Compliance Training Webinars for Regulated Industries

This webinar will help attendees understand differences between GMP requirements for early and later stage clinical development. It will explore and discuss ways to develop and implement strategies for early GMPs for phase I clinical studies.

Many companies offer their devices in the EU, so must comply with the EU UDI regulations. There are significant differences from the US system. While some details remain, there is sufficient information to allow companies to start planning. This webinar can help you prepare for this major aspect of the new EU regulations.

Cardiology Coding 2017, mid-year update. We will cover in office diagnostics, to include any updated rules on EKGs, Holters, Stress Tests. Look at the new coding for 2017 Moderate Sedation Codes, and how they have impacted the first half of 2017. This webinar will also discuss on the new E/M symbols, rules, and new codes and deleted symbols that will impact provider reimbursement, for Cardiology services.

The food label is one of the most important tools Canadian consumers can use to make informed choices about healthy and safe foods. Canadian food legislation has specific requirements for food manufacturers regarding what to include on a food label and how it should be presented. This course will review the basic requirements of the Canadian Food label, including requirements for the location and size of the common name, net quantity declaration, list of ingredients and allergen labeling, identity and principal place of business, date markings, nutritional labeling, bilingual requirements, irradiation, and sweeteners. For manufacturers of food products for consumption in Canada wishing to ensure compliance to the latest nutritional labeling standard, this course offers an overview of the necessary elements to ensure compliance.

This Food Safety and Quality Management training will provide guidance on methods for conducting effective incident tracking. Attendees will learn how to analyze and utilize incident tracing information and data to the benefit of your food business.

This training will discuss the final guidance on postmarket management of cybersecurity in medical devices which was released in Dec. 2016. Attendees will learn how to establish a risk-based framework for assessing when changes to medical devices for cybersecurity vulnerabilities require reporting to the FDA.

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.