$200.00
Adverse Event Reporting Rules for Drugs, Dietary Supplements & Cosmetics

 Recorded Webinar
 60 Minutes
 Refer a Friend
Adverse Event Reporting Rules for Drugs, Dietary Supplements & Cosmetics

This event will cover everything you need to know about how to Define a Serious Adverse Event and FDA’s Serious Adverse Event (SAE) reporting requirements for OTC Drugs, Cosmetics and Dietary Supplements. It will also cover what to expect regarding reporting changes for Cosmetics when the Personal Care Products Safety Act is passed.All OTC drugs and Dietary Supplements are required to report Serious Adverse..

$200.00
Clinical Process Improvement

 Recorded Webinar
 90 Minutes
 Refer a Friend
Clinical Process Improvement

Effective process improvement can be key to reducing delays and improving data accuracy. In clinical trials, turnaround time and data accuracy are critical. Likewise, the contract research organization (CRO) level or the institutional review board (IRB) level can have serious downstream effects, negatively impacting study efficacy and time-to-market. It is essential, therefore, that all participants in cl..

$200.00
Establishing a Robust Supplier Management Program

 Recorded Webinar
 90 Minutes
 Refer a Friend
Establishing a Robust Supplier Management Program

Regulatory expectations are clear about manufactures’ responsibility regarding supplier quality oversight. All regulatory agencies agree that pharmaceutical and medical device manufacturers are responsible for ensuring their suppliers adhere to quality standards, maintain compliance with regulatory requirements and consistently meet established expectations. Therefore, it is essential pharmaceutical and med..

$200.00
How Successfully Apply for a Breakthrough Therapy Designation

 Recorded Webinar
 60 Minutes
 Refer a Friend
How Successfully Apply for a Breakthrough Therapy Designation

The Breakthrough Therapy Designation (BTD) is perhaps one of the most impactful incentives from the FDA as it helps get the product to market much faster than any other expedited approval pathway. Once a drug is successful in getting the BTD, the non-clinical and clinical requirements for market approval are significantly reduced. The applicants can request special meetings with FDA to discuss the developme..

$200.00
What You Should Know About Export Requirements for FDA Regulated Products from the US to Foreign Countries

 Recorded Webinar
 60 Minutes
 Refer a Friend
What You Should Know About Export Requirements for FDA Regulated Products from the US to Foreign Countries

This training will provide an in-depth explanation of FDA-Regulated Products that were exported from the United States to Foreign Countries. Also, it will address what export documentation must be used in the transportation of FDA-regulated products. Then, it also will discuss the FDA procedures that exporter must comply to in order to meet the Modernization Act agreement. Lastly, it explains what local gov..

$200.00
A Leer, A Pat, A Joke, A Gesture, An Innuendo, A Kiss: Are You Prepared To Be the Next Social Media Blitz, Identified on #MeToo, or a Headline in the Newspaper?

 Recorded Webinar
 90 Minutes
 Refer a Friend
A Leer, A Pat, A Joke, A Gesture, An Innuendo, A Kiss: Are You Prepared To Be the Next Social Media Blitz, Identified on #MeToo, or a Headline in the Newspaper?

Harvey Weinstein, Matt Lauer, Charlie Rose, Al Franken, Garrison Keillor, members of Congress, and various State lawmakers have been accused of sexual harassment and/or sexual assault. But there is a difference between pulling one’s pants down in front of a female colleague at work and touching a woman on her buttocks during a photo op—isn’t there? What is that difference? Are both examples considered sexua..

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

 Recorded Webinar
 60 Minutes
 Refer a Friend
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, hospit..

$200.00
Data Governance for Computer Systems Regulated by FDA

 Recorded Webinar
 90 Minutes
 Refer a Friend
Data Governance for Computer Systems Regulated by FDA

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 Compliance and GAMP V Computer System Classification

 Recorded Webinar
 90 Minutes
 Refer a Friend
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
Save Your Food Business!!-Business Continuity and Disaster Recovery

 Recorded Webinar
 90 Minutes
 Refer a Friend
Save Your Food Business!!-Business Continuity and Disaster Recovery

Disasters and disruptions of business rarely occur, but if they do they can be costly and dangerous. In R&D, Manufacturing & Retail areas of a food company, there can be dangerous contaminants and other disasters and important data and business processes that could be lost. Every company has a responsibility to their stakeholders (clients, shareholders, employees) and to regulators, to take steps to..

$200.00
GMP Environmental Monitoring for Pharmaceutical Clean Rooms

 Recorded Webinar
 60 Minutes
 Refer a Friend
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..

$200.00
Best Practices in Preparation for an FDA Computer System Validation Audit

 Recorded Webinar
 90 Minutes
 Refer a Friend
Best Practices in Preparation for an FDA Computer System Validation Audit

Effective and compliant computer system validation is critical to any pharmaceutical or FDA-regulated organization. Following best practices for developing a validation program that includes planning, execution and maintenance components will ensure that these efforts will meet all regulatory agency requirements and expectations. Preparedness will improve your relationship with the agency and ensure a more ..

$200.00
Best Practices for Investigating Deviations

 Recorded Webinar
 60 Minutes
 Refer a Friend
Best Practices for Investigating Deviations

One of the most common FDA 483 and Warning Letter citations continues to be inadequate investigations. The FDA uses the investigation reports and investigation trends to identify potential quality problems in all areas of the company. Ultimately, inadequate investigations can lead to 483 citations, Warning Letters, a release of the sub-standard product, or product recall. Furthermore, costly and time-consum..

$200.00
FDA’s Cloud Compliance and Regulations

 Recorded Webinar
 90 Minutes
 Refer a Friend
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, ..

$200.00
How to Write Effective 483 and Warning Letter Responses

 Recorded Webinar
 90 Minutes
 Refer a Friend
How to Write Effective 483 and Warning Letter Responses

The outcome of regulatory inspections is critical to an organization’s success. If the outcome of the inspection results in FDA 483 observations or a warning letter, it is important to take the observations and subsequent responses very serious. This course will discuss the importance of developing and submitting a robust, timely response to FDA 483 observations or warning letters; as well as, educate the a..

Showing 1 to 15 of 167 (12 Pages)