Source: https://www.easyglobaltraining.com/product/gdp-for-nonclinical-laboratory-studies-21-cfr-part-58/
Timestamp: 2019-11-19 08:32:08
Document Index: 83430243

Matched Legal Cases: ['art 58', 'art 58', 'art 58', 'art 58', 'art 58', 'art 58']

GDP for Nonclinical Laboratory Studies (21 CFR Part 58) | Easy Global Training
Tags: GDP, Good Documentation Practices, e-Book, course, online course, online training, quality compliance, Easy Global training, non-clinical studies, pre-clinical studies, nonclinical studies, 21 CFR part 58, Afsaneh Motamed
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.
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.
Good documentation Practices (GDP) is 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 in order to maintain compliance. It is a part of Current Good Manufacturing Practices (cGMP) and regulatory bodies inspect for the compliance with the GDP guidelines. If companies are not following the GDP guidelines, they may get different levels of disciplinary actions.
If you are involved in any non-clinical studies, 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 covers the essentials of GDP, its definition, purpose, and importance. Then expands on records attributes as well as the general rules and principles of GDP in non-clinical laboratory study documentation. 21 CFR Part 58 covers the GMP (including GDP) regulations for non-clinical laboratory studies.
In this “GDP for Nonclinical Laboratory Studies (21 CFR Part 58)” e-Book, you learn about
Definition, application, purpose, and importance of GDP
Records attributes
21 CFR Part 58:
Maintenance & calibration of equipment
Storage & retrieval of records & data
Who Can Benefit From This “GDP for Nonclinical Laboratory Studies (21 CFR Part 58)” e-Book
Personnel involved in non-clinical laboratory studies
QA / QC Managers and specialists
Date of Last Update: Sep 02, 2018