Writing Effective Standard Operating Procedures and Work Instructions

June 28, 2017· Ended
Conference
Fremont, United States
In Person
Deadline: June 27, 2017

About This Event

Description
Standard Operating Procedures and Work Instructions - the documentation required by regulation - is essential to the effective and compliant running of any regulated business. Unfortunately, many individuals in those businesses miss the valuable opportunities that properly developed Standard Operating Procedures/Work Instructions can provide. Regulated documentation can serve a variety of purposes other than meeting a regulatory requirement - as training materials, to standardize operations, to manage individual and group performance, to identify the sources of deviations, etc. The key is to knowing how to write those documents to properly meet those needs.

Objectives Of The Presentation
Discuss the regulatory requirements as they relate to SOPs and Work Instructions within the US and the EU
List and describe the benefits that effective regulatory documentation can provide the organization - specify the value add
Explain how regulatory documentation can serve as a significant component of any technical training program
Discuss why it is important to have a documentation hierarchy
Explain how best to determine/identify your regulatory needs and gaps in the regulatory portfolio
Explain the importance of having user-friendly documentation templates as the basis of your documentation process
Explain how to best gather technical information for regulatory documentation - efficient, effective, and technically accurate
Explain how to best work with subject matter experts to develop regulatory documentation
Explain writing styles, formats, and content requirements that must be addressed to prepare effective documentation
Explain the documentation development process to include how reviews and revisions are best addressed
Why Should you Attend
Writing effective Standard Operating Procedures (SOPs) and Work Instructions is not intuitive, it is not a skill that is often taught in our universities, and it can be a difficult and cumbersome task to execute. Knowing the most effective and efficient processes for gathering, organizing, and writing technical documentation is absolutely critical to providing significant value to a dreaded, avoided, and seemingly unimportant work task.

Areas Covered
The true purpose and function of regulatory documentation
What is the value add?
The pitfalls associated with writing regulated documentation
The documentation hierarchy
Documentation formats
Gathering the technical information you need
Using Subject Matter Experts
Documentation writing tips
Managing technical document reviews
Who will Benefit
Quality
Production
Compliance
Engineering
R & D
Management - essentially everyone in the organization that is tasked with creating regulatory documentation
Pharmaceuticals, Medical Devices, Biotech, API Manufacturers, Chemicals, Foods, Beverages, Cosmetics, etc.

For Registration
https://www.onlinecompliancepanel.com/webinar/WRITING-EFFECTIVE-PROCEDURES-WORK-INSTRUCTIONS-509265/AUGUST-2016-ES-WORLDCONCAL

Note: Use Promo code HY4LZ and get 10% off on registration (Valid till JUNE 30th 2017)

Event ID: esfjwz3

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