Compliance Training Webinars for Regulated Industries

This training program on applicable regulations pertaining to clean room environmental monitoring (EM) programs will discuss the basics of setting a robust and effective EM program. The course will also detail the relationship between an EM Excursion Program and CAPA and the four phases of clean room transitional monitoring.

This training program will discuss in detail the CMS requirements for hospitals to help prevent the hospital from being found out of compliance with the grievance regulations. It will also cover a new law under the OCR Section 1557 which requires the hospital to have a new process for handling discrimination complaints.

Cloud computing has become perhaps the most critical compliance topic related to computer validation and electronic records. The potential economic and resource advantages to using cloud based environments guarantee that management will expect compliance strategies to be developed that will support decisions to utilize cloud environments to perform regulated activities. This presentation will provide a baseline of information related to cloud computing which will help attendees better understand the cloud concept, associated regulatory challenges, and suggestions for consideration when establishing a cloud based system.

This training program on Latin America import and export will detail the US requirements to export and import procedures to Latin America. It will also discuss commercial and customs document requirements, tariffs and applicable duties, countervailing and antidumping duties, and highlight the difference between automatic and non-automatic import licenses.

This training program will focus on regulations that apply to most goods imported into the United States and illustrate them with examples. In addition, attendees will learn more about country of origin marking for exports from the United States to other countries.

This training program will discuss CDISC requirements to create SDTMs and ADaMs. It will also offer essential mapping and strategy concepts for creating and validating SDTM and ADaM variables in key CDISC datasets (DM, AE, ADSL, and ADAE).

This webinar will discuss FDA requirements for clinical trial Computer System Validation (CSV) including System Development Life Cycle (SDLC) approach to validation. It will help attendees understand how to leverage the vendor and other external resources to apply the best industry practices and avoid potential pitfalls when validating a clinical trial system.

This webinar will teach you how bundled payments actually work as they move from demonstration to reality. It will discuss how case management must become a fully integrated across the continuum model.

This training program will focus on defining and explaining numerous concepts and terminologies in a simple language as related to the safety, efficacy and quality assessment of pharmaceutical products for human use. It will also describe the necessity of understanding the basic physiological concepts pertinent to drug actions, product developments and evaluations.

In this webinar attendees will learn the key issues and sample requirements (collection methods, sample inhibition and sample volume) for molecular diagnostics and the tools (PCR, DNA fluorescent assays & NGS assays) you need to deal with your laboratory challenges in clinical laboratory.

This training on OIG Self-Disclosure Protocol will help the attendees on the revised self-disclosure protocol (SDP), the process and procedures for self-reporting and the risks of not self-reporting. It will also review the need for the organization to be aware of excluded entities.

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.

This validation training program will discuss regulatory requirements from the FDA, EU and ICH perspective, review all the detailed guidance on the concepts found in ASTM E2500 to help industry professionals understand how to implement a validation program based on the ASTM 2500 Approach.

In this webinar attendees will learn about FDA’s regulatory expectations for classifying, assessing the risk, testing, and validating a computer system used in FDA-regulated work. Also attendees will learn in detail about the System Development Life Cycle (SDLC) methodology used to approach Computer System Validation (CSV), including all of the phases, sequencing of events, deliverables, and documentation requirements.

This webinar training program will discuss how to develop an accident investigation plan, manage cost, and develop realistic schedule. Participants will learn about the interview process, protecting site of incident, determining root cause, and avoidance plan.

This training program will focus on how cell cultures are used for in vitro assays. It will include examples of cell based assay systems and list the advantages of cell based assays. The webinar will help attendees understand the uses of in vitro testing with eukaryotic cell based systems, the parameters to be considered in the development and optimization of a cell based assay and the validation of a cell based assay.

This training program will discuss various aspects of the IRS Form W-2 for 2019. The webinar will cover requirements for completing and filing the form including a box by box explanation. Best practices for completing and reconciling the form, and handling duplicate requests from employees will also be covered. The webinar training will further look at when to use the correction Form W-2c and the latest requirements for the Affordable Health Care Act as it relates to reporting requirements on the form.

The objective of this 60 minute webinar is to help exporters and importers understand Letter of Credit terms and conditions that go into structuring a transaction for successful payment and receipt of goods. Attendees will learn how to use Letters of Credit to assure payment for exports, how to apply for a Letter of Credit and what terms and conditions should be used for successful transactions.

This program provides the attendee with concrete and implementable strategies for integrating and embedding case management across the continuum of care.

This CBP audit preparation training program will help attendees move toward a systematic approach for both general compliance and when notified about a CBP audit. It will help identify the likelihood of being subject to CBP audits, and help spot potential vulnerabilities and test your compliance (potential vulnerability, self review and general audit issues).