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.
This course has been pre-approved by the Regulatory Affairs Professionals Society (RAPS) as eligible for 12 credits towards a participant's RAC recertification upon full completion.
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
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.