Online Safety Community

Webinar from Traininng.com about Good Documentation and Record Keeping Best Practices (FDA & EMA) on January 24

Fremont, CA: Traininng.com, a reputable provider of training courses for professionals for all the areas of regulatory compliance, is organizing a webinar on the topic, “Good Documentation and Record Keeping Best Practices (FDA & EMA)” on January 24, 2019. The speaker at this webinar is Afsaneh Motamed Khorasani, a Medical and scientific Affairs expert and a Senior Scientist. Please visit to enroll for this webinar.

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:

  • 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).

Views: 35

Comment

You need to be a member of Online Safety Community to add comments!

Join Online Safety Community

Take our poll!

Take our poll!

Latest Activity

Mark Nilson posted an event

Managing Special Assignments: Advanced Best Practices for Administrative Professionals at Training Doyens 26468 E Walker Dr, Aurora, Colorado 80016

June 20, 2019 from 1pm to 2:30pm
OVERVIEWRefine your organizational skills to keep your projects on time, on budget, and on target. You've mastered the planning, executing, reviewing, and revising skills, making the difference between success and failure. You are good at getting the different stakeholders to provide information or direction and to show up for important milestones meetings.You're ready to hone your organizational and general administrative…See More
10 hours ago
Training Doyens posted an event
Thumbnail

Optimize Your Employee Onboarding: Techniques to Improve and Enhance the New Employee Experience at 26468 E Walker Dr, Aurora, Colorado 80016

June 18, 2019 from 1pm to 2pm
OVERVIEWIn this webinar, we will learn the reasons onboarding experience for new hires is important today. We will learn that the terms orientation and onboarding new employees are not interchangeable. We will learn that orientation is in reality just one step in the onboarding process. We will learn that the HR onboarding process begins before the hire is made.WHY SHOULD…See More
Wednesday
Mark Nilson posted events
Wednesday
Training Doyens posted events
Tuesday

Forum

Green Smart Technical 800+ Turnkey Projects in UAE – Rope Access Company in Dubai

Green smart is an ISO 9001: 2015 QMS, OHSAS 18001: 2017 OHSMS, ISO 14001: …Continue

Tags: window, cleaning, services, facade, companies

Started by Manikandan Apr 23.

Workplace safety for workers other than your own 2 Replies

Do your workplace/traffic safety plans include safety measures for workers who are not your own employees? Do they take into account the safety of those who will be - or could be - at your workplace,…Continue

Tags: emt, paramedics, emergency, occupational, health

Started by John Petropoulos Memorial Fund. Last reply by Tara safe Mar 1.

What % of Dollars should be bugeted for All Safety Training for a "Heavy Equipment Road Construction" company with 100 employees? 1 Reply

I have been at a Highway and Road Construction company for six months. I am developing a (first) complete training program. I am the 1st full time safety hire for this company. I need to develop a…Continue

Started by JTurpening. Last reply by Jen McDade Feb 19.

Technology and Safety 1 Reply

What are the most useful tools to have at your fingertips? -Toolbox Talks-JSA-JHA-Daily Reports, etc. What is falling through the cracks that could be an easy fix? Safety Managers, Coordinators and…Continue

Tags: safety

Started by Drew stone. Last reply by Jen McDade Feb 15.

Important of Warning sign 1 Reply

Warning sign is a type of traffic sign that guide a hazard ahead on the road. Having proper warning sign on the road provide a healthy environment.Continue

Tags: Signs, Workplace, Safety, Sign, Warning

Started by healthandsafetysigns. Last reply by Jen McDade Jan 14.

Badge

Loading…

© 2019   Created by Safety Community.   Powered by

Badges  |  Report an Issue  |  Terms of Service