Good Documentation Guidelines (USP <1029>) Webinar


ID:          778
SKU:      OW-0001-BP
Type:     On-Demand Webinar


This 60 minute On-Demand Good Documentation Guidelines (USP <1029>) Webinar will  familiarize you with the US Pharmacopoeia General Chapter <1029> in Good Documentation Guidelines, which adds some high level information to all other Good documentation rules and regulations out there.This USP Chapter wraps up the general concept and provides the information as to what needs to be documented in certain records.

SKU: OW-0001-BP

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Speaker 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 Pharmacopoeia 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 data sets 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.

On-Demand Webinar Overview
Good documentation Practices (GDP) is an essential factor that needs to be closely followed by the personnel in any regulated environment as a process for a successful project completion including observations of unanticipated responses that are required to be accurately recorded and verified.

This 1-hour On-Demand Good Documentation Guidelines (USP <1029>) Webinar covers the newly published USP General Chapter <1029> “Good Documentation Guidelines”.

To view a 5 minute Teaser of this online webinar Click Here.

Learning Highlights
  • After this 60 minute Good Documentation Guidelines (USP <1029>) Webinar, you will become familiar with the USP General Chapter <1029> in Good Documentation Guidelines which adds some high level information to all other Good documentation rules and regulations out there.
  • This will wrap up the general concept and will provide the information as to what needs to be documented in certain records.
  • The outline of the discussion includes:
    • History of the chapter as to 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 Good Documentation Guidelines (USP <1029>) Webinar
  • Anybody who works in a regulated environment
  • Manufacturing & Production Personnel / Managers
  • Research and Development Personnel (R&D) / Managers
  • Quality Assurance & Quality Control Personnel / Managers
  • Laboratory Personnel / Managers
  • Validation Specialists
  • Clinical trial personnel
  • Project Managers
  • ID:                                     778
  • SKU:                                 OW-0001-BP
  • Type:                                On-Demand Webinar
  • Format:                            Video MP4 Play Back
  • Date of Last Update:    Jan 15, 2017
  • Duration:                         60 minutes
  • Course Level:                 Intermediate
  • Price:                               $250.00
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