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Bulletproofing your cGXP Documentation from Audit Citations
Regulators consider documentation to be a critical entity. Consequently, they always audit documentation systems and it is rare to find audits where 483s for poor documentation have not been issued.
By attending this webinar, you will become familiar with what attributes contribute to good document development, the complexities and challenges posed by hybrid documentation systems and steps you absolutely need to take to ensure that your documentation system is bullet proof.
Developing documentation to meet regulatory approval involves activities that record information and data either electronically or on paper. These documents should be developed such that they promote the easy dissemination of the information/
Why Should you Attend:
The ability to write clear and concise documents is an essential skill required of those working in the Life Sciences industry. This course is ideal for all people who are required to create, complete and/or review documents in the Life Sciences industry.
Objectives of the Presentation:
At the end of the webinar, participants will:
Become aware of document types audited
Have exposure to examples of Quality attributes of documents
Understand the regulatory requirements for electronic documents
Become aware of the requirements for maintaining paper documents
Become familiar with SOP requirements that auditors look for
Review some Good Documentation Practices related 483s and WL
Who can Benefit:
Documentation System managers
QA Who review and approve raw data
Regulatory Affairs Submission Personnel