Good Documentation Practice and Record Keeping Regulations (FDA & EMA)
Duration : 60 Minutes
Dr. Afsaneh Motamed Khorasani,
Dr. Afsaneh Motamed Khorasani, PhD, is a Medical and scientific Affairs expert and a Senior Scientist with a strong background in biomedical science and clinical trial/research. She has a tenured and diverse range of experience in medical affairs, basic and industrial clinical research and develop Read more
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.
Course Objectives:
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.
Following the completion of this webinar you will gain a basic to moderate knowledge of definition, purpose, importance of GDP, General rules of GDP, GDP as applies to laboratory notebook documentation, US Pharmacopeia General Chapter <1029> introduction “Good Documentation Guidelines”, A very brief introduction to European Union (EU) GDP, and finally its enforcement along with some observation samples from FDA.
Course Outline:
The outline of this 90 minute session includes:
• Definition, Purpose, and Importance
• General Rules and Principles of GDP
o Requirements of Records
o 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
• Recreating / rewriting records
• Deviations
• Rules Governing Medicinal Products in the European Union (Vol. 4: Documentation)
o What is new in the Latest Version?
• GDP Enforcement (examples from FDA warning letters)
What You Get:
• Training Materials
• Live Q&A Session with our Expert
• Participation Certificate
• Access to Signup Community (Optional)
• Reward Points
Who Will Benefit:
• 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
Please reach us at 1-888-844-8963 for any further assistance or if you wish to register
Contact Us
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