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Curious about Good Laboratory Practice (GLP) and its role in ensuring reliable and traceable scientific data? In this video, we introduce the fundamentals of GLP and why it's essential in laboratory environments within regulated industries. This video is part of our online course **“Introduction to Good Laboratory Practice (GLP ...

What are the U.S. FDA’s key requirements for manufacturing finished pharmaceutical products? In this video, we introduce **CFRs Part 210 and 211**, which outline the **current Good Manufacturing Practices (cGMPs)** that pharmaceutical companies must follow to ensure product quality, safety, and consistency. This video is part of our online ...

How can you ensure your electronic records and signatures meet FDA compliance standards? In this video, we introduce **FDA 21 CFR Part 11**, the essential regulation for handling electronic data in the life sciences sector. This video is part of our online course **“Introduction to FDA 21 CFR Part 11”**, tailored for professionals in ...

How can pharmaceutical companies ensure drug safety even after products are on the market? In this video, we introduce the fundamentals of **Good Pharmacovigilance Practice (GVP)**—a vital framework for monitoring, evaluating, and preventing adverse effects of medicinal products. This video is part of our online course **“Introduction to ...

How can manufacturers of medical devices ensure product quality, safety, and compliance with U.S. regulations? In this video, we introduce the principles of **Good Manufacturing Practice (GMP)** for medical devices, with a focus on **FDA 21 CFR Part 820**, also known as the Quality System Regulation (QSR). This video is part of our online ...

How can laboratories ensure the reliability of clinical trial data while maintaining regulatory compliance? In this video, we introduce the principles of **Good Clinical Laboratory Practice (GCLP)**—a vital standard that bridges Good Laboratory Practice (GLP) and Good Clinical Practice (GCP). This video is part of our online course **“Good ...

What Are Clinical Practice Guidelines In Nursing? In this informative video, we will discuss Clinical Practice Guidelines in nursing and their role in enhancing patient care. These guidelines are essential for nurses as they provide a structured approach to making informed decisions about patient treatment. We’ll cover how these guidelines ...

Good Clinical Practice - good clinical practice (GCP). This is a short video explaining the concepts of good clinical practice (GCP). This video features an insight into the clinical trial industry by focusing on the guidance for good clinical practice. Nowadays good clinical practices can be applied to different aspects of any given company ...

Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording, and reporting trials that involve the participation of human subjects. Compliance with this standard provides public assurance that the rights, safety, and well-being of trial subjects are protected, consistent with the ...

What everybody should know about Clinical Trials! Without clinical trials, we wouldn’t have any vaccines, treatments for cancer, heart disease, diabetes and many others. What should everybody know about Clinical Trials? How are pharmaceuticals and medical devices developed? This is our new video of our series about the basics of clinical ...

What does it take to run ethical, high-quality clinical trials that meet global standards? In this video, we introduce the key concepts behind **Good Clinical Practice (GCP)** according to the ICH guidelines, essential for anyone involved in clinical research. This video is part of our online course **“ICH-GCP: Introduction to Good Clinical ...

Are you up to date with the latest Good Clinical Practice (GCP) standards? In this video, we present the 2025 refresher on **ICH-GCP**, essential for clinical research professionals who need to maintain their compliance and ethical conduct in clinical trials. This video is part of our online course **“ICH-GCP Training Refresher 2025: Good ...

Good clinical practice provides a framework of principles which aim to ensure the safety of research participants and the integrity and validity of data

Both the guidelines will have 13 important principles, these principles will give information regarding how to conduct a clinical trial.

This European Code of Good Practice outlines the minimum operational requirements for medical centres providing hyperbaric therapies. It applies to all facilities using monoplace or multiplace chambers for treatment and research. The document details guidelines for staffing, equipment, gas supply, risk management, and safety procedures for ...

Video made possible thanks to AI voice generator Eleven Labs, https://elevenlabs.io/?from=josephalexandernordqvistcantoral8044 Join this channel to get access to perks: https://www.youtube.com/channel/UCI8Xs2oPTMb9DkuYsEqCnnQ/join Good laboratory practice, or GLP, are accepted methods to carry out activities or operations in non-clinical ...

What does "current" mean in Good Practices, and why is it essential to stay up to date in regulated industries? In this video, we introduce **Current Good Practice (cGxP)**—a foundational concept ensuring that pharmaceutical and life sciences organizations meet modern standards of quality and compliance. This video is part of our online ...

