“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. This webinar will cover the basics of what good documentation practices include, along with examples of practices not acceptable to auditors. This webinar will help attendees review their own procedures and what should be included in applicable training sessions for new employees along with refresher training for those who are more experienced.
Areas Covered in the Session :
- 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 give to companies
- Interactive Q&A Session
Who Will Benefit:
- Production personnel
- Laboratory personnel
- Batch record reviewers
- QA Auditors
- Validation personnel
- Quality Engineering
- Maintenance personnel
- Warehousing personnel