GDP for Nonclinical Laboratory Studies (21 CFR Part 58)

$20.00

ID:          1905
SKU:      EB-0009-BP
Type:     e-Book

This comprehensive e-Book “GDP for Nonclinical Laboratory Studies (21 CFR Part 58)” 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.


Description

Authors’ Bio:

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.

Overview
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.

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:                              $20.00
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