GDP for Medicinal Products in the European Union


ID:          1903
SKU:      EB-0008-BP
Type:     e-Book

This comprehensive e-Book “GDP for Medicinal Products in the European Union” covers the general rules and principles of GDP based on EudraLex “The rules governing medicinal products in the European Union (EU).” In the volume 4 of this document titled “Good Manufacturing Practice – Medicinal Products for Human and Veterinary Use”, Chapter 4 is titled “documentation”.


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. 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.

This e-Book covers the general rules and principles of GDP based on EudraLex “The rules governing medicinal products in the European Union (EU).” In the volume 4 of this document titled “Good Manufacturing Practice – Medicinal Products for Human and Veterinary Use”, Chapter 4 is titled “documentation”. Article 47 of Directive 2001/83/EC on the Community code relating to medicinal products for human use provides guidance for the interpretation of the principles and guidelines of good manufacturing practice (GMP) for medicinal products as laid down in Directive 2003/94/EC for medicinal products for human use in the EU.

Learning Highlights
In this “GDP for Medicinal Products in the European Union” e-Book, you learn about:

  • Definition, application, purpose, and importance of GDP
  • Principle of GDP in EU
  • Required GMP documentation in the EU (site master file, instructions, records / reports)
  • Generation and control of documentation in the EU
  • Good documentation practices in the EU
  • Retention of documents in the EU
  • Specifications in the EU (specifications for intermediate and bulk products, specifications for finished products)
  • Manufacturing Formula & processing instructions in the EU (packaging instructions, batch processing records, batch packaging records)
  • Procedures and records (Receipt, sampling, testing, other)
Who Can Benefit From This “GDP for Medicinal Products in the European Union”  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 pharmaceutical & medical device industry
  • ID:                                    1903
  • SKU:                                EB-0008-BP
  • Type:                               e-Book
  • Format:                          Downloadable PDF File (.pdf)
  • Date of Last Update:   Sep 01, 2018
  • Length:                           31 Pages
  • Course Level:                Moderate/Advance
  • Price:                              $100.00
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