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.
AI/ ML will revolutionize medicine by making diagnosis and treatment more accessible and more effective. FDA has regulated medical software by means of regulation and guidance for years, however, AI/ML programs fall outside the scope of these regulations and guidance. This happens because the FDA approves the final, validated version of the software. The point of AI/ML is to learn and update the following deployment to improve performance. Thus, the field version of the software is no longer the validated approved version.
New and Realistic Lean Manufacturing can be a key to company success, by incorporating basic lean principles, while addressing FDA / CGMP requirements.
This webinar is intended to provide guidance regarding the CGMPs on manufacturing methods utilizing the US FDA Production and Process Controls for Drugs and Devices and Statistical Process Controls (SPC) as taught by Drs. Demming and others and required also in the CGMPs and under control of variation process guidance.
This webinar will provide an in-depth review of enforcement actions taken by the HHS OIG over the previous two months. We will also briefly review the Anti-Kickback Statute (“AKS”), discuss any new safe harbors, and OIG Advisory Opinions that have been issued.
This webinar will provide valuable guidance to regulated companies in development and implementation of Design Control Planning and Techniques for new or heavily changed product development under 21 CFR 820.30, "Design Control", and ISO 13485 7.3. Also regulatory compliance proof of "progress against plan", and other activities requiring a planned documented rationale. It should be an important part of a company's IP (Intellectual Property).
