This message is sent to you by FDA Newswatch

Good Documentation Practice and Record Keeping Regulations (FDA & EMA)

Wednesday January 13, 2021 08:00 AM PST | 11:00 AM EST 60 Min

Sponsored by ComplianceOnline

Click Here to register $229.00

Click Here to register $499.00
In this webinar, we will discuss the definition, purpose, importance of GDP, General rules of GDP, GDP as it applies to laboratory notebook documentation, US Pharmacopeia General Chapter <1029>, and introduction “Good Documentation Guidelines”. We will also briefly introduce you to the European Union (EU) GDP, and its enforcement along with some observation samples from FDA.

 

Why Should You Attend:

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 60-min Webinar covers the essentials of GDP, its definition, purpose, and importance. Then expands on general rules and principles of GDP (US & EU), General tips for Laboratory Notebook documentation and finally discussing GDP enforcement by regulatory bodies in different countries with some examples of FDA citations.

If you are involved in any product manufacturing, knowing GDP regulations is a must for you. It prevents a lot of errors and minimizes the chance of being spotted by the regulatory bodies in their audits.

The outline of this training 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
      • Back dating
      • Missing data
      • Voiding / cancelling records
      • Recreating / rewriting records
      • Deviations
  • Rules Governing Medicinal Products in the European Union (Vol. 4: Documentation)
    • What is new in the Latest Version?
  • GDP Enforcement (examples from FDA warning letters)

Instructor Profile:

    Dr. Afsaneh Motamed Khorasani
    Vice President of Medical Affairs, Easy Global Training

    Dr. Afsaneh Motamed Khorasani, PhD, 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 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.