Compliance Training Webinars for Regulated Industries

This FDA compliant SOPs training will explain how to write, organize, and maintain Standard Operating Procedures (SOPs) and train personnel so that you can ensure FDA compliance in a way that is concise, reproducible and easy to follow.

This training program will highlight key differences between SDTM and ADaM models and process flows. It will also focus on key differences between the seven CDISC classes and on best practices to create Dataset.XML from SAS. Attendees will gain a better understanding of the structure and syntax of ODM-XML files as well.

This 2-hr virtual seminar will show how OSHA analyzes record-keeping scenarios, applying the recordkeeping regulations, Frequently Asked Questions, and Interpretation Letters.

The webinar will cover what employers need to know about the workers’ compensation premium audit. Experience shows that more than 75 percent of premium audits are incorrect, most often to the detriment of the employer. At the end of the webinar, attendees will be armed with the knowledge they need to ensure that they pay only what exactly they owe for their workers’ compensation and not a penny more.

In this training program, attendees will learn quick formatting tips that will make writing more readable and learn how to use formatting tools in a way to maximize the impact of their writing in an electronic system.

This training program will illustrate why it’s essential to understand FDA regulations and OTC labeling requirements to market OTC drugs in the U.S.

This webinar on avoiding serious FDA 483s will explain FDA's changed audit focus based on recent top 483 findings and provide practical tips on how to better prepare your company's internal audit program to avoid serious Form 483 observations.

This Medical device training will acquaint one with the various terms used in risk management and the importance of ISO 14971 & ISO 13485 in the managements of risks during the life cycle of medical devices starting with design and manufacture.

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.

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 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 training on Foreign Accounts Tax Compliance Act will teach the attendees best practices to ensure compliance with FATCA. Learn how to comply with your withholding and reporting obligations.

This training program will explore the operational implications of dealing with heightened-risk categories such as PEP screening at the heels of the Panama Papers controversy. The program will also discuss the current changes in the marketplace and expose the new faces of AML and examine areas of PEP regulation that pose present and future challenges for regulated businesses.

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 webinar will explain how to apply the theory of lean documents and its corollary theory of lean configuration to present a fresh approach to controlled document system for a life sciences manufacturing plant.

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.