Compliance Training Webinars for Regulated Industries

This webinar will overview each critical aspect of the FDA submissions process to include 510(k) and PMA) and contrast those key steps to those of the EU Medical Device Directives Submissions process.

This webinar will give you the tools you need to maintain a quality supply of media and reagents in a variety of microbiology laboratories. A thorough understanding of the variety of challenges necessary in maintain quality media and reagents will be brought to the fore. This will allow you to perform microbiology testing with confidence.

This second training program in the series will review the structure of ISO 45001. It will discuss the mitigation process for the standard, the terminology associated with it, and its key requirements.

This webinar will provide the basic understanding of how to conduct a compliant and effective out-of-specification (OOS) result investigation which is critical in preventing product recalls, voluntary and involuntary plant shut down, and FDA 483 findings or warning letter. It will also provide a basic mainframe for the Quality Assurance unit in the final disposition of the affected finished product as well as provide guidance for the different types of OOS investigational systems.

This webinar training will discuss the lean principles and how to effectively implement them in your system to identify and reduce waste. The instructor will discuss how to apply lean to align business system and process with organisational goals so as to deliver rapid and measurable results.

This course will describe the basic principles and requirements for building a supplier audit program. This webinar will provide a framework on which to build your subcontractor auditing program.

In this session Mr. Wolfe will provide an overview of the Quality Payment Program, including its MIPS and Advanced APM pathways. This webinar will also provide a straight-forward, practical explanation of key provisions and options for clinicians and health care leaders as they navigate the 2017 transition year and beyond.

This training program will offer an overview of anti-discrimination laws and affirmative action issued for federal contractors; illegal and ill-advised interview questions; pre-employment tests (skills, strength, medical tests) use of social media, criminal background checks; and more.

This training program will discuss optimizing your packaging design for commercial and clinical products and translating a protocol into effective packaging design. Attendees will learn how to implement an effective artwork change management system. Real-life case studies and dos/don’ts for packaging and labeling for commercial and clinical products will also be discussed.

This webinar by a healthcare policy expert will provide insights on EMRs and E-Prescriptions, how they will be regulated, the pros and cons of each and their feasibilities.

With the overtime changes in New York State, this training program will discuss areas in New York State where the change will take effect. It will also discuss future changes to the rate and potential federal changes to the overtime rule.

In this interactive training session, attendees will obtain the latest and newest OSHA regulatory information and how it effects confined spaces at you construction site. The course will also help provide practical advice on how to implement practice contractor ‘vetting’ for hiring the best employees for your organization.

This European directive is very confusing for many and since it is European there are many in the US that need a clearer understanding of the directive. In this introductory webinar, attendees will be introduced to the important terms and concepts of the directive. Those who attend will obtain basic knowledge to understand what RoHS is about and if they need to learn more.

This webinar will offer a comprehensive, in-depth review of the state laws affecting the corporate governance standards applicable to insurance companies and the board of directors’ role in those standards.

This webinar discusses how to execute meaningful Method Transfers by selecting appropriate analytical performance characteristics and acceptance criteria, documentation of the transfer process and how to avoid failures.

This webinar will discuss FDA’s current recommendations on using electronic health records in prospective clinical investigations of human drugs, biologics, medical devices and combination products.

This training program will elucidate effective documentation techniques. It will discuss what documentation is needed to justify a termination decision and key record retention requirements. Attendees will learn how to fill out a performance appraisal and understand the essentials of a document retention program.

This presentation explores the basic concepts making up an ICH Q10 Quality System approach and steps to properly implement the concepts.

Maintaining order while managing long-distance teams and employees can often raise plenty of issues. This training program will help determine the fastest way to get a poorly performing location up to speed and offer attendees pointers on how to quickly and accurately check the quality of products or services at any location. It will also discuss ideal frequency for site visits, and best ways to approach a site problem without alienating anyone.

The Internet Crime Complaint Center (IC3) reports that U.S. victims alone lost $18 million in 15 months to just a single form of ransomware. This training program will review the risks associated with various types of cyber fraud, and in particular, business email compromise (BEC) and ransomware. The session will also discuss documenting sound business practices to minimize exposure and loss and list what to present to your board of directors before an incident.