Pharma / BiotechMedical Device
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.
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.
Systems and Controls
Tense and Voice in Process Documents
Writing Effective Policies, Procedures, Instructions, and Methods
Procedure Writing Workshop
Manuals and Plans
Reviewing and Revising
Upon completion of this course, you will:
"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 verbage 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
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."
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.
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.
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The Center for Professional Innovation and Education (CfPIE) provides technical training for Pharmaceutical, Biotech, Medical Device and Skin/Cosmetics professionals. CfPIE offers more than 350 class sessions annually across 80 course titles in multiple formats, such as classroom, on-site and certification programs.
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