What are the key differences between **EU and FDA GMP requirements** for medical devices? In this video, we compare the European Union and U.S. regulatory approaches to **Good Manufacturing Practice (GMP)**, helping you understand how to stay compliant in both markets. This video is part of our online course **“GMP for Medical Devices: EU ...

In this insightful video, we dive deep into Good Manufacturing Practices (GMP) in the pharmaceutical industry, exploring how these essential guidelines ensure the highest quality in drug production. Discover the critical steps involved in maintaining compliance, enhancing safety, and guaranteeing efficacy in pharmaceuticals. From raw material ...

Chapter 4 : PRINCIPLES OF GOOD CLINICAL PRACTICE is a part of the YouTube series "Clinical Researcher" by Dr. Sulaiman Sait. Clinical Researcher is your destination to learn everything about Clinical Research. This video lecture features an insight into the Clinical Trial Industry by focusing on the guidance for good clinical practice. ICH-GCP ...

Overview of historical events that preceded and directly or indirectly led to Good Clinical Practice (GCP) development as an international guideline. #clinicalresearch #clinicaltrials #goodclinicalpractice #history #gcp

This is a PowerPoint course with Audio and will guide you through all aspects surrounding ICH GCP guidelines and regulations and is aimed at those interested or working within Clinical Research. It is suitable for anyone carrying out or involved in clinical research and will provide individuals with official certification in GCP that is widely ...

This is the first video presentation in the series related to Good Clinical Practices (GCP). Every video presentation in the series will try to give additional explanations about GCP topics. In this video, we shall try to explain the principles of GCP in more detail. If you want to know more about historical events that led to GCP and more ...

This video describes what guidelines are and reviews some of the Institute of Medicine's attributes of trustworthy guidelines

This video contains various tricks to remember ICH-GCP 13 Guidelines in order, in addition to it other information which would be helpful to students who want to pursue their career in clinical research.

This video contains complete discussion of Good Documentation Practice (GDP) In Pharma industry. Copyright Disclaimer - The video is for educational purpose only. Copyright Disclaimer Under Section 107 of the Copyright Act 1976, allowance is made for "fair use" for purposes such as criticism, comment, news reporting, teaching, scholarship, and ...

How do nonclinical laboratories ensure the integrity, reliability, and traceability of safety data? In this video, we introduce the key requirements of **21 CFR Part 58**, the U.S. FDA regulation that defines **Good Laboratory Practice (GLP)** for nonclinical studies supporting research and regulatory submissions. This video is part of our ...

FDA discusses key issues in reviewing first-in-human clinical protocols for cellular and gene therapy products for the treatment of cancer. FDA also shares pitfalls to avoid when describing these studies and lessons learned from successful oncology and gene therapy products. Presenter: Peter Bross, MD, Chief (Acting), Oncology Branch, Division ...

This web seminar provides the basic concept of Good Clinical Practice (GCP). Participants will learn the goals of GCP and its common elements (FDA regulations and ICH Guidelines) defining the quality system of mutual accountability between the sponsor, investigator, IRB/IEC, and the regulatory authority. The basic roles and responsibilities of ...

Boost Your Pharma Knowledge with Our Exclusive Courses! 🚀📚 Explore our in-depth courses designed for pharmaceutical professionals and students. Gain industry-relevant skills, stay compliant with regulations, and advance your career with expert-led training. 📌 Featured Courses: https://www.youtube.com/playlist?list=PL ...

Address for person and students who are interested in training and consultancy service- B.R. NAHATA COLLEGE OF PHARMACY, NEAR KRISHI UPAJ MANDI, MHOW- NEEMUCH ROAD, mandsaur (M.P.) 458001 PHONE NUMBER-9501846476, 9630301810 E MAIL ID-(1) DIRECTOR.BRNCOP@MEU.EDU.IN (2) KARAN.GUPTA@MEU.EDU.IN FaceBook - https://www.facebook.com/profile.php ...

Learn about GMP guidelines, how to uphold GMP standards, and technology for commercial and industrial good manufacturing practices (GMPs).

FDA discusses the purposes, conduct, and expectations of FDA drug manufacturing inspections. The presentation covers how to prepare for, host, and respond to such inspections, as well as the inspection’s potential consequences. Presenter: Russell K. Riley, Compliance Officer Division of Pharmaceutical Quality Operations III| Office of ...

1:30 Spectrum of Technical Writing 1:42 Audience Analysis 3:00 Types of Audiences 4:00 GDocP (Good Documentation Practices) 11:50 Tables and Graphs 14:10 Concrete and Specific Writing Style If you're interested in learning more about good documentation practices, then download our syllabus to the technical writing courses that we provide on ...

