Laboratory Notebook Documentation (GDP)

$100.00

ID:          1902
SKU:      EB-0007-BP
Type:     e-Book

This comprehensive 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.


Description

Author’s Bio:

dr afsaneh motamed khorasani

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
Laboratory notebook documentation is a part covered under Good documentation Practices (GDP), an essential regulation that the personnel must closely follow in any regulated environment. Also, GDP describes standards and Best Practices for creating, maintaining, and archiving documents to remain compliant. Moreover, it is a part of Current Good Manufacturing Practices (cGMP), and regulatory bodies inspect against the GDP guidelines. Therefore, if companies are not following the GDP guidelines, they may get comments, observations, 483s, and penalties from the relevant regulatory body in charge.

Knowing GDP regulations is a must if you are involved in any product manufacturing. It prevents many 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. Also, it expands on general rules and principles of GDP in Laboratory Notebook documentation with real-life examples to help you grasp the concepts discussed.

Learning Highlights
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
    • The proper way to separate experiments
    • The correct way of including tables, graphs, printouts
    • 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 the pharmaceutical & medical device industry
Details
  • 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:                              $100.00
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