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

  • Speaker:Dr. Afsaneh Motamed Khorasani, PhD
  • Duration:90Min
  • Product Code:GRC-90388

Live Session - How it works

  • Username and Password will be sent to you within 24 hours prior to the webinar.
  • Presentation handouts in pdf format will be emailed to along with the login instructions or few hours before the meeting starts.
  • Login to the session by clicking on “Join the Meeting” in the login instructions and then dial the number to connect to the meeting audio or use your Computer to connect to audio. Please use the name and the email address you used at the time of registration to join the meeting.
  • Get answer to your queries through interactive Q&A sessions. The Q and A sessions are at the end of the meeting. The expert will complete his/ her presentation and then the phone lines will be open for the audience to discuss your questions.
  • Please let us know your thoughts and views at the end of webinar, your valuable feedback will help us improve our Training programs.
  • Certificate of attendance is emailed to you within 6 working days from the date the webinar was completed. If you don’t receive an email within 6 days. Please email our support@grcts.com

Recorded Session - How it works

  • Login Information with Password to view the webinar will be emailed to you within 48 hours from the date the Live webinar was completed. The link to the recording is for a single person use only and it is valid for 6 months or the actual duration the recording was purchased.
  • Please click on the link to access the Recording and type in the password provided in the email.
  • Presentation and other handouts will be emailed to you in a pdf format.

Training CD - How it works

  • Free shipment within 2 working days, from the date the webinar was completed. The presentation and other handouts will be emailed to you in a pdf format if we are unable to attach them in the CD or USB.

(For more information about our products contact +1- 248-233-2049)

If you are unable to attend the meeting Live then you can opt in for the Live Recording instead. Access the recording of the webinar for 6 months. Contact our support for any questions. To prepare an invoice to pay by Check or Wire email us at support@grcts.com. 

Certifications: GRCTS Attendance Certificate -

Background:

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.

Why you must attend: 

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.

Areas Covered in the Webinar Session:

Following the completion of this On-Demand Webinar you will gain a basic to moderate knowledge of definition, purpose, importance of GDP, General rules of GDP, GDP as applies to laboratory notebook documentation, US Pharmacopeia 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.

  • 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
  • General Tips for Laboratory Notebook Documentation:
  • Assignment of Lab notebook
  • How to properly document in lab notebooks
  • How to include tables / graphs
  • How to attach instrument print outs
  • How to include metadata
  • How to reference lab notebook
  • How to 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 (examples from FDA warning letters)

 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

Instructor Profile:         

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.

She has more than 20 years of experience and many National and international certificates in GLP, GMP, ICH-GCP and global regulatory compliance for clinical trials and is a member in a number of professional associations, including: 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). Dr. Motamed Khorasani's research has focused on high throughput approaches in the context of cancer informatics with a particular interest in the use of comparative analysis for the mining of integrated oncology datasets that include protein-protein interaction and gene expression profiling.

She has published and presented more than 50 papers, abstracts and articles in highly regarded scientific journals and high profile conferences and scientific meetings.

Available Options

Recording: 6 Months Access to the Training which can be accessed from any location

$259

Recording Access to 8 Members: 6 months access to 8 participants. Recording can be accessed from any location

$759

CD-DVD: Shipped within 2 working days

$389

USB - Shipped within 2 working days

$429

5 Member Group: 5 people can Attend the Live Online Meeting from any location globally

$2,879

10 Member Group: 10 people can Attend the Live Online Meeting from any location globally

$4,759

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