the straightforward language of the people who adhere to them. SOPs are working documents that serve as the operating laws for the company, so they must be clear to their audience - the workforce. SOPs tell, in essence, how the company complies with the CFR and other regulations, which tell what companies must do, but don't say how. That's the role of SOPs - they explain "how it happens here." That also means SOPs should be in the present tense to indicate habitual, repeated action, not the legalese and future tense of the regulations which use "shall."

What is a quality manual and where is it required?

The Quality System Regulation for medical devices calls for a quality manual that defines responsibilities from the CEO down (CFR 820.20). The regulations for pharmaceuticals and biologics do not include this requirement. However, FDA's guidance "Quality Systems Approach to Pharmaceutical Current Good Manufacturing Practice Regulations" says that FDA has seen a need "to harmonize the GMPs with other non-U.S. pharmaceutical regulatory systems and with FDA's own medical device quality systems regulations." It is thus likely that quality manuals will become standard documentation for all therapeutic product companies.

Why do we need SOPs to operate equipment when manufacturers provide operator manuals?

SOPs are mandatory for product-related processes, and operator manuals cannot replace them. Manufacturers' operating manuals offer general information for using and maintaining equipment that may be suitable for many purposes, including your applications. Manuals do not identify use of the equipment within your facility, nor do they say who is responsible for processes and who carries them out. Further, manuals are not controlled documents subject to periodic review and revision and thus may not remain current to your needs. Your SOPs, through your change control process, will reflect any improvements you make to your processes over time.