Good Documentation Practices for GxP Compliance

Documentation is essential for good science. This is especially true in life sciences where FDA and other health authority regulations impose a special recordkeeping burden. In these industries, documentation serves both the scientific and compliance needs, and Good Documentation Practices (GDPs) are the set of activities that enable you to record your data and hand-written entries in a legible, traceable and reproducible manner.

Why should you Attend: 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, all employees must follow good documentation practices.

The use of GDP allows companies to comply with regulatory requirements such as Good Laboratory Practices (GLP), Good Manufacturing Practices (GMP) or the applicable quality management system (for example, ISO 13485, 21 CFR parts 11,211,312,and 820), or Good Clinical Practices (GCP).Documentation that is used in support of manufacturing, laboratory and clinical practices should adhere to GDP.

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. 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.

Areas Covered in the Session:

• Document System
• What is Documentation?
• Type of Documents
• Good Documentation Practices
• Good Documentation requirements
• Documentation Processing and Control
• Guidance documents for GDP

• Anyone who authors, reviews, and audits documents and records in FDA-regulated pharmaceutical, biotechnology, and medical device industries
• Clinical research associates
• Manufacturing/Production personnel
• Laboratory personnel
• Research and Development associates
• Document Control associates
• Batch record reviewers
• QA/QC specialists
• Validation engineers
• Quality Assurance auditors
• Regulatory Compliance Associates and Managers