Objectives of the Presentation
Why Should you Attend
- Learn some quick formatting tips that will make writing immediately more readable
- Learn how to use formatting tools in a way to maximize the impact of their writing in an electronic system
- Learn how to format SOPs to facilitate clarity
- Learn how to document investigational information in a way that is understandable to non-technical professionals
- Learn how to author change records that explain the rationale for change in clear, non-technical language
Advanced technology may have pushed effective communication to the wayside to make clear writing a lost art, now due for revival. In the Information Age, a surplus of technical data proliferates with very little information communicated in plain language. Unclear communication can confuse compliance auditors who need to quickly assess whether an unfamiliar organization fulfills requirements. Poor writing therefore can contribute to an audit communication breakdown, leading to undesired audit findings.
This webinar will focus on effective communication of technical information so that an external auditor will quickly understand it and credit your organization with doing the job right.
Who will Benefit
- General technical writing guidelines
- Tips to improve readability and understanding of your documents
- Guidelines for SOP writing
- Guidelines for writing investigation findings
- Guidelines for writing change records
- Proofreading your work
This webinar is aimed at pharmaceutical and medical device professionals with scientific expertise, who struggle with documenting information so that it is understandable to non-technical professionals.
- Pharmaceutical and medical device professionals
- Technicians taking on more authorship duties
- Document authors
- Subject-Matter Experts wishing to share their knowledge
- Medical writers and anyone who writes or want to write
- Regulatory affairs personnel
- Quality assurance personnel
- Information technology personnel
- Vice presidents, Directors and Managers
- People interested in investing in the FDA-regulated industry
Regulators have a number of expectations when they come to inspect a facility that manufactures medical products. They expect that policies and procedures are available, and understood by everyone who uses them. They expect that all equipment, policies, and procedures be in a state of control, and that changes to these are managed through a well-defined change control system. They expect that the records for these changes be accessible and scientifically justified. Furthermore, in the event of any unexpected occurrences, regulators expect that there be a well-defined investigation process that clearly identifies the root cause, how the root cause was identified, and any supporting data. All of this can be a challenge two technical professionals who understand the technical aspects of their jobs, without the background necessary to document their knowledge in a clear, concise way so outside regulators understand it. This webinar introduces the technical professional to some tips and tricks to simplify the documentation aspects of their jobs.