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..
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..
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..
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..
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..
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...
This 60-minute presentation will highlight the use of statistical tools to monitor operations for a proactive operation.There are always certain steps in a method where control is critical either because this step contributes a lot to the overall uncertainty or its uncertainty is more likely to change from common causes. These critical points can be assessed and a monitoring program instituted. This data is..
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..
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 ..
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..
Instrumental liquid chromatography, either as HPLC or UPLC, are common techniques in laboratories that do regulatory-compliance work. For Good Laboratory Practice (GLP) or for ISO 17025 compliance, such methods must meet certain requirements. This presentation will cover the key elements to have a compliant method.Instrumental liquid chromatography is an analysis is widely used to determine purity, the impu..
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 ..
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..
Complaint handling is likely one of the more cross-functional parts of your quality system: Customer Service may receive your customer complaints, Sales and Marketing may need to reach out to the customer for additional information, Regulatory Affairs may determine whether the complaint is reportable, QA may perform the root cause investigation, R&D or Manufacturing Engineering may need to be involved i..
This program will address approaches to regulatory affairs project management for clinical trial applications, marketing authorization applications, and ongoing management of regulatory obligations. The information obtained will enable effective management and tracking of time and resources to complete the project objectives and ensure regulatory compliance.Learning ObjectivesSetting tasks focused on projec..