Technical and Regulatory Writing for FDA Regulated Industries 2015 is a course that covers topics such as:
- How to edit, format, present and publish technical regulatory documents for most favorable reception by regulatory agencies
- Practical tips using examples on how to organize and deliver information in clear and readable documents
- Technical, practical, logical and logistical tips for all regulatory writers
- Rules for writing documents intended for electronic submission to regulatory agencies
Technical and Regulatory Writing for FDA Regulated Industries 2015 brings together:
- Medical and technical writers
- Regulatory affairs professionals preparing IND, DMFs, NDAs and other submissions
- Supervisors and lead workers in regulatory affairs
- Project managers and directors
- IT professionals looking to make eCTD submissions
- Quality assurance and quality control