BEGIN:VCALENDAR VERSION:2.0 PRODID:icalendar-ruby CALSCALE:GREGORIAN BEGIN:VEVENT DTSTAMP:20240328T123342Z UID:a4c95ad5-fa5f-44ce-a92e-246ec147154d DTSTART:20210504T083000 DTEND:20210505T083000 CLASS:PRIVATE DESCRIPTION:
Good documentation Practices (GDP) is an essen tial factor that needs to be closely followed by the personnel in any regu lated environment as a process for a successful project completion includi ng observations of unanticipated responses that are required to be accurat ely recorded and verified. This one-day workshop covers the essentials of GDP\, its definition\, purpose\, and importance. Then expands on general r ules and principles of GDP (US &\; EU)\, General tips for Laboratory No tebook documentation and finally discussing GDP enforcement by regulatory bodies in different countries with some examples of FDA citations and warn ing letters for different points presented in the session. In several occa sions\, group activities will be presented to find errors in documents bas ed on the information provided in the class.
\n\nIn this seminar you will gain a basic to moderate knowledge of definition\, purpose\, importance of GDP\, General rules of GDP\, GDP a s applies to laboratory notebook documentation\, US Pharmacopeia General C hapter introduction "\;Good Documentation Guidelines"\;\, A very b rief introduction to European Union (EU) GDP\, and finally its enforcement along with some observation samples from FDA.
\n\n \;
\n\nDr. Afsaneh Motamed K
horasani
\nVice President of Medical Affairs\, Easy Global Training
p>\n\n
Dr. Afsaneh Motamed Khorasani\, PhD\, is a Medical and scientific Affairs expert and a Senior Scientist with a strong background in biomedi cal science and clinical trial/research. She has a tenured and diverse ran ge of experience in medical affairs\, basic and industrial clinical resear ch and development\, clinical trials\, Medical and regulatory writing and intellectual property. She is currently the Vice President of Medical Affa irs at Easy Global Training\, which is a US-based firm providing global re gulatory\, quality and medical affairs training backed by consulting. Befo re joining this company\, Dr. Motamed Khorasani has served as an independe nt consultant\, director of medical affairs\, senior medical sciences liai son\, senior scientist and senior medical analyst at Merck (MDS)\, Johnson &\; Johnson\, United States Pharmacopeia Convention (USP)\, Amgen\, Ba xter International\, Covidien (eV3)\, Radient Pharmaceuticals\, AMDL Diagn ostics\, Microbix Biosystems\, Neometrix Consulting\, Mount Sinai Hospital \, Princess Margaret Hospital\, and Vancouver General Hospital.
\n\nShe has more than 20 years of experience and many National and internation al certificates in GLP\, GMP\, ICH-GCP and global regulatory compliance fo r clinical trials and is a member in a number of professional associations \, including: American Association of Cancer Research (AACR)\, American Me dical 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 th e context of cancer informatics with a particular interest in the use of c omparative analysis for the mining of integrated oncology datasets that in clude protein-protein interaction and gene expression profiling. She has p ublished and presented more than 50 papers\, abstracts and articles in hig hly regarded scientific journals and high profile conferences and scientif ic meetings.
\n\nPlease contact the event manager Marilyn (marilyn.b
.turner(at)nyeventslist.com ) below for: \;
\n- Multiple particip
ant discounts \;
\n- Price quotations or visa invitation letters&
nbsp\;
\n- Payment by alternate channels (PayPal\, check\, Western Un
ion\, wire transfers etc) \;
\n- Event sponsorship \;
\n
\nNO REFUNDS ALLOWED ON REGISTRATIONS \;
\nPrices may go up
any time. Service fees included in pricing. \;
\n---------------
-------------------------------------------------- \;
\nThis even
t is brought to you by: \;
\nMetricStream\, Inc. - NewYorkEventsL
ist \;
\nhttp://www.NyEventsList.com \;
\nhttp://www.Bos
tonEventsList.com \;
\nhttp://www.SFBayEventsList.com \;
\n-----------------------------------------------------------------
VIO180109CEV
\n SUMMARY:Good Documentation Practice and Record Keeping Regulations (FDA & E MA) BEGIN:VALARM ACTION:DISPLAY TRIGGER:-PT1H SUMMARY:Good Documentation Practice and Record Keeping Regulations (FDA & E MA) END:VALARM END:VEVENT END:VCALENDAR