USP Chapter <1029>Good Documentation Guidelines

$100.00

ID:          1898
SKU:      EB-0006-BP
Type:     e-Book

In this comprehensive e-Book (USP Chapter <1029>), the US Pharmacopeia General Chapter <1029> and all aspects of GDP, including practices for writing and correcting documentation, is explained. It expands on the general concept and provides information about what needs to be documented in certain records.


Description

Overview

USP Chapter 1029 (Good Documentation Guideline) is a general chapter in US Pharmacopeia that 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). Compliance with GDP ensures an auditable account of work. It ensures integrity and control of documents and is a key requirement for a developed quality system.

If you are involved in any product manufacturing, knowing GDP regulations is a must for you. 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) and all aspects of GDP including practices for writing and correcting documentation. It will explain the general concept and provide 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
    • 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
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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, 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 Good Laboratory Practice (GLP), Good Manufacturing Practice (GMP), ICH-Good Clinical Practice (GCP), and global regulatory compliance for clinical trials and is a member of several 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.