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Background: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.
Why you must attend:
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 Session:
Following the completion of this On-Demand 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.
Purpose, and Importance
- General Rules and
Principles of GDP
- Requirements of
- General Tips in
- Signature /
initial and the meaning
- Copying records
- Recording the time
- Correction of
- Rounding rules
- Back dating
- Missing data
- Voiding /
- Recreating / rewriting records
- General Tips for
Laboratory Notebook Documentation:
- Assignment of Lab
- How to properly
document in lab notebooks
- How to include
tables / graphs
- How to attach
instrument print outs
- How to include
- How to reference
- How to store the
completed lab notebooks
- US Pharmacopoeia
General Chapter <1029>
- Rules Governing
Medicinal Products in the European Union (Vol. 4: Documentation)
- What is new in the
- Outline of EU GDP
- GDP Enforcement
(examples from FDA warning letters)
Who Can Benefit From This Course:
- Anybody who works
in a regulated environment
& Production Personnel / Managers
- Research and
Development Personnel (R&D) / Managers
- Quality Assurance
& Quality Control Personnel / Managers
Personnel / Managers
- Clinical trial
- Project Managers
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 development, clinical trials, Medical and regulatory writing and intellectual property. She is currently the Vice President of Medical Affairs at Easy Global Training, which is a US-based firm providing global regulatory, quality and medical affairs training backed by consulting. Before joining this company, Dr. Motamed Khorasani has served as an independent consultant, director of medical affairs, senior medical sciences liaison, senior scientist and senior medical analyst at Merck (MDS), Johnson & Johnson, United States Pharmacopeia Convention (USP), Amgen, Baxter International, Covidien (eV3), Radient Pharmaceuticals, AMDL Diagnostics, Microbix Biosystems, Neometrix Consulting, Mount Sinai Hospital, Princess Margaret Hospital, and Vancouver General Hospital.
She has more than 20 years of experience and many National and international certificates in GLP, GMP, ICH-GCP and global regulatory compliance for clinical trials and is a member in a number of professional associations, including: American Association of Cancer Research (AACR), American Medical Writers Association (AMWA), Regulatory Affairs Professional Society (RAPS), American Society of Quality (ASQ), Project Management Institute (PMI), and Intellectual Property Institute of Canada (IPIC). Dr. Motamed Khorasani's research has focused on high throughput approaches in the context of cancer informatics with a particular interest in the use of comparative analysis for the mining of integrated oncology datasets that include protein-protein interaction and gene expression profiling. She has published and presented more than 50 papers, abstracts and articles in highly regarded scientific journals and high profile conferences and scientific meetings.