Good Documentation Practices for Laboratory Operations
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, laboratory personnel need to be informed of these requirements, recognize their significance to their job and be aware of the consequences of non-compliance. 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. GMP compliance (21CFR, Part 211 and Eudralex, Volume 4) requires the use of good documentation practices. These practices apply to all pharmaceutical manufacturing and support areas. Good Documentation Practices describe 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 webinar, you will review agency and industry standard expectations of Good Documentation Practices plus see examples of these practices (both good and bad!) as they apply to the pharmaceutical laboratory.
Why Should You Attend:
- Discover what the FDA and EU regulations say about documentation
- Learn what your signature and/or initials mean on a document
- See how to handle and manage data entry and errors
- Review "Do's" and "Don'ts" of documentation practices
- Discuss rounding and limit expression determinations
- Recognize how to sign, date and label data and records
- Identify non-compliant documentation practices
- Demonstrate how to attach raw data to forms and lab notebooks
- Explore what FDA investigators actually look for during a lab inspection
Areas Covered in the Session:
- 21CFR and Eudralex references to documentation
- Correcting errors and omissions
- Dates and formats
- Meanings of initials and signatures
- Use of "NA"
- Comments and explanations
- Handling raw data (charts, strips, printouts)
- Blanks
- Entering numerical data
- OOS Documentation Expectations
- FDA Investigator strategies
Who Will Benefit:
- Chemists and Analysts
- Laboratory Technicians
- Laboratory Supervisors
- Laboratory Managers
- QA Auditors of Laboratory Documents
- Metrology personnel