Compliance Training Webinars for Regulated Industries

This training program will discuss the concept and application of uncertainty of measurement (MU) as required by ISO/IEC Standard 17025:2005 for laboratory accreditation, from a practical microbiological perspective, using unambiguous language and useful examples.

This training program will offer attendees an understanding of human error, its factors and causes. The program will also identify the regulatory and business importance of human error prevention and define the process to manage human error deviations.

This 60-minute webinar will help exporters understand International Commercial Terms, or INCOTERMs, published by the International Chamber of Commerce and how to select the correct one for their transactions.

This webinar will review the regulatory requirements for investigating an OOS Investigation. The responsibilities of the analyst, the supervisor and QA will be discussed. A detailed flow chart will be used to help the attendees clearly understand the steps and the order in which they are to be performed. The structure of an Investigation report which properly documents the investigation will be discussed.

This webinar will discuss the latest global medical device design controls requirements for software in a medical device (SiMD) and software as a medical device (SaMD). Each requirement pulled from U.S. and global standards and guidance (e.g. IEC 62304, IEC 82304, IMDRF SaMD Guidance, AAMI TIR45) will be explored to fashion a complete picture of activities, document content, and dependencies across a variety of lifecycle development models. The session will also include special topics such as evolving cybersecurity requirements, the relationship of software design controls to non-medical device applications, and proposed regulatory frameworks for AI/ML systems.

This training program will be beneficial to personnel directly involved in the development of cleaning procedures, cleaning validation programs and plans. Additionally, those responsible for cleaning validation protocols and execution activities, including validation and laboratory personnel, as well as, beginning or seasoned operational personnel who will eventually participate in such efforts, will find this course particularly useful.

The meanings and regulatory requirements of the terms “verification” and “validation” are often confusing to engineers and even some regulatory professionals. FDA regulations as well as European standards such as ISO 13485:2003 require both verification & validation documentation throughout these regulations and standards. The terms apply to design control, process control and others. This presentation will define and explain the differences (& similarities) in these terms and how they apply to regulated industries as well as the consequences of poor adherence.

Discrimination continues to be a problem in the workplace even with existing and developing regulations to train employees and managers against engaging in such behavior. The obligation to conduct a sound and thorough investigation by an appropriate investigator is mostly understood, but practitioners need to do that actual work. This course is designed to provide HR practitioners of all levels with a step-by-step process for conducting discrimination investigations in the work environment that will protect employees and the company as well.

ISO 14971:2019 is the definitive standard for risk management for medical devices and IVDs. The standard lays out a comprehensive approach to managing risks in the life sciences. The course will discuss practical approaches to complying with the standard.

This training will cover several recommendations to improve the hospital’s due diligence when administering and dispensing narcotic drugs in a hospital setting and what steps to take to detect and prevent the illicit use or diversion.

This course will cover validation essentials for medical device manufacturers. Attendees will learn about what processes needed to be validated and what steps you need to take to validate processes. You’ll learn the essentials of validation planning, protocol writing, and change management. We’ll cover the steps of Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) including tips and best practices.

This training will cover compliance requirements for running clinical trials in pediatrics, particularly in the EU to comply with the EU ethical considerations guidance for running clinical trials in pediatrics.

This webinar will explain legislative roles and responsibilities of workplace parties and how HR plays a pertinent role in it. Instructor will discuss OSHA regulations and safety compliance practices and how to create safety culture at workplace. He will share practical tips and best practices for HR managers taking the responsibility of safety regulatory compliance.

This webinar will provide understanding of FDA and ISO 13485 requirements for process validation and how to implement them.

Learn when and how you must compensate employees for travel time. Ensure you comply with the requirements under the Portal Act. Get an update on IRS travel expense documentation requirements. Learn about employer liability for accidents of traveling employees. Clearly define when employee meals are 100% deductible and when they are only 50% deductible. Understand the limitations when personal and business travel and entertainment are mixed. Ensure your records will stand the scrutiny of a compensation or tax audit.

Dr. Davis describes important directions and core principles of selected frameworks. He also links these guidelines and principles to relevant practices. The principles outlined in this session reflect ISACA defined governance system themes: (1) meeting stakeholder needs (2) enterprise end-to-end coverage, (3) organizational customization (4) dynamic homeostasis, (5) enabling a holistic approach, and (6) separating governance from management.

This 60-minute webinar will help exporters understand International Commercial Terms, or (INCOTERM) Any company that imports or exports goods internationally needs to know which International Commercial Term (INCOTERM) to use for each shipment.

The objective of this webinar is to compare and contrast between Good Laboratory Practices and Good Manufacturing practices.

OSHA penalties have increased continuously for over 5 consecutive years! The new penalties took effect August 2, 2016. Any citations issued by OSHA on or after this date will be subject to the new penalties if the related violations occurred after November 2, 2015.

This webinar will provide you the information you need to create supplier quality agreements (QA Agreements) with key suppliers and to understand which of your suppliers should have these agreements to meet expectations of the FDA and ISO 13485 Notified Body auditors.