Good Documentation Practices and Recordkeeping Regulations (FDA & EMA)

Event Information
Product Format
Prerecorded Event
Conference Date
Wed, Feb 21, 2018
90 minutes
Product Description

Get Tips for Good Documentation Practices that Will Please FDA & EMA Auditors

If you are involved in any kind of regulated product manufacturing, knowledge of good documentation practices (GDP) is a must. Otherwise, you risk making costly errors and catching the unwanted attention of regulatory bodies, such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).

Join this session with expert speaker Dr. Afsaneh Motamed Khorasani for a basic- to intermediate-level discussion of the definition, purpose, and importance of GDP. In particular, Afsaneh will discuss GDP rules as they apply to laboratory notebook documentation. She will cover the U.S. Pharmacopeia General Chapter “Good Documentation Guidelines”. Further, she will provide an introduction to European Union (EU) GDP and its enforcement, along with some observation samples from the FDA.

Session Highlights

This session will cover:

  • GDP definition, purpose, and importance
  • GDP rules and requirements, including instruction on the following elements:
    • Record copying
    • Error correction
    • Rounding rules
    • Signature/initial
    • Missing data
    • Time/date recording and back-dating
    • Record maintenance
    • Record voiding/cancellation and recreating/rewriting
    • Lab notebook documentation (e.g., how to include tables/graphs, use metadata, attach instrument printouts, and reference a lab notebook).
    • Completed lab notebook storage
  • US Pharmacopeia general chapter
  • 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

Who Should Attend

  • Professionals working in a regulated environment
  • Manufacturing and production personnel/managers
  • Research and development personnel (R&D)/managers
  • Quality assurance and quality control personnel/managers
  • Laboratory personnel/managers
  • Validation specialists
  • Clinical trial personnel
  • Project managers

Ask a question at the Q&A session following the live event and get advice unique to your situation, directly from our expert speaker.

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About Our Speaker

Dr. Afsaneh Motamed Khorasani

Dr. Afsaneh Motamed Khorasani, Ph.D., is a medical and scientific affairs expert, and a senior scientist with a strong background in biomedical science and clinical trial/research. Afsaneh 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...   More Info
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