Dr. Afsaneh Motamed Khorasani 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.
Laboratory notebook documentation is a part that is covered under Good documentation Practices (GDP), an essential regulation that needs to be closely followed by the personnel in any regulated environment. GDP describes standards and Best Practices on how to create, maintain, and archive documents to remain compliant. It is a part of Current Good Manufacturing Practices (cGMP) and regulatory bodies inspect against the GDP guidelines. If companies are not following the GDP guidelines, they may get comments, observations, 483s, and penalties from the relevant regulatory body in charge.
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.
This e-Book “Laboratory Notebook Documentation” covers the essentials of GDP, its definition, purpose, and importance. Then expands on general rules and principles of GDP in Laboratory Notebook documentation with real-life examples to help you grasp the concepts discussed.
In this “Laboratory Notebook Documentation” e-Book, you learn about:
- Definition, purpose, and importance of GDP
- General rules of GDP and Best Practice in Laboratory Notebook Documentation with examples:
- Assignment of lab notebook
- Using Table of Content (TOC)
- How to write in a laboratory notebook
- Entering date and time; and back-dating
- Rounding rules, signature, and initial
- How to correct errors
- How to separate experiments
- How to include tables, graphs, print outs
- How to store metadata
Who Can Benefit From This Laboratory Notebook Documentation e-Book
- Anybody who works in a regulated environment
- Manufacturing & Production Personnel / Managers
- Research and Development Personnel (R&D) / Managers
- Laboratory Personnel / Managers
- Validation Specialists
- Clinical trial personnel
- QA / QC Managers, specialists, and auditors
- Chemists / pharmacists
- Employers in pharmaceutical & medical device industry
- ID: 1902
- SKU: EB-0007-BP
- Type: e-Book
- Format: Downloadable PDF File (.pdf)
- Date of Last Update: Aug 30, 2018
- Length: 36 Pages
- Course Level: Moderate/Advance
- Price: $40.00
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