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Home  >  Conferences  >  Writing Effective SOP and Other Process Documents
Conference Brochure

Writing Effective SOP and Other Process Documents is organized by The Center for Professional Innovation and Education (CfPIE) and will be held from Dec 06 - 07, 2018 at Hilton Berlin, Berlin, Germany.

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.

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

Conference Details

Session Details : View Session Details
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Registration Desk

Contact No. 1-610-648-7550
Email
info@cfpie.com

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Venue Address

Hilton Berlin
Mohrenstrasse 30
Berlin, Berlin, Germany

Official Hotel

Hilton Berlin,

Mohrenstraße 30,

Berlin, Berlin, Germany 10117,

+49 30 202300

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Hotels Near Venue

Hilton Berlin
0.03 miles from venue
The Mandala Suites
0.14 miles from venue
Free Wifi
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Session Details

Session Topic Start Time End Time Location Description Speakers
Writing Effective SOP and Other Process Documents 06 Dec 09:00 AM 06 Dec 05:00 PM Berlin Germany Course Description Course runs 9 00 to 5 00 both days Breakfast Lunch Included 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
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Workshop Details

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