Good Documentation Guidelines (USP <1029>) Webinar

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 Webinar Overview
Good documentation Practices (GDP) are an essential factor. So, the personnel must follow them in any regulated environment for successful project completion, including observations of unanticipated responses that must 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. Also, this will add high-level information to all other Good documentation rules and regulations.
• This will wrap up the general concept and provide information on 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 guideline (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

Details

• 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

Notes

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