Compliance Training Webinars for Regulated Industries

This webinar will discuss ways to develop rewards and deterrence strategy to ensure staff are effectively motivated to comply with the firm’s policies & procedures. It’s often a matter of clarifying for staff what is expected of them to tailor their job, and how best they can satisfy compliance requirements without compromising their own performance. The goal is to turn this into a crusade without staff believing it to be so.

If you develop or manufacture a product regulated by FDA you will need to interact with FDA employees. It is important to interact with the FDA employee in the most productive manner. But there is a variable you must deal with that will determine how productive your interaction is. The variable is the FDA employee. That is the purpose of this webinar.

This course provides insights and best practices for both candidates and interviewer(s) for conducting remote job interviews. Covid-19 has greatly enhanced the need for remote interviews but even prior to and after social distancing guidelines subside, there are numerous circumstances when remote interviews are appropriate.

This ISO 27001 webinar will help you to audit your program in relation to establishing, implementing, operating, monitoring, reviewing, maintaining and improving an information security management system and we will also discuss which standards to reference to effectively ensure your organization has a robust security program for your organization's vital information assets.

This international trade compliance training program will evaluate strategies such as drawback, foreign trade zones or free trade agreements. It will also offer guidance and best practice strategies for several import/export practices such as methodology for measuring trade compliance score, and determining export control classification number.

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 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.

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.

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.

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.

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.

Change does not have to be hard and in the course of thes webinar we will explore the causes of change in this VUCA age we are in. We will also look at the difference between a stakeholder and a shareholder and their impact on change. Along with the strategies to handle change we will also look at the various stools available to guide you along the way.

USMCA addresses recent and critical emerging issues, such as harmonization of regulatory systems, e-commerce, rules of origin, protection of intellectual property, and dispute resolution. These changes in USMCA will affect your operations and therefore, it is critical to understanding the key differences between NAFTA and the USMCA.

Accelerated assessment of medicines in the EMA’s centralised procedure may be granted for treatments that are of major interest to public health. It is one of a number of regulatory mechanisms designed to provide early access to new drug treatments.

Attend this webinar to get Step by step instructions on creating your department’s strategy utilizing agile principles. It will cover a Simple straight forward process you and your team can execute with ease. We start with a 360 degree analysis of your stakeholders, high light priorities, align to the larger organization goals, identify risks and roadblocks, create meaningful measurements, and develop the 2020 roadmap.