This webinar will present and apply FBI, FDA and EPA approved methods for the determination of limits of detection (LOD) and limits of quantitation (LOQ) in chemical forensic and environmental analysis. These methods apply to most analytical techniques including gas and liquid chromatography, mass spectrometry, and elemental and molecular spectroscopy and can be used when analyzing blood, urine, food, or trace evidence for the presence of toxic chemicals or drugs.
Join Elaine Eisenbeisz as she shows you how to use data to estimate a standard curve, how to perform computations for absolute and relative quantification. She will also present a few decision-making criteria and statistical tests that can be used with qPCR data.
MIPS Data Validation Audits started in June of 2019. The MIPS has a number of vulnerabilities related to its reporting requirements and associated complexities. This presentation will address potential vulnerabilities and provide specific recommendations that will help protect your practice from a negative audit.
This webinar will cover strategies to improve the efficiency of your Quality Management System (QMS) for medical device companies. It will get you started in setting up a quality system that reduces compliance burden. We’ll. discuss techniques for improving efficiency, reducing burden, and still maintain an effective QMS.
Non-conforming material happens. And medical device companies must deal it. This 90-minute webinar will help you to make sense of confusing regulations and effectively deal with non-conforming material. You’ll learn how to identify, segregate, control, and disposition non-conforming material. You’ll learn about when and how to conduct failure investigations and requirements for correction and corrective action.
cGMP drug products rely on the bacterial endotoxin test as a critical release test for products based on the route of administration of the drug product. Having a good concept of this critical release assay, its application and importance to the manufacture of cGMP product is valuable as to avoid costly errors, batch disposal, expensive failure investigations and delays in the release of products that some manufacturers have undergone.
This webinar will provide an overview of setting and maintaining specifications for Pharmaceutical and Biotechnology derived drug products throughout its shelf-life.
This onboarding course is geared toward the pharmaceutical industry, particularly for anyone who is responsible for managing or delivering training in a GMP environment, and HR employees who interact frequently with the GMP training organization to coordinate onboarding. The aim of the course is to provide practical information, which has already been used on the job effectively, and suggest similar actions that learners can apply to their job situations quickly.
This session will address factors that food companies need to consider before making decisions on outsourcing analytical food testing or retaining an in-house laboratory and the pros and cons of each approach.
This webinar will help you to develop a Quality Management System (QMS) for Medical Device Companies. An effective QMS sends a message to the FDA and other regulators that your QMS is complete, accurate, and consistently followed. More importantly, it ensures that your personnel can consistently and accurately meet requirements resulting in correct outcomes and quality work.
This webinar will discuss the structure of the PSMF as per EU Directive 2010/84/EU and how adopting this document in the US will provide a transparent process for Accountability, Inspection Preparation and Business Analytics.
This 90-minute webinar will help you gain an understanding of the regulatory background and provide complete guidance starting from the planning and writing requirement specifications to vendor evaluation, installation and operational qualification and continued testing while in routine use. The webinar also covers the instrument qualification and system validation processes.
This FDA inspection webinar will show you what it means to be “Inspection Ready” and how a Quality System in place at your company will ensure ongoing quality measures to be ready at any time for an audit, review by a Sponsor or any regulatory agency inspection.
In this prescription drug pricing webinar attendees will the key components of the trump administration on drug pricing plan, elements of the white house drug pricing blueprint and the federal policy outlook for U.S. drug pricing in 2019 and beyond.
This webinar will provide a general overview of the cell-based methods using process controls as well as specific examples of successful monitoring of cell-based methods leading to reduced assay failures.
This Utilization and Denial Management webinar will assist the case management department leader and RN case manager in understanding the role of utilization management in a busy case management department. Determining the optimal model for ensuring the best approach to making sure that all cases are billed appropriately and timely is essential. This webinar will discuss two models, as well as the new concept of artificial intelligence that can be utilized as an adjunct to the medical necessity process.
In this medical devices security webinar you will learn how to establish a Product Security Program that help your organization to put the right people, processes, and technology in one place to solve the changing landscape of connected medical devices and the risks that are associated with the new environment.
It will also highlight the medical device security leading best practices the industry has been implementing to not only meet regulatory requirements but also increasing customer’s needs.
In this food safety webinar attendees will learn how to set up a robust allergen control plan with latest approaches for cleaning, validation, monitoring and preventative controls required under FSMA (Food Safety Modernization Act). Also attendees will learn insights for testing, laboratory review and cleaning practices to improve or review their allergen management program.
This webinar will help attendees to understand the quality issues and methodologies that are relevant in current supply chain management to improve your customer satisfaction.
The purpose of this facilities management training course is to present the regulations in a clear and concise manner in order to provide participants with the necessary information required to maintain the safety and efficacy of drug products.
