GDP for Medicinal Products in the European Union

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. It needs to 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), and regulatory bodies inspect for compliance with the GDP guidelines. Therefore, if companies are not following the GDP guidelines, they may get different levels of disciplinary action.

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 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 guides 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 the 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 the pharmaceutical & medical device industry

Details

• 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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