Good Documentation Practice and Record Keeping Regulations (FDA & EMA)
Instructor:
Dr. Afsaneh Motamed Khorasani
Product ID: 705583
Training Level: Intermediate
- 12
- December 2024
Thursday - 08:00 AM PT | 11:00 AM ET
Duration: 60 Min
Why Should You 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:
Following the completion of this 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.
The outline of this 60 minute Webinar 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)
Who Will Benefit:
This webinar is applicable to the Medical Device and Pharmaceutical industries. Titles includes:
- 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
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 AztraZeneca (AZ), Insmed, Merck (MDS), Johnson & Johnson, United States Pharmacopeia Convention (USP), Amgen, Baxter International, MedTronic, AMDL Diagnostics, Microbix Biosystems, 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), and Project Management Institute (PMI). 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 is a well-published author with books, book chapters, e-books, online scientific articles, and has published and presented more than 50 papers, abstracts and articles in highly regarded scientific journals and high profile conferences and scientific meetings.
Refund Policy
Our refund policy is governed by individual products and services refund policy mentioned against each of offerings. However in absence of specific refund policy of an offering below refund policy will be effective.
Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange. Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time. On-Demand Recording purchases will not be refunded as it is available for immediate streaming. However if you are not able to view the webinar or you have any concern about the content of the webinar please contact us at below email or by call mentioning your feedback for resolution of the matter. We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email [email protected] call +1-888-717-2436 (Toll Free).
