Good Documentation Practice and Record Keeping Regulations (FDA & EMA)

In this webinar, we will discuss the definition, purpose, importance of GDP, General rules of GDP, GDP as it applies to laboratory notebook documentation, US Pharmacopeia General Chapter <1029>, and introduction “Good Documentation Guidelines”. We will also briefly introduce you to the European Union (EU) GDP, and its enforcement along with some observation samples from FDA.

Why Should You Attend:

Good documentation Practices (GDP) is an essential factor that needs to be closely followed by the personnel in any regulated environment as a process for a successful project completion including observations of unanticipated responses that are required to be accurately recorded and verified.

This 60-min Webinar covers the essentials of GDP, its definition, purpose, and importance. Then expands on general rules and principles of GDP (US & EU), General tips for Laboratory Notebook documentation and finally discussing GDP enforcement by regulatory bodies in different countries with some examples of FDA citations.

If you are involved in any product manufacturing, knowing GDP regulations is a must for you. It prevents a lot of errors and minimizes the chance of being spotted by the regulatory bodies in their audits.

Areas Covered in the Webinar:

The outline of this training includes:

• Definition, Purpose, and Importance
• General Rules and Principles of GDP
  • Requirements of Records
  • General Tips in GDP:
    • Signature / initial and the meaning
    • Copying records
    • Document maintenance
    • Recording the time and date
    • Correction of errors
    • Rounding rules
    • Back dating
    • Missing data
    • Voiding / cancelling records

Frequently Asked Questions:

1. Can you explain why blue pen is not acceptable?
2. Anything specific in document retention requirements in EU?
3. In the U.S., how long do documents have to be kept after the completion of a project/ clinical trial?
4. Related to 'what to do in case of errors': when mentioning the reason for error do you notate and include explanation it on the bottom?
5. Can paper documents be destroyed if electronic copies are kept of documentation?
6. What kind of original documents can’t be usually destroyed?

Who Will Benefit:

This webinar is applicable to the Medical Device and Pharmaceutical industries. Titles includes:

• Anybody who works in a regulated environment
• Manufacturing & Production Personnel / Managers
• Research and Development Personnel (R&D) / Managers
• Quality Assurance & Quality Control Personnel / Managers
• Laboratory Personnel / Managers
• Validation Specialists
• Clinical trial personnel
• Project Managers