Compliance Training Webinars for Regulated Industries

Validation is an important element of the Quality System Regulations and ISO13485. This course will cover the validation essentials for medical device manufacturers. You will learn about what processes needed to be validated and what steps you need to take to validate processes. Validation is a powerful tool in understanding, optimizing, and controlling manufacturing processes. We will cover the essential steps of Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) including tips and best practices.

This case management webinar will explore how an initial assessment and clinical review can better ensure that patient is placed in the correct setting right from the get-go which is a very unique role played by ED and admitting office, transfer center case managers and social workers. The 2 midnight rule and the part that case management plays in managing it will also be reviewed. It will give idea about reducing the use of Condition Code 44 or self-denials when patients get admitted to the incorrect level.

This GLP quality system webinar provides a general overview of the Proposed Rule, a GLP QMS and its implementation, GAP analysis, Plan-Do-Check-Act cycle, process control and optimization theory and quality audits are utilized for the analysis of an existing QMS and the potential benefits, barriers steps to implementing an optimized GLP QMS.

cGMP compliance for dietary supplements is mandated by FDA regulation 21 CFR part 111, which stipulates that anybody who produces, packages, labels, or holds a dietary supplement must create and implement current Good Manufacturing Practices (cGMPs) to ensure the supplement's quality. An FDA inspection is always imminent in a regulated industry. Their causes vary from receiving unknown SAERs to a scheduled visit. Regardless of the cause, the result is the same: THE FDA IS COMING.

This webinar will discuss federal laws on administering and dispensing veterinary medicine, penalties for non-compliance, DEA required records and effective methods to prevent unauthorized use of controlled substances.

This webinar seeks to provide a solid foundation to all parties involved in foreign exchange activities whether at executive, marketing, audit or operational levels into how the actual trading processes work, what the risks are and how these can be mitigated by using clearly defined standards of best practice.

Design Control is considered a critical process by the FDA. Yet is still a common source of 483 and Warning Letter observations. Most importantly, Design Control is critical to product quality, ensuring safe and effective products for your customers. This 90-minute webinar will cover the essentials of design controls for medical devices.

Environmental, Social, and Governance (ESG) has gained increasing attention over the past few years. Today many institutional investors will only invest in those companies that provide ESG performance reporting. ESG provides a set of standards for a company’s operations that today’s socially conscious investors use to screen potential investments in terms of how a company treats the environment, manages social issues (relationships with employees, suppliers, customers, and the communities where it operates), and deals with governance issues.

ANSI/AAMI/IEC 62304 is a Recognized Consensus Standard by the US FDA and a harmonized standard in the EU. This means that compliance to it provides a presumption of conformity to the requirements within those jurisdictions. Not complying with the standard has shown to lead to longer regulatory review times and frequent rejections.

This training program will provide participants with a working knowledge of supplier audits. The why, when, who, how, and what of conducting a supplier audit will be reviewed to ensure that your supplier can meet all your expectations.

Learn different HR metrics which can be used across organization to improve performance of human resources

This BSA/AML webinar will discuss various compliance requirements for AML - KYC, CTRs, SARs, new customer due-diligence process and various strategies which money launderers are using now and how to detect and thwart it.

Developing a QMS is a prerequisite for getting accredited. ISO/IEC 17020 sets out general criteria for the operation of various types of bodies performing inspection. ISO/IEC 17025 is the international standard for the General requirements for the competence of testing and calibration laboratories. Which is the right standard for you?

Strategically, tactically, and operationally sustaining information technology (IT) confidentiality translates into maintaining assigned information asset privacy levels. Organizations have failed in securing the privacy of personally identifiable information. In response, this presentation addresses information security issues regarding ISO/IEC 27701: 2019 standard integration considering the current organizational privacy protection practices.

This online training will offer an overview of what Health Canada considers to be a Natural Health product (NHP) and review Canadian regulatory requirements for Natural Health products. It will compare Canadian requirements with U.S. FDA requirements for marketing and labeling dietary supplements and convey an understanding of how they differ.

Tests of superiority, using null hypothesis statistical testing (NHST) are the norm in most research settings. However, there are situations where superiority of a treatment to a control is not needed, and sometimes it is not ethical to do so. For example, a researcher may be interested not in superiority, but instead, would like to compare the efficacy of a newer drug with a working treatment (an active control). In this webinar, Elaine Eisenbeisz will introduce types of statistical tests that can demonstrate that two treatments are ‘similar’ to each other in terms of their clinical effectiveness.

This training program will help attendees examine if their AP department matches world-class standards. Attendees will learn key success factors to an optimal Accounts payable operation. They will also gain in depth knowledge on the must-have technologies for any AP operation and learn how to design processes to fully leverage those capabilities. The webinar will also discuss balancing controls with efficiency and how to create a fraud-proof department. Attendees will learn about the most important metrics for any AP department and how to develop strategies to improve those metrics.

This training program will address the common human errors and deviations related to the use of procedures. It will also offer best practices for writing SOP’s to reduce the likelihood of human errors.

This webinar will discuss how root cause is an essential part of a corrective action system and will provide some examples of how to perform root cause analysis.

Skilled auditors require a method that aligns what they experienced during the reviewing process with what they compose during the writing process. This report writing workshop will provide foundation resources that participants can continually turn to during intense, complex audit engagements.