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 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).
Companies engaged in the conduct of human clinical trials must adhere to specific government regulatory requirements. Certain documents, content and images related to a clinical trial must be stored and maintained, and depending on the regulatory jurisdiction, this body of information may be stored in a trial master file (TMF). All of the data and documents supporting the planning, conduct and evaluation of a clinical trial must be of the highest integrity, which must be maintained through their entire life cycle. Computer System Validation will be discussed as a key methodology for meeting all of these requirements and assuring data/document integrity.
In today's rapidly evolving scientific landscape, the 90-minute webinar titled "Human Error and Documentation Practices in Good Laboratory Practices (GLP)" offers an essential exploration of the critical role that accurate and complete documentation plays in maintaining the integrity of research processes. Delving into the heart of Good Laboratory Practices (GLP), this enlightening session uncovers the intricate relationship between meticulous documentation and the reliability of scientific findings. Over the course of the webinar, attendees will gain a comprehensive understanding of the multifaceted challenges posed by human errors within laboratory environments. With real-world examples, the webinar illustrates the potential consequences of inadequate documentation, underscoring the significance of precise record-keeping in safeguarding data integrity, research reproducibility, and regulatory compliance. Attendees will also glean valuable insights into common documentation errors and pitfalls, as well as invaluable strategies for bolstering documentation practices. From proactive measures and standardized procedures to fostering a culture of clarity and collaboration, participants will leave equipped with the tools to elevate their documentation practices and contribute to the overall credibility of their scientific endeavors.
This 510K webinar will review the proposed changes currently being discussed regarding the 510K program and how these changes will likely impact the medical device industry in the future.
This Laboratory compliance training will review the regulations that cover each environment and present simple and effective strategies for satisfying the requirements.
The Objective of this live, interactive training webinar is to explore the various issues surrounding the history of B. cepacia and its Complex and examine solutions to common microbiological problems. It will discuss the General Chapter USP<60> which was issued December 2019, media that is used, as well as consider recalls, FDA 483s and Warning Letters. The webinar will also review why 16S rRNA identification will not work satisfactorily with this Complex. Please plan to bring an interdisciplinary team to this Webinar to explore how knowledge regarding this contaminant may assist you in your facilities and minimize it as an Objectionable microorganism.
In this webinar, learn about the several regulatory requirements sponsors need to comply with for the development of the drug product. These requirements expand to include interaction with other regulatory agencies, both Federal and State. The post-marketing obligations encompass more functional areas of the company; including sales and marketing, medical affairs, and external spokespersons.
