Good Documentation & Record Keeping Best Practices (Drugs & Devices)

$249.00

ID:          1329
SKU:      OW-0004-BP
Type:     On-Demand Webinar

 

Following the completion of this 90-minute On-Demand Webinar, you will gain advanced knowledge of the definition, purpose, the importance of GDP, General rules of controlled documentation / GDP, and GDP as applies to drugs and devices (21 CFR 212, 21 CFR 211, 21 CFR 312, and 21 CFR 312), and finally GDP enforcement with examples of FDA observations.


SKU: OW-0004-BP

Categories: ,

Description

Good Documentation & Record Keeping Best Practices

Speaker’s Bio:

dr afsaneh motamed khorasani

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 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 that the personnel must closely follow in any regulated environment for successful project completion. This includes observations of unanticipated responses that must be accurately recorded and verified. This 90-minute On-Demand Webinar covers the essentials of GDP, its definition, purpose, and importance. Also, it expands on general rules and principles of GDP (US & EU), document, and record keeping best practices specifically as it applies to drugs and devices (21 CFR Parts 212, 211, 312, and 812). Finally, there will be a discussion on DDP enforcement by different regulatory bodies and examples of FDA observations.

Learning Highlights
  • Following the completion of this 90-minute On-Demand Webinar, you will gain advanced knowledge of the definition, purpose, the importance of GDP, General rules of controlled documentation / GDP, and GDP as applies to drugs and devices (21 CFR 212, 21 CFR 211, 21 CFR 312, and 21 CFR 312), and finally GDP enforcement with examples of FDA observations.
  • The outline of this 90-minute On-Demand Webinar includes:
    • Definition, Purpose, and Importance
    • General Rules and Principles of controlled documentation:
      • Requirements of Records
      • General Tips in GDP
    • Document & Record Keeping Best Practices (Drugs & Devices):
      •  Pharmaceuticals (Drugs):
        • Part 211: finished pharmaceutical products
        • Part 312: Investigational new drug application (INDA)
        • Part 212: Positron Emission Tomography Drugs
      • Devices:
        • Part 812: Investigational Device Exemption (IDE)
    • GDP Enforcement
    • Summary
    • References
Who Can Benefit From This Course
  • 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:                                     1329
  • SKU:                                 OW-0004-BP
  • Type:                                On-Demand Webinar
  • Format:                            Video MP4 Play Back
  • Date of Last Update:    Jan 15, 2017
  • Duration:                         90 minutes
  • Course Level:                 Intermediate / Advanced
  • Price:                               $249.00
Notes
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