If there is one element that one can consider the very soul of most regulated industries, it has to be Good Documentation Practices. Adherence to GDP principles is nonnegotiable for agencies such as the FDA, the EMA, or for that matter, any other regulatory agency around the world.
The cornerstone of GDP is the principle of evidence. The FDA or any other regulatory agency around the world considers this the essential basis for GDP. Evidence is so crucial that what is not documented does not exist, according to these agencies.
So, in the context of the regulated industries, what is to be written down, how and in what form? All these and more will be the learning this online professional training course will impart. The speaker, Dr. Afsaneh Motamed Khorasani, is a PhD who brings enormous experience in medical and scientific affairs. The main intention of this webinar is to help participants get a clear understanding of the GDP regulations that apply to their area of work. With this learning, they will be able to prevent any errors that could creep in into their GDP and overcome lacunae that the FDA could catch during its audits.
At this online regulatory compliance training, Dr. Khorasani will offer insights into the core areas of GDP, such as definition, purpose, importance of GDP, general rules of GDP, GDP as it applies to laboratory notebook documentation, US Pharmacopeia General Chapter 1029, which deals with GDP, and an introduction to Good Documentation Guidelines. She will also briefly touch upon the European Union (EU) GDP and explain how it needs to be enforced. She will also explain GDP as the FDA sees it, by using some observation samples from the FDA.
This online regulatory compliance training, which is of immense value to 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 and Project Managers, will cover the full range of issues relating to GDP.
Dr. Khorasani will cover the following areas at this 60-minute training course for professionals:
o Definition, Purpose, and Importance
o General Rules and Principles of GDP
o Requirements of Records
o General Tips in GDP:
o Signature/initial and the meaning
o Copying records
o Document maintenance
o Recording the time and date
o Correction of errors
o Rounding rules
o Back dating
o Missing data
o Voiding/cancelling records
o Recreating/rewriting records
o Deviations
o Rules Governing Medicinal Products in the European Union (Vol. 4: Documentation)
o What is new in the Latest Version?
o GDP Enforcement (examples from FDA warning letters).

Author's Bio: 

Dr. Afsaneh Motamed Khorasani, PhD, is 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.