Good Documentation Practices Webinar (General)

Description

Speaker’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).

Her research has focused on high throughput approaches in 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.

On-Demand Good Documentation Practices Webinar Overview
This Good Documentation Practices Webinar is designed to provide an overview of the essential principles of Good documentation practices (GDP). Generally, Good Documentation Practices are a critical factor. Therefore, it must be closely followed by the personnel in any regulated environment as a process for successful project completion, including observations of unanticipated responses that are required to be accurately recorded and verified.

This 100-minute On-Demand, Good Documentation Practices Webinar, covers the essentials of GDP, its definition, purpose, and importance. Also, it expands on general rules and principles of GDP (US & EU), General tips for Laboratory Notebook documentation. Finally, it discusses GDP enforcement by regulatory bodies in different countries with some examples of FDA citations.

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

Learning Highlights

• Following the completion of this 100-minute On-Demand Good Documentation Practices Webinar, you will gain an essential to moderate knowledge of definition, purpose, the importance of GDP, General rules of GDP, GDP as applied to laboratory notebook documentation, US Pharmacopoeia General Chapter <1029> introduction “Good Documentation Guidelines,” A very brief introduction to European Union (EU) GDP, and finally its enforcement along with some observation samples from FDA.
• The outline of this 100-minute On-Demand Webinar includes:
  • Definition, Purpose, and Importance
  • General Rules and Principles of GDP
    • Requirements of Records
    • General Tips in GDP:
      • Signature / initial and the meaning
      • Copying records
      • Document maintenance
      • Recording the time and date
      • Correction of errors
      • Rounding rules
      • Backdating
      • Missing data
      • Voiding / canceling records
      • Recreating/rewriting records
      • Deviations
    • General Tips for Laboratory Notebook Documentation:
      • Assignment of Lab notebook
      • How to properly document in lab notebooks
      • The correct way to include tables/graphs
      • How to attach instrument printouts
      • The proper way of including metadata
      • How to reference lab notebook
      • The way you can store the completed lab notebooks
  • US Pharmacopoeia General Chapter <1029>
  • Rules Governing Medicinal Products in the European Union (Vol. 4: Documentation)
    • What is new in the Latest Version?
    • Outline of EU GDP Regulations
  • GDP Enforcement
  • Summary
  • References

Who Can Benefit From This Good Documentation Practices 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

Details

• ID:                                     1326
• SKU:                                 OW-0002-BP
• Type:                                On-Demand Webinar
• Format:                            Video MP4 Play Back
• Date of Last Update:    Jan 05, 2017
• Duration:                         100 minutes
• Course Level:                 Intermediate/Advance
• Price:                               $249.00

Notes

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