Good Documentation Practices is an essential skill you need to have when you’re working in the life science sector. GDocP is not just about initials and dates (although it does play a big part of it) it’s about doing things the right way and making everything you do transparent. Link to course: http://www.learnaboutgmp.com/e-learning/good ...

Overview of the FDA Good Manufacturing Practices (GMP or cGMP) for Finished Pharmaceuticals. You can take the full course at: http://www.caliso9000.com/pharmaceutical_gmp.html Join our Blog at: http://www.iso-9001-caliso.blogspot.fr or our Facebook page: https://www.facebook.com/calisocorporation

Boost Your Pharma Knowledge with Our Exclusive Courses! 🚀📚 Explore our in-depth courses designed for pharmaceutical professionals and students. Gain industry-relevant skills, stay compliant with regulations, and advance your career with expert-led training. 📌 Featured Courses: https://www.youtube.com/playlist?list=PL ...

Welcome to Nursing Education, your trusted source for high-quality nursing learning content! In today’s video, we are presenting a complete and detailed Nursing Care Plan on Pneumonia, designed especially for BSc Nursing, GNM Nursing, and Post-Basic Nursing students, as well as for practicing nurses who are preparing for exams or clinical ...

Hanan Ghantous covers the role and responsibilities of the pharmacology/toxicology reviewer related to the various components of the Investigational New Drug (IND) phase of drug development. This presentation covers both scientific and regulatory pharmacology/toxicology concepts that are part of the non-clinical submission to an IND/ NDA/BLA ...

How can you ensure that investigational products used in clinical trials meet the highest standards of quality and safety? In this video, we explore the principles of **Good Manufacturing Practice (GMP)** as they apply to the **manufacture and supply of clinical trial materials**. This video is part of our online course **“GMP for Clinical ...

Good documentation practices are where you have written procedures, follow them and record all of your results. There are a number of rules to good documentation practice: 1. If it was not documented, it did not happen 2. If it was documented, but poorly, it did not happen either 3. Do not forget rules 1 and 2. 4. My Rule 4 – if if was dodgy ...

This Joint US-FDA, MHRA-UK, Health Canada workshop focused on Global Clinical Trials in Good Clinical Practice, Bioequivalence, and Pharmacovigilance in the post pandemic world. Panelists discussed continuing developments in novel operational approaches, data sources, and technologies used in clinicals trials, as well as novel approaches to ...

Good Laboratory Practice (GLP) Overview training based on the FDA's 21 CFR 58. Full course at: http://www.caliso9000.com/fda_GLP.html Join our Blog at: http://www.iso-9001-caliso.blogspot.fr or our Facebook page: https://www.facebook.com/calisocorporation

Good laboratory practices (GLP) are essential for ensuring accuracy and precision in microbiology testing. In this video, we will discuss the importance of GLP in microbiology, including the regulatory requirements and the consequences of non-compliance. We will also cover the key elements of GLP, such as personnel, facilities, equipment ...

Want to ensure your documentation meets the highest standards in regulated environments? In this video, we cover the fundamentals of **Good Documentation Practice (GDocP)** and why accurate, consistent, and traceable records are essential in the pharmaceutical and healthcare industries. This video is part of our comprehensive online course ...

Christine Le from CDER’s Office of Generic Drugs discusses the product-specific guidance (PSG) development processes including how collaborative efforts on how PSGs are prioritized, developed and published. She also shares PSG webpages including the upcoming PSGs for complex generic drug product development webpage as well as an overview on ...

For more information visit https://www.miltenyibiotec.com/products/cell-manufacturing-platform.html The quality of starting materials dramatically influences the properties of the final cellular product. Therefore the ultimate success of your cell product depends on the quality of the raw materials used. For the development of cell-based and ...

Dr.Naeem Noordin, SIARA Limited UK Good Clinical Practice (GCP) What is Good Clinical Practice? Good Clinical Practice (GCP) is an international ethical and scientific standard for conducting biomedical and behavioral research involving human participants. The objective of this guideline is to provide a unified standard to facilitate the mutual ...

This hand drawn white board video illustrates the 5 important stages of drug approval by the FDA. Discovery and Screening, IND Application Submission, Clinical Trials, Application Review and Inspections, and Safety Monitoring.

John Concato, MD, MS MPH, acting associate director of real-world evidence analytics in the Office of Medical Policy, discusses the creation of the FDA guidance “Conducting Clinical Trails of Medical Products During the COVID-19 Public Health Emergency and the opening of the Clinicaltrialconduct-COVID19@fda.hhs.gov mailbox; and their role in ...