Good Documentation Practices & Good Record Keeping


ID:          1896
SKU:      EB-0005-BP
Type:     e-Book

In this comprehensive e-Book (Good Documentation Practices), the essentials of GDP, its definition, purpose, and importance are explored first, followed by expanding on general rules and principles of GDP (ISO, ICH, FDA, EMA, USP), general tips for Laboratory Notebook documentation, and GDP enforcement by regulatory bodies in different countries with some examples of FDA citations and observations.


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.

Good documentation Practices (GDP) is an essential regulation that needs to be closely followed by the personnel in any regulated environment. Good Documentation Practices 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 Good Documentation Practices 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 Good documentation Practices 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 Good Documentation Practices, its definition, purpose, and importance. Then expands on general rules and principles of Good Documentation Practices (ISO, ICH, FDA, EMA, USP), General tips for Laboratory Notebook documentation, and Good Documentation Practices enforcement by regulatory bodies in different countries with some examples of FDA citations and observations.

Learning Highlights
In this Good Documentation Practices e-Book, you learn about:

  • Definition, purpose, and importance of GDP
  • General rules of GDP (ISO, ICH, FDA), including: record requirements, signature, deviations, rounding rules, back dating, and missing data)
  • Copying, correction, voiding, and recreating records
  • GDP in laboratory notebook documentation
  • US Pharmacopeia Chapter <1029>
  • European Medicine Agency (EMA) view of GDP
  • GDP enforcement (examples of FDA observations)
Who Can Benefit From This Good Documentation Practices 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
  • Chemists / pharmacists
  • Employers in pharmaceutical & medical device industry
  • Company management
  • Auditors
  • ID:                                    1896
  • SKU:                                EB-0005-BP
  • Type:                               e-Book
  • Format:                          Downloadable PDF File (.pdf)
  • Date of Last Update:   Aug 10, 2018
  • Length:                           64 Pages
  • Course Level:                Moderate/Advance
  • Price:                              $100.00
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