All FDA Regulated Industry

$200.00
Establishing Appropriate Quality Metrics and Key Performance Indicators (KPIs)

 Recorded Webinar
 90 Minutes
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Establishing Appropriate Quality Metrics and Key Performance Indicators (KPIs)

Establishing appropriate Quality Assurance metrics is important for several reasons. Metrics not only measure the health of your quality system, but they also have the ability to change behavior, drive quality culture and improve both individual and company performance. This course will discuss the importance of establishing metrics, how to distinguish Key Performance Indicators (KPIs), as well as, how to u..

$200.00
EU MDR-Introduction into The European Medical Device Regulation

 Recorded Webinar
 90 Minutes
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EU MDR-Introduction into The European Medical Device Regulation

The EU MDR 745/2017 is a complete game change to the old law of the MDD 93/42/EEC since 1993 with a couple of updates. The time is very short and the number of requirements and required changes is high. The training will show how to conduct a gap-analysis, an action plan and how to be on track until May 2020. Learn what to do into the quality management department and what to do in the regulatory affairs de..

$200.00
EU Medical Devices Regulation: CE Mark Expiration and the EU Refusal of Your Exports

 Recorded Webinar
 60 Minutes
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EU Medical Devices Regulation: CE Mark Expiration and the EU Refusal of Your Exports

FDA and the EU have tried to harmonize device regulatory requirements for over 25 years. Major differences between the FDA and the EUincludepremarket authorization (CE Mark), complaint investigations, postmarket surveillance, and reports. The EU’s new Medical Devices Regulation (MDR) incorporates more rigorous regulatory requirements for those areas and in some cases outpaces the FDA’s requirements. The FDA..

$200.00
Extractables and Leacheables in Drug Development

 Recorded Webinar
 60 Minutes
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Extractables and Leacheables in Drug Development

Leachables from pharmaceutical container closure systems can present potential safety risks to patients. Extractables studies identify potential leachables and therefore assess and mitigate the above risks based on the dosage forms and the administration route. When safety concerns are detected, approaches for the toxicological evaluation of extractable and leachable have been developed and applied by pharm..

$200.00
False Claims Act (or Whistleblower Act) and Hospital Fraud

 Recorded Webinar
 60 Minutes
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False Claims Act (or Whistleblower Act) and Hospital Fraud

A whistleblower or qui tam action can provide financial rewards to individuals who provide information that a company, hospital, or individual has defrauded the government. The primary statutes under which this relief may be sought are the federal and state False Claims Acts (“FCAs”). State and federal governments pay hundreds of billions of dollars each year for pharmaceutical drugs, medical devices, hospi..

$200.00
Fatal FDA Inspection Mistakes

 Recorded Webinar
 60 Minutes
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Fatal FDA Inspection Mistakes

When FDA shows up at your door to announce an inspection, what do you think is going to happen? More importantly, what are you going to do?An ex-FDA investigator will conduct this webinar to share an “insider’s” perspective about inspections. What’s important, what’s not, and what is a fatal mistake on the part of a firm. Firms need an established FDA inspection protocol that describes what happens during a..

$200.00
FDA Adverse Event Reporting

 Recorded Webinar
 90 Minutes
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FDA Adverse Event Reporting

This training program will provide the regulatory requirements for complaint handling in the pharmaceutical & medical device industries. The course will touch on complaint sources and details will be furnished on the interrelationships regarding complaint handling and product recalls. The course will also include timeline requirements associated with adverse event reporting.   Areas Cover..

$200.00
FDA and Management Responsibility for Social Media Use

 Recorded Webinar
 60 Minutes
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FDA and Management Responsibility for Social Media Use

The use or participation in social media can lead to some surprising outcomes with the FDA. The sweeping statutory definition of “labeling” covers the use of information that appears in social media. There are several platforms that can present information either by you or a third-party, all of which can become an action by the FDA against the management’s actions or inactions. Firms should develop and impl..

$200.00
FDA Compliance and Clinical Trial Computer System Validation

 Recorded Webinar
 90 Minutes
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FDA Compliance and Clinical Trial Computer System Validation

The FDA governs the computer systems used to collect, analyze, transfer and report data that is in support of human clinical trials required for drug approval. FDA oversight is based on a Predicate Rule, known as “Good Clinical Practices,” or simply, “GCPs.” Computer systems subject to GCP requirements must be thoroughly and appropriately validated in accordance with FDA’s guidance on computer system valida..

$200.00
FDA Compliance and GAMP V Computer System Classification

 Recorded Webinar
 90 Minutes
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FDA Compliance and GAMP V Computer System Classification

We will discuss the importance of classifying computer systems subject to FDA regulations in accordance with GAMP V. 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 you do not go beyond what is required for a specific classification of the system so as to be cost-effective...

$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 ..

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