Compliance Training Webinars for Regulated Industries

In this 510(k) submission process webinar attendees will learn the different types of 510(k)s, 21 required elements in the traditional 510(k) and how are they addressed and documented. Also attendees will learn software / firmware requirements, De Novo submission for obtaining marketing clearance for medical devices in the U.S.

This training on Japanese regulatory compliance requirements will explain the country's regulations and processes (including clinical trials, filings, etc.) and use real world experiences to show how compliance issues are culturally handled for life science products in Japan.

Annex 1 is a European mandate for Sterile Products Manufacturing but encompasses many critical utilities including pharmaceutical water. The current version is under revision and may be contrary to some Pharmacopeias. Annex 1 will be enforced by PIC/S, EMEA, and other European regulators. This is a very important subject to anyone manufacturing products either in or for the European market.

This webinar provides some practical and useful answers to the question "What Kind of Statistical Methods and Tools Does the FDA Want Pharma to Use?"

FDA’s guidances and regulations have emphasized the use of statistics for many years. Statistical thinking and methods is an integral part of the Jan 2011 FDA Process Validation Guidance. It can be argued that the FDA is looking for the pharma and biotech industries to make even greater use of statistical thinking and methods. Even with this long history, the use of statistics seems to be a source of uncertainty and anxiety for many. This presentation provides an overview of what it appears the FDA is looking for in the use statistics including examples and recommended approaches.

This training will identify the top habits of highly successful HR Departments as well as what happens if these elements are corrupted or missing.

This session will give rise to the participant’s understanding of how goal setting works and how it can be used in a management context. We will also discuss how to track goals for maximum efficiency and other webinars in this series will use the goal setting methodology as a foundation. The webinar will provide a brief description of the definition of SUCCESS and how the scientific goal setting process fits into that definition.

Employers, HR professionals and Leaders are desperate for guidance when it comes to decisions made in the workplace to accommodate our "New Normal" and to adhere to compliance regulations during the COVID-19 Pandemic. When you have different Federal and State requirements regarding the health guidelines and mandates which is critical but, what happens to the workforce?

How should employers change to accommodate the "New Normal" for employees? How should employees be paid when they work remotely, how should employees be laid off (if it comes to that), how should employees be deployed effectively, who should stay on site during the state 25%-30% reduction in the workforce on-site, how to conduct social distancing, the everchanging communications it is not a wonder that we need to ensure our employees and even customers are aware how we will guide them and ourselves to ensure we are providing the necessary leadership to manage this crisis.

The new medical device regulation EU MDR 745/2017 in the European Union has a lot of new requirements. One hot topic is the focus on the "Post-Market- Surveillance-Process" and the new requirements e.g. reporting to Competent Authorities and Notified Bodies and how this process is connected to other processes in the quality management system according to ISO 13485:2016. The understanding of these changes and how to implement changes until May 2021 is essential to keep your certificates and to keep the market entry open.

Attend this webinar to understand the key requirements for risk management of clinical trials to comply with the latest focus on GCP inspection in this area including during the challenging environment of COVID-19.

This webinar will discuss and define GXP’s, where the variable “x”, is Laboratory, Clinical, or Manufacturing. The webinar will focus on the requirements for each, and how they relate to the total product lifecycle, compliance, and inspections.

HACCP Hazard Analysis and Critical Control Points is a management system in which product safety is addressed through the analysis and control of biological, chemical, and physical hazards from raw material production, procurement and handling, to manufacturing, distribution and consumption of the finished product. HACCP is aimed at prevention of contamination, instead of end-product evaluation.

Importing FDA regulated product faces new challenges, new risk management procedures, and mitigation of business consequences that will affect corporate profits. Basic issues should be evaluated and updated to help you plan for unprecedented problems and your helplessness to escape the trauma. The COVID-19 creates a global bondage on commerce and drains, if not dries up, the supply of necessary products to protect the health and well fare of your customer base, which actually is the entire U.S. population. In this webinar, you will mentally travel through your import process, how it will or can be derailed and identify issues you need to evaluate during the current interruption of your standard import business.

This session focuses on the issues of managing release health information when it may involve substance use disorder treatment information. We will explain how HIPAA relates to information management and release and explain the processes required for various releases of information under the HIPAA rules, including release according to individual access requests, and under consents and HIPAA authorizations.

Preclinical development is a critical stage of drug development that determines as well as measures the “therapeutic” doses needed and the ability to achieve these doses. Moreover, preclinical studies assess the safety of the drug at these doses.

This webinar is designed to help companies develop cost effective and sustainable safety management strategies. Topics covered include; management responsibility, worker engagement, continuous improvement, consensus standards and how to move from second class to world class.

Artificial intelligence (AI) has become a strategy to turn smart tasks into game-changing tools and technologies for healthcare providers. This has been documented in the processes of coding, diagnosing some diseases, and has assisted financial teams in identifying outcomes that would have all taken many hours by staff performing these tasks. Coupled with the right expertise, AI has been shown to be effective in case management departments, as well-especially with the utilization management process.

Lots of energy are being spent on ensuring that IT systems in financial institutions are 'safe' or can be declared as such to the public. However, we have to observe a gap between what needs to be told and the cyber-risks that are actually incurred by financial institutions. In this webinar, we keep away from the technical considerations which, as useful as these may be, inevitable end up in the dead-end when confidentiality has to be alleged. Instead, we challenge where the approach may err: when cyber-security teams have to keep their specialist knowledge to themselves instead of enrolling the other functions of the bank into a cyber-security systemic approach which can cover cyber-risks whatever their sources and natures: from organized crime to internal negligence, and including reputational risks.

The new medical device regulation EU MDR 745/2017 in the European Union has a lot of new requirements. One of those requirements is Article 15 Responsible Person for Regulatory Compliance. That role is a little bit similar to the role of the Qualified Person in the Pharma Industry but not the same and the new role is not the same as the Quality Representative for the quality management system. Your company must implement the new role in the organization structure and in the processes and take care of the qualification requirements.

This webinar will discuss how to most effectively and efficiently comply with the complex maze of FinCEN rules and regulations for MSBs (Money Service Business). Compliance does not have to be onerous and time-consuming. Discover tools and techniques that can simplify your processes while minimizing regulatory scrutiny.