We provide online regulatory training and quality compliance training through live interactive webinars on hot topics, approval process, standards & Best Practices, guidelines, and regulations at a global level, presented by experts in the fields of life sciences (drugs, excipients, devices, combination products), food & food ingredients, dietary supplements, and complementary medicine. All live interactive webinars are recorded and offered as on-demand webinars, so you can view at your convenience.
We also provide self-paced, interactive e-learning modules of different lengths on these subjects, presented by industry experts, at a global level.
There are some interviews, talks and group discussions of different lengths on our YouTube channel as well. Furthermore, we provide different types of high-quality forms and templates, across many different fields to keep you up to date with the latest happening.
This 60 minute On-Demand Good Documentation Guidelines (USP <1029>) Webinar will familiarize you with the US Pharmacopoeia General Chapter <1029> in Good Documentation Guidelines, which adds some high level information to all other Good documentation rules and regulations out there.This USP Chapter wraps up the general concept and provides the information as to what needs to be documented in certain records.
A series of graphic aids (11 Human Subject Regulations Decision Charts) for entities who decide if an activity is research involving human subjects that must be reviewed by an IRB under the requirements of the US Department of Health and Human Services (HHS) regulations at 45CFR part 46.
Using this Expedited Adverse Event Reportability Assessment Chart, you will learn how to follow the thought process for decisions on whether an adverse event is subject to expedited reporting or not.
This 3 minute YouTube clip (EASY GLOBAL TRAINING Company Profile) is intended to provide a very brief overview of our services and subject matters we cover. In brief, we provide training/educational pieces of different format and length in regulatory and quality compliance as well as Best Practices in the pharmaceutical, medical device, Recipients, Foods, and Dietary Supplements. To support you even further, we provide consulting services (remote and on-site) for all these areas as well. The list of our consulting services are also listed in this YouTube clip.
This 8 minute YouTube clip (Introduction to EASY GLOBAL TRAINING) is intended to provide a very brief overview of our services and subject matters we cover. In brief, we provide training/educational pieces of different format and length in regulatory and quality compliance as well as Best Practices in the pharmaceutical, medical device, Recipients, Foods, and Dietary Supplements. To support you even further, we provide consulting services (remote and on-site) for all these areas as well. The list of our consulting services are also listed in this YouTube clip.
ID: 1326
SKU: OW-0002-BP
Type: On-Demand Webinar
Following the completion of this 100 minute On-Demand Good Documentation Practices Webinar, you will gain a moderate / advanced knowledge of definition, purpose, importance of GDP, General rules of GDP, GDP as applies to laboratory notebook documentation, US Pharmacopoeia 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.
This is a 2-page MS Word Standard Operating Procedure Template to be used as a starting point for preparing a standard SOP. We have included a proposed structure for an SOP as well as draft language and other guidance to assist you in creating a good SOP. We have saved this template in different formats (.docx, .dotm, .dotx, .docm, .doc, and .dot) to make sure it is compatible with all systems.
In this 27-page comprehensive guide (Standard Operating Procedure e-Book), you will learn how to produce an effective SOP. We have included a proposed structure for an SOP as well as draft language and other guidance to assist you in creating a good SOP.
This 9-page e-Book (The Basics of Medical Review e-Book) provides a brief explanation on the role of Medical Monitoring and the importance of Medical Monitoring, the minimum items to be included in the SAE Medical Review Form along with a template to enable you to create your own Medical Monitoring Forms.
This 33-page Investigator’s Brochure Template is intended to assist you in the process of drafting an Investigator’s brochure for drugs based on ICH Topic E 6 (R1) “Guideline for Good Clinical Practice”.
This 21-page Investigator’s Brochure Template is intended to assist you in the process of drafting an Investigator’s brochure for Devices, based on ICH Topic E 6 (R1) “Guideline for Good Clinical Practice”.
In this comprehensive guide (Safety Data Sheets and HazCom 2012 Compliance e-Book), you will learn how to produce or read a safety data sheet. Furthermore, we have included an example for every single section we have discussed to be included in the SDS. We have included a proposed structure for an SDS as well as guidance to assist you in creating a good compliant SDS. We have saved this template in .docx format.
In this comprehensive guide (21 CFR Part 11 e-Book), Part 11 is discussed since it remains in effect during FDA reexamination period. Also, we elaborate on the latest guidance published in Aug 2003.
In this comprehensive e-Book (Good Documentation Practices), the essentials of GDP, its definition, purpose, and importance are explored first, followed by expanding on general rules and principles of GDP (ISO, ICH, FDA, EMA, USP), general tips for Laboratory Notebook documentation, and GDP enforcement by regulatory bodies in different countries with some examples of FDA citations and observations.
In this comprehensive e-Book (USP Chapter <1029>), the US Pharmacopeia General Chapter <1029> and all aspects of GDP including practices for writing and correcting documentation is explained. It expands on the general concept and provides information as to what needs to be documented in certain records.
This comprehensive e-Book “Laboratory Notebook Documentation” covers the essentials of GDP, its definition, purpose, and importance. Then expands on general rules and principles of GDP in Laboratory Notebook documentation with real-life examples to help you grasp the concepts discussed.
This comprehensive e-Book “GDP for Medicinal Products in the European Union” covers the general rules and principles of GDP based on EudraLex “The rules governing medicinal products in the European Union (EU).” In the volume 4 of this document titled “Good Manufacturing Practice – Medicinal Products for Human and Veterinary Use”, Chapter 4 is titled “documentation”.
This comprehensive e-Book “GDP for Nonclinical Laboratory Studies (21 CFR Part 58)” covers the essentials of GDP, its definition, purpose, and importance. Then expands on records attributes as well as the general rules and principles of GDP in non-clinical laboratory study documentation. 21 CFR Part 58 covers the GMP (including GDP) regulations for non-clinical laboratory studies.
This comprehensive e-Book “PICO Question in Evidence Based Research” focuses on how to formulate a question that can be properly answered in the area of public health services research.
This 1.5 minute YouTube Clip (EASY GLOBAL TRAINING Infomercial) is intended to provide a very brief overview of our services and subject matters we cover. In brief, we provide training/educational pieces of different format and length in regulatory and quality compliance as well as Best Practices in the pharmaceutical, medical device, Recipients, Foods, and Dietary Supplements. To support you even further, we provide consulting services (remote and on-site) for all these areas as well.
This one day On-in-class course covers the essentials of GDP, its definition, purpose, and importance. Then expands on general rules and principles of GDP (US & EU), GDP as applies to laboratory notebook (paper and electronic) documentation, and GMP on non-clinical laboratory studies (21 CFR Part 58), document and record keeping best practices specifically as it applies to drugs and devices (21 CFR Parts 212, 211, 312, and 812), USP General Chapter <1029>, Rules Governing Medicinal Products in the European Union (Vol. 4: Documentation), and finally discussing GDP enforcement by regulatory bodies in different countries with some examples of FDA citations.
This 13-page template is intended to assist you in the process of creating a medical monitoring plan for the clinical trials.
This 31-page GLP inspection template is intended to assist you in the process of auditing for GLP compliance.
