In this analytical method transfer webinar attendees will learn the options available for the transfer of validated, non-compendial methods to a different site. In addition to current regulatory guidance, the different options for method transfer will be discussed. The webinar will set out an efficient, risk-based approach that reduces effort whilst meeting the requirements of regulators.
21st century business organizations require active and engaged risk management activities. Today's risk and compliance process is rather complex and dynamic, therefore it requires governance, risk and compliance professionals to possess certain skills in order to effectively complete their duties and responsibilities. The days of using staid audit programs are over. This training program will engage participants in evaluating each business process using a risk-based approach and in preparing risk and compliance documentation for each engagement.
This webinar will discuss setting up statistically justified sampling plans for process validation. Discussion will also involve using the sampling plan to set acceptance criteria for process validation. Setting acceptance criteria for test method validation will also be presented.
Recent updates to the Nacha Operating Rules were developed to enhance the ACH “user” experience with improvements and simplification by adopting new technologies and channels for the authorization and initiation of ACH payments. Included in the change was a reduction to the barriers when using the ACH Network by providing clarity and increasing consistency pertaining to certain ACH authorization processes and by reducing some of the administrative burdens related to ACH authorizations.
What does all this mean will be covered in this 90-minute webinar, explaining how this new Rule applies (and it is optional for Originator/ODFI).
This IRS regulatory compliance training will explain the TIN Matching System best practices to eliminate form 1099 reporting errors. It will also provide you the tools to effectively handle B- Notices in order to avoid fines and penalties.
This training program will examine how human factors/usability is the analysis of how people interact with medical devices. The process of conducting rigorous human factors studies throughout the design process, integrating it with the device risk analysis and design process, and validating the effectiveness of the studies will be explained. The various types and methods of human factors analysis will be explained. This process conforms to the new ISO 62366 standard and the new FDA guidance document.
This webinar will provide participants with a comprehensive understanding of the Americans with Disabilities Act and will explain the importance of compliance and the consequences of non-compliance. Participants will gain a solid understanding of the ADA’s disability accommodation process and the interactions between Federal and State laws.
In this training program attendees will learn the key elements needed to develop a proactive Regulatory Compliance Written Program. After this webinar, you will have confidence in facing the next EPA regulatory compliance audit that comes your way.
This training will evaluate the chief areas of an FDA cGMP compliance audit and help you understand the actual and anticipated changes in emphasis based on this new regulatory climate. It will prepare you and your company for tougher US FDA cGMP compliance audits.
This webinar will discuss dealing with supplier change notices. Regulatory agencies have the expectation that a manufacturer has control over its supply chain and dealing with changes to that supply chain can be challenging.
This training program will enumerate the requirements of the Emergency Planning and Community Right-to-Know Act (EPCRA) as it applies to your organization. It will also help attendees understand the threshold trigger for reporting a hazardous chemical on the Tier II forms and learn how to accurately calculate chemical mixtures as it applies to the Tier II forms. Further, attendees will learn to navigate the complexities of online Tier II reporting.
This 90-minute webinar will show how you can implement a closed-loop CAPA system that meets CGMP requirements and U.S. FDA expectations. You will learn simple, but powerful, tools and methods that you can use regularly and systematically to define and resolve root causes, not just symptoms.
This webinar will discuss the process of becoming a Canadian Non Resident Importer. Attendees will learn how to attain business registration number, HS tariff classification and tariff treatment, process of claiming GST on imported goods, ways to complete the Canada customs invoice and more.
This training program will take attendees through the actions to take when confronted with an active shooter and in assisting responding law enforcement officials. It will help recognize potential workplace violence indicators and describe actions to take to prevent and explore the General Duty Clause of the OSH Act.
This webinar will help you identify factors that cause delays as patients progress through their stay and how to correct these barriers to care. Learn the most streamlined ways in which to integrate avoidable delay management into your day and with all the members of the interdisciplinary care team. Finally, it will review some examples of report cars that can be used to understand the data you have collected.
This project management training for FDA regulated companies will show how you can meet key FDA and EU MDD regulatory requirements for the project you manage. It will focus on proven tools and techniques for successful development and implementation of project management planning.
In this Regulatory Audit training participants will gain an understanding of how to prepare for and audit, strategies to conduct and support a successful audit, and ways to respond to audit observations. Special consideration will be given to virtual audits as a result of the Covid-19 Pandemic.
FDA regulates advertising and promotion material as labeling. The legal definition of labeling covers just about anything that explicitly or implicitly conveys a message intended to affect a person’s behavior and decision outcomes. How FDA applies its legal tenants of false and misleading information or variations on that theme requires continual updating by FDA and constant re-evaluation by industry. Now the regulatory landscape involves other federal agencies and academic principles in psychology. It has become very complicated and will prove very costly if you knowingly or unknowing walk into one of FDA’s legal snares. This webinar will bring attendees up to speed so you are clearer about what is a problem, what is not a problem and what becomes a risk laden judgment call.
This webinar training will discuss the recent updates in OSHA Recordkeeping and Reporting Requirements. Speaker will explain the major regulatory changes that went into effect January 1, 2015
Participants will gain valuable understanding of 300, 300A and 301 log, new reporting timeline requirements and exemptions.