Applying Global Standards to Life Sciences Compliance Documentation
Duration : 60 Minutes
Charles H. Paul,
Charles H. Paul is the President of C. H. Paul Consulting, Inc. – a regulatory, training, and technical documentation consulting firm. Charles is a management consultant, instructional designer and regulatory consultant and has led C. H. Paul Consulting, Inc. since its inception over 25 years ago. He regularly consults Read more
The documentation required by regulation - to include standard operating procedures and work instructions - 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 know how to write those documents to properly meet those needs. Of late, there has been global guidance on how those documents should fit into the hierarchy of documents and how they should be structured to meet regulatory requirements. This webinar will address all of these areas.
Course Objectives:
At the completion of this webinar, participants will be able to:
• Discuss the importance of regulatory documentation
• Discuss the value add applications of documentation to training, human performance, and the regulatory function
• Explain and discuss what is wrong with documentation in our organizations
• Define the importance of establishing a documentation hierarchy and building effective documentation templates
• The new global hierarchy guidelines
• Electronic common technical document specifications
Why Should Y
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