Good Documentation Practices in a Regulated Environment
Overview:
Whether you work in production or in a laboratory or if you conduct investigations or finalize product release, sound data and information is essential to success and compliance.
To ensure success, and avoid those frustrating, embarrassing discussions of missing or doubtful data, employees recognize and must follow Good Documentation Practices (GDP). These practices apply to all pharmaceutical and medical device manufacturing, and their support areas. GDP describes the required activities and steps to use when recording data and other handwritten entries. Personnel, who work with documentation must be informed of these requirements, recognize their significance to their job and be aware of the consequences of non-compliance. During this 1-hour webinar, we will review the applicable US and EU expectations of documentation plus demonstrate examples of these practices (both good and bad!) as they apply to the pharmaceutical arena. According to the FDA, if it isn't written down, it didn't happen. As well, if it isn’t written down clearly, it didn’t happen either. Don't let poor documentation practices become a compliance issue for your company.
The Learning Benefits/Objectives:
- What the regulations say about documentation practices
- Meanings of your signature and/or initials on a document
- How to correct errors and omissions
- Current and correct use of "NA"
- Attaching raw data to records
- Date and time formats
- Rounding and limit expression determinations
Areas Covered in the Session:
- 21CFR and Eudralex references to documentation
- Signatures and signature logs
- Comments and explanations
- Entering numerical data
- Handling raw data (charts, strips, printouts)
- Blanks
- "Do's" and "Don'ts" of documentation practices
Who Will Benefit:
- Production personnel (operators, supervisors)
- Laboratory personnel (chemists, technicians, supervisors)
- Batch record reviewers
- QA Auditors of Production and Laboratory Documents
- Validation, Engineering
- Maintenance personnel (mechanics, supervisors)
- Warehousing personnel