GDP for Nonclinical Laboratory Studies (21 CFR Part 58)

Description

Author’s Bio:

Dr. Afsaneh Motamed Khorasani is a Medical and scientific Affairs expert and a Senior Scientist. Moreover, she has a strong background in biomedical science and clinical trial/research. Also, 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. Furthermore, she is the Vice President of Medical Affairs at Easy Global Training, a US-based firm providing global regulatory, quality, and medical affairs training backed by consulting.

Formerly, she served as an independent consultant, director of medical affairs, senior medical sciences liaison, senior scientist, and senior medical analyst at many different companies. Also, she has worked with AstraZeneca, 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. Also, she has many National and international certificates in GLP, GMP, ICH-GCP, and global regulatory compliance for clinical trials. Furthermore, she is a member of several professional associations, including the 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. Moreover, her particular interest was in using comparative analysis for mining integrated oncology datasets that include protein-protein interaction and gene expression profiling. Furthermore, she has published and presented more than 50 papers, abstracts, and articles in highly regarded scientific journals, high-profile conferences, and scientific meetings.

Overview
Good documentation Practices (GDP) is an essential regulation. Therefore, it must be closely followed by the personnel in any regulated environment. Moreover, GDP describes standards and Best Practices for creating, maintaining, and archiving documents to maintain compliance. Also, it is a part of Current Good Manufacturing Practices (cGMP). So, regulatory bodies inspect for compliance with the GDP guidelines. If companies are not following the GDP guidelines, they may get different levels of disciplinary action.

Knowing GDP regulations is a must if you are involved in non-clinical studies. Moreover, it prevents many 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. Also, it expands on records attributes and 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.

Learning Highlights
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:
  • Study director
  • Maintenance & calibration of equipment
  • Conduct of the study
  • Reporting the results
  • Storage & retrieval of records & data
  • Retention of records

Who Can Benefit From This “GDP for Nonclinical Laboratory Studies (21 CFR Part 58)”  e-Book

• Anybody who works in a regulated environment
• Manufacturing & Production Personnel / Managers
• Personnel involved in non-clinical laboratory studies
• Research and Development Personnel (R&D) / Managers
• Laboratory Personnel
• Validation Specialists
• QA / QC Managers and specialists
• Auditors
• Chemists / pharmacists

Details

• ID:                                    1905
• SKU:                                EB-0009-BP
• Type:                               e-Book
• Format:                          Downloadable PDF File (.pdf)
• Date of Last Update:   Sep 02, 2018
• Length:                           24 Pages
• Course Level:                Moderate/Advance
• Price:                              $100.00

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