Good Documentation Practices for GMP Operations


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 employees must follow good documentation practices.

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) 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 1-hour webinar, we will review the Good Documentation Practices plus demonstrate examples of these practices (both good and bad!) as they apply to the pharmaceutical arena.

Why you should attend:

The Learning Objectives of this presentation include:
Discover what the regulations say about documentation practices
Learn what your signature and/or initials mean on a document
See how to correct errors and omissions in data entry
Learn "Do's" and "Don'ts" of documentation practices
Learn how to attach raw data to records
Review rounding and limit expression determinations

Areas Covered in the Session:

21CFR Part 211 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)
Entering numerical data

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

Kerry gained his pharmaceutical manufacturing experience during his 28-year career with Merck. His career spanned the areas of Quality Operations, Audits & Inspections, Laboratory, Human Resources, and Learning & Development. More specifically, his responsibilities included quality management of laboratory assessment, site GMP lead auditor, FDA QSIT/Quality Management System manager, 5S coordinator, GMP trainer (annual, ongoing, new hire), OSHA regulations and Process Safety Management training, as well as internal and external public relations.

Quick Contact:

USA Phone:800-447-9407
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