Training Course Syllabus:
Good Documentation Practices
Why Should you Attend:
"Good documentation practices" is a "current" industry practice that is reviewed and cited by federal regulators when audited. Pharmaceutical/Biological document are legal documents that are controlled by all regulatory agencies. The person or persons responsible for filling out these documents accepts the consequences if the documents are not filled out according to good documentation practices. Good documentation practices are expected to assure they are accurate, legible and traceable to name a few. The lack of such good documentation practices are routinely cited in FDA 483 observations. Attend this webinar to learn proper methods for documenting data in the highly regulated pharmaceutical industries.
You will take away a better understanding of how project management can assist you in performing your role in your organization.
Objectives of the Presentation:What is the definition of good documentation practices
Examples of documentation practices that should be avoided
Review of examples of good documentation practices and what they apply to
Review of practices for correcting mistakes or when space is limited for comments
Review of FDA 483 citations given to companies