Compliance Training Webinars for Regulated Industries

This training program will discuss changes from ISO 13485: 2003 to ISO 13485: 2016. Attendees will learn how to apply additional supplier controls and understand how improvement and corrective action clauses are strengthened.

This webinar will review the various elements of the physician employment agreement, focusing on the pitfalls and the problems that can develop when the agreement does not clearly define the relationship, and/or when the parties do not fully understand what is being agreed to. Such items as term and termination, termination for cause, duties of the physician, call, non-compete, and compensation are all items that should be clearly set out in the agreement and fully understood by the parties.

This online training will discuss the concept of Clean Labelling. Attendees will learn how to identify the approaches to meet consumer demand without compromising functionality, safety, shelf-stability, ethics and regulation.

This training program will discuss the requirements of ICH and the FDA for stability protocol content and format, including special stability studies required for approval.

The Equal Employment Opportunity Commission and the Office of Federal Contract Compliance Programs are stepping up their game and focusing on pay disparities as a form of employment discrimination. This training program will offer attendees an understanding of Title VII, sex discrimination and pay equity to help employers get ahead of the EEOC/OFCCP’s new priority and avert pay discrimination claims.

This webinar will cover creating of a value-added an internal and supplier auditing program for compliance to FDA and ISO 13485 internal auditing requirements. It will include how to set up and manage the auditing system, as well as how to conduct audits, and document the results and any nonconformities. It will discuss the value of a good auditing program.

Medical device manufacturers need systems to implement regulatory requirements (meeting customer requirements and handling regulatory complaints) as well as a business processes to determine customer satisfaction. While the three systems are related, each serves a different purpose. You will learn how to implement a customer satisfaction process to complete theses three important aspects.

When exporting outside the U.S., exporters must consider the Food and Drug Administration (FDA) provisions as it helps them understand what documents and procedures are needed in coordination with the transaction process. This training program will provide an in-depth explanation of FDA-regulated products that are exported from the United States to foreign countries. Also, it will address what export documentation must be used in the transportation of FDA-regulated products.

This 2.5 hours training will review the key elements of the new food regulations in Canada, the United States and the international marketplace. Get accustomed to new regulatory expectations and be prepared to develop relevant and productive compliance plans.

By attending this webinar, you will gain a better understanding of the regulatory expectations for an effective and GMP-compliant training system. In this webinar your instructor will share with you what he has learned over the past decade of developing and delivering effective GMP training programs as well as from his 25 plus years of working in the Life Science industries.

This training will review Office of Foreign Assets Control (OFAC) and the US Department of Commerce, Bureau of Industry and Security (BIS) respectively amended; the Cuban Assets Control Regulations (CACR) and the Export Administration Regulations (EAR) to further ease the US embargo against Cuba and authorize certain business activities with Cuba in targeted sectors.

The presentation is tailored for those corporate leaders and employees of DEA registered manufacturers responsible for handling Schedules I through V controlled substances and List I regulated chemical products. This training will cover several recommendations to improve your methods of record-keeping required of DEA registrants.

This webinar will explain how to design and administer HIPAA monitoring and auditing programs to meet HIPAA requirements. This session will cover some of the most common exceptions under the Privacy Rule and include practical tips for demonstrating good faith compliance efforts. In addition, there will be discussion of next-generation technologies that can help covered entities and business associates detect and report inappropriate accesses and disclosures of electronic protected health information.

FDA, in November 2016, issued a Guidance explaining and clarifying the existing MDR regulation. Many of the details of the MDR regulation were unclear and ambiguous and resulted in nonconformances. This new Guidance attempts to eliminate confusion.

Section 1557 of the Affordable Care Act (ACA) forbids discrimination based on sex, race, color, national origin, age and disability. It builds on longstanding and familiar federal civil rights laws but is the first law to prohibit discrimination on the basis of sex (which includes gender, gender identity and sex stereotyping) in covered health programs and activities. Sex discrimination also includes discriminatory treatment on the basis of pregnancy, false pregnancy, termination of pregnancy, recovering from pregnancy, childbirth and related medical conditions, sex stereotyping, and gender identity.

This 90-minute training program is designed for people tasked with performing external audits for their organizations. It is also for those tasked with developing, maintaining and/or improving programs for manufacturing facilities. This includes individuals that have quality management system responsibilities for making general improvements in their organization’s performance specifically related to equipment, processes and documentation.

This training program will illustrate five effective personal actions to enhance a safer workplace and describe the four different phases of the safety maturity curve. It will explain the four most common deflections of a safe workplace and how to minimize their impact.

This training program will discuss the history of US Customs, including the US Customs Modernization Act (Mod Act). It will also detail the roles and responsibilities of customs versus the importer.

This webinar will discuss 4 key payroll practices that will be crucial to the department in 2017. These practices will increase efficiency, cut costs, prevent fines and penalties for errors and help the department identify areas to focus on for improvement in 2017 and beyond. The training session will address other payroll essentials such as why it isn’t just Forms W-2 that are being scrutinized by the IRS - it is also fringe benefits and all tax practices.