All FDA Regulated Industry

$200.00
FDA Compliance and Mobile Applications

 Recorded Webinar
 90 Minutes
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FDA Compliance and Mobile Applications

We will discuss in detail how computer system validation can be applied to mobile applications subject to FDA regulations. This is critical in order to develop the appropriate validation strategy and achieve the thoroughness required to prove that a system does what it purports to do. It also ensures that a system is maintained in a validated state throughout its entire life cycle, from conception through r..

$200.00
FDA Deeming Rule for Tobacco Related Products and Recent Actions:  eCigarettes, eLiquids, Cigars

 Recorded Webinar
 90 Minutes
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FDA Deeming Rule for Tobacco Related Products and Recent Actions: eCigarettes, eLiquids, Cigars

This webinar is intended for those working in the FDA-regulated tobacco and related industries, including e-liquids (vapor), e-cigarettes, cigars, and smokeless tobacco products. Functions that are applicable include research and development, manufacturing, Quality Control, distribution, clinical testing and management, adverse events management and post-marketing surveillance.You should attend this webinar..

$200.00
FDA Import Program with COVID-19

 Recorded Webinar
 60 Minutes
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FDA Import Program with COVID-19

Importing FDA regulated product faces new challenges, new risk management procedures, and mitigation of business consequences that will affect corporate profits. Basic issues should be evaluated and updated to help you plan for unprecedented problems and your helplessness to escape the trauma. The COVID-19 creates a global bondage on commerce and drains, if not dries up, the supply of necessary products to ..

$200.00
FDA Inspections: Prepare and Survive

 Recorded Webinar
 60 Minutes
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FDA Inspections: Prepare and Survive

FDA conducts establishment inspections to determine a firm’s conformance to applicable regulatory requirements. Inspections vary based on the type of product you make or plan to make. FDA prioritizes domestic and foreign inspection assignments based on three factors. However, with the current public health crisis with COVID-19, FDA is overwhelmed with work at this time, so it will likely rely on new approac..

$200.00
FDA Meeting Requests , Preparation and Conduct

 Recorded Webinar
 90 Minutes
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FDA Meeting Requests , Preparation and Conduct

The FDA has published guidance regarding the types of meetings that will generally be granted and the information needed to conduct the meeting. However, the guidance tends to be general and interpreted in multiple ways. This topic will provide practical examples and suggestions for standard meetings as well as requesting and conducting non-typical meetings (such as during fast track, the clinical hold, or ..

$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
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..

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