USP Chapter Good Documentation Guidelines

Description

Author’s 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, a US-based firm providing global regulatory, quality, and medical affairs training backed by consulting.

Before joining this company, Dr. Motamed Khorasani 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. Also, she has many National and international certificates in Good Laboratory Practice (GLP), Good Manufacturing Practice (GMP), ICH-Good Clinical Practice (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).

Also, her research has focused on high throughput approaches in the context of cancer informatics with a particular interest 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

USP Chapter 1029 (Good Documentation Guideline) is a general Chapter in US Pharmacopeia. Additionally, it covers all aspects of Good Documentation Practices (GDP). GDP is a critical and essential part of a regulated environment (pharmaceutical and medical device manufacturing, R&D, laboratories, and clinical trials). Also, compliance with GDP ensures an auditable account of work. Furthermore, it ensures integrity and control of documents. Finally, it is a crucial requirement for a developed quality system.

Knowing GDP regulations is a must if you are involved in product manufacturing. Also, it prevents many errors and minimizes the chance of being spotted by the regulatory bodies in their audits.

This e-Book covers the US Pharmacopeia General Chapter <1029> (USP Chapter 1029). Also, it discusses all aspects of GDP, including writing and correcting documentation practices. Generally, it explains the general concept and provides information on what needs to be documented in certain records.

Learning Highlights

In this USP Chapter 1029 e-Book, you learn about:

• History of USP chapter <1029> (how and why it was created)
• Purpose of development of this chapter
• Chapter outline:
  • Principles of Good Documentation
  • Data collection & recording
  • Different types of GMP Documents:
    • Laboratory records
    • Equipment-related documentation
    • Deviations and investigations
    • Batch records
    • Certificate of Analysis (C of A)*
    • Standard Operating Procedure (SOP)*
    • Protocols & reports*
    • Analytical procedures*
    • Training documentation
  • And retention of documents

Who Can Benefit From This USP Chapter <1029> e-Book

• Anybody who works in a regulated environment
• Manufacturing & Production Personnel / Managers
• Research and Development Personnel (R&D) / Managers
• Laboratory Personnel / Managers
• Chemists / pharmacists & validation Specialists
• Clinical trial personnel
• QA / QC Managers, specialists, and auditors
• Employers in the pharmaceutical & medical device industry

Details

• ID:                                    1898
• SKU:                                EB-0005-BP
• Type:                               e-Book
• Format:                          Downloadable PDF File (.pdf)
• Date of Last Update:   Aug 10, 2018
• Length:                           37 Pages
• Course Level:                Moderate/Advanced
• Price:                              $100.00

Notes

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