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.



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

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.

"The information was very informative and helpful. I would recommend it to anyone in document control."
Denise S., Document Control Specialist, Shire

"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