All FDA Regulated Industry

$200.00
FDA Regulation of Artificial Intelligence/Machine Learning

 Recorded Webinar
 60 Minutes
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FDA Regulation of Artificial Intelligence/Machine Learning

AI/ML will revolutionize medicine by making diagnosis and treatment more accessible and more effective. FDA has regulated medical software by means of regulation and guidance for years, however, AI/ML programs fall outside the scope of these regulations and guidance. This happens because the FDA approves the final, validated version of the software. The point of AI/ML is to learn and update the ..

$200.00
FDA Regulations Associated with the Detection, Correction and Prevention of Human Errors in GMP Manufacturing and Laboratory Processes

 Recorded Webinar
 90 Minutes
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FDA Regulations Associated with the Detection, Correction and Prevention of Human Errors in GMP Manufacturing and Laboratory Processes

We are often quick to ascribe fault to people rather than our systems, facilities, and operations. However, in this class, we will learn how to tell if you are too quick to ascribe guilt to people rather than probe deeper. We will focus on improved techniques to get to the real cause of the problem. With this information, you will be able to develop meaningful CAPAs that have a chance to remedy these proble..

$200.00
FDA's Recent Clarification on Guidance for Managing Data Integrity for Regulated Systems

 Recorded Webinar
 90 Minutes
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FDA's Recent Clarification on Guidance for Managing Data Integrity for Regulated Systems

Effective and compliant computer system data management is critical to organizations in the pharmaceutical, biologics, vaccines, tobacco, animal health, medical device or other FDA-regulated industry. During the past 30 years, best practices have been developed to ensure computer systems used in these environments can be cost-effectively managed while meeting all aspects of FDA compliance. To take this a st..

$200.00
FDA’s and U.S. Custom’s Import Entry Program

 Recorded Webinar
 60 Minutes
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FDA’s and U.S. Custom’s Import Entry Program

The webinar address the critical elements of information required to present a product for entry into the U.S.  We will cover what information for FDA is mandatory. You must use the new software program, Automated Commercial Environment (ACE), you need to decide on who will do that, establish operational procedures and what to do if your entry is detained. The course will explain how you can make your ..

$200.00
FDA’s Cloud Compliance and Regulations

 Recorded Webinar
 90 Minutes
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FDA’s Cloud Compliance and Regulations

The evolution of computerized technologies has been both amazing and challenging. Each new wave of technological evolution has been accompanied by a series of compliance challenges, and subsequent strategies to comply with applicable regulatory requirements. Cloud computing is a current example of this evolution. This presentation will provide a discussion of Cloud concepts, terminology, definitions, archit..

$200.00
FDA’s GMP expectations for Phase I & First-IN-Man Clinical Trials

 Recorded Webinar
 90 Minutes
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FDA’s GMP expectations for Phase I & First-IN-Man Clinical Trials

This Webinar will provide details on GMP requirements throughout all phases of development and commercialization.Following Good Manufacturing Practices (GMPs) is a mandatory legal requirement from clinical studies through-out marketing. Early clinical trials are conducted to establish the initial safety of a drug. The studies are generally in a small number of healthy subjects and use lower doses of the dru..

$200.00
FDA’s Scrutiny of Social Media and Corporate Responsibility

 Recorded Webinar
 60 Minutes
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FDA’s Scrutiny of Social Media and Corporate Responsibility

Off-label promotion falls within the scope of labeling requirements as defined by the Federal Food, Drug, and Cosmetic Act, as amended (FDCA).  FDA’s application of labeling requirements to the information posted in social media of any type creates a new field of enforcement opportunity, one that may catch you by surprise. If off-label statements, whether express or implied, end up directly or indirect..

$200.00
FDA’s Scrutiny of Social Media Off-Label Promotion

 Recorded Webinar
 60 Minutes
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FDA’s Scrutiny of Social Media Off-Label Promotion

FDA’s regulation of social media operates as a moving target. What is OK or not OK remains vague, perhaps purposely so. All social media platforms provide an easy common way to cross the FDA’s legal boundaries for “misbranding” your product, whether knowingly or unknowingly. In the end, your firm’s executive management ends up with the legal responsibility for the enforcement action. A regulatory monster lu..

$200.00
Food Labeling In MX

 Recorded Webinar
 180 Minutes
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Food Labeling In MX

General Mexican labeling specifications for pre-packaged foods and non-alcoholic beverages have been submitted to different changes due to health policies in Mexico. In order to comply with the new guidelines, you’ll need to cover numerous rules, standards, and some other regulations.Receive the most up-to-date information first-hand from an industry expert that collaborated through the ICC in the most rece..

$200.00
Food Waste Reduction: The road to Cost Reductions and Sustainability

 Recorded Webinar
 75 Minutes
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Food Waste Reduction: The road to Cost Reductions and Sustainability

Food waste is a well-recognized issue throughout the food supply chain. Loss estimates run anywhere from 30% to 50%. Water, fertilizer, manpower, facility overhead costs, delivery/planting/production/storage and delivery, carbon emissions, environmental pollution, and other food production expenses are lost along with the food that cannot be consumed.Food waste, as defined by the U.N.’s Food and Agriculture..

$200.00
Functional System Requirements for Computer Systems Regulated by FDA

 Recorded Webinar
 90 Minutes
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Functional System Requirements for Computer Systems Regulated by FDA

We will discuss the importance of applying industry best practices when performing the validation process for a computerized system used in an FDA-regulated environment (i.e., the system "touches" product during the manufacturing, testing or distribution process). Such a system must be validated in accordance with FDA guidelines for computerized systems and documented accordingly. Defining the functional re..

$200.00
Functional System Requirements Planning for Computer Systems Regulated by FDA

 Recorded Webinar
 60 Minutes
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Functional System Requirements Planning for Computer Systems Regulated by FDA

This course is intended to provide specific guidelines for coaching attendees on the best practices for developing requirements for computer systems regulated by FDA. There are several key types of requirements that will be covered, including user, functional, performance, system, environmental and other categories.The attendee will learn about the requirements for planning, executing and documenting the re..

$200.00
Fundamentals of Good Manufacturing Practices (GMP) - Developing a Compliance Mindset

 Recorded Webinar
 60 Minutes
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Fundamentals of Good Manufacturing Practices (GMP) - Developing a Compliance Mindset

A discussion of the basic principles and requirements for Good Manufacturing Practices. The presentation provides a brief history and basis for the existence of GMPs, a discussion of what they cover, and examples of real-life situations along with a discussion of possible responses and the reasons one or more responses may be appropriate or not.Learning ObjectivesFundamental requirements of Good Manufacturi..

$200.00
Generation of Controlled Documents and Related Training

 Recorded Webinar
 60 Minutes
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Generation of Controlled Documents and Related Training

This presentation is intended to provide the needed documentation practices associated with documentation creation, document approval, handwritten entries, copies of documents, document maintenance and document modification. This document details the minimum documentation requirements for MEDIn still personnel, contractors and consultants completing cGMP documents. Specific operational procedures using more..

$200.00
GMP Environmental Monitoring for Pharmaceutical Clean Rooms

 Recorded Webinar
 60 Minutes
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GMP Environmental Monitoring for Pharmaceutical Clean Rooms

Environmental Monitoring looks at the end results of the Environmental Control program – the microbiological and particulate quality of the clean room. As the FDA Guideline on Aseptic Processing GMP (2004) states: “In aseptic processing, one of the most important laboratory controls is the environmental monitoring program. This program provides meaningful information on the quality of the aseptic processing..

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