Compliance Training Webinars for Regulated Industries

This webinar compares the EU and FDA regulatory protocols to help individuals involved in manufacturing, customer service, quality assurance roles to streamline their understanding of the rapid and ongoing regulatory changes being adopted by all medical device regulatory bodies where manufacturers sell and manufacture their devices.

This webinar will review the compliance issues that most greatly impact on your practice such as the 2-midnight rule, the NOTICE Act, HINNs, and many others. It will help you to identify where you may have compliance practice gaps as well as how to fix them.

This webinar will discuss the basics of product registration in Japan such as Registration Timelines, documentation requirements and governmental processes.

This webinar training on stress testing in financial institutions will depict scenarios, pitfalls to be avoided, and discuss how the choice of the right scenarios can provide good insight into strategic management of a financial institution.

The Latin America Regulatory compliance requirement training/webinar will cover topics across the full Life-Cycle of Company & Product licensing in the key markets of Latin America [Brazil, Mexico, Argentina]. Written Regulations vs. Skillful Negotiation will be explained across every critical topic. The importance of local resources, Agency meetings and knowing how to navigate the regulatory landscape will accelerate country establishment and successful product licensing.

In this 60-minute session, the trainer will cover all the recently approved changes and details for returning an unauthorized transaction, including when to use a R10 or an R11 Return Reason Code. Examples used throughout the session will outline these changes, describe their effect on you as a participant in the ACH network, whether you are an RDFI or an ODFI.

ISO 14001 and ISO 50001 are related standards for environmental and energy management systems, whose implementation can deliver substantial bottom line financial results for their users. What relates them is the fact that material and energy that enter a process must come out either as a saleable product or waste, and elimination of waste flows directly to the bottom line and this webinar will provide simple analytical tools with which to achieve this.

This training program will answer questions related to IFRS financial statements and compare them to GAAP based statements using numbers from examples that come from every-day life. The course will also analyze the four key principles of IFRS and the cash flow statement, and discuss using financial statement notes to decode the numbers.

This training program will highlight mistakes often made when corrective and preventative actions are not clearly identified and applied during a manufactured product sterility test failure investigation because an ineffective investigational procedure and tool was used to conduct a sterility test failure investigation. The webinar will also illustrate how avoiding such common mistakes will ensure that these types of products meet the sterility requirements USP <71> and other regulatory guidelines applicable to finished products, bulk drug substance, raw materials or excipients.

This 6-hour virtual seminar will help you establish an efficient and effective CAPA (Corrective and Preventive Action) process leading to improved quality and compliance for your company. You’ll gain insights into the regulatory expectations, the myths, and the challenges of managing CAPAs so you can avoid common problems and pitfalls. You’ll learn how to streamline and monitor your process to ensure compliance and improved performance.

This webinar distills learnings from more than 20 years spend providing guidance to biopharmaceutical companies and related stakeholders. You will learn how to find and evaluate branded and generic entry opportunities, how to anticipate changes in demand for drugs, and how to add value to your partnerships.

This webinar will identify elements critical to both the compliance and effectiveness of an On-the-Job Training (OJT) program and provide practical strategies for implementing them efficiently and sustainably. Whether your training program is just getting started or is highly mature, the tools and ideas presented here will help you optimize its effectiveness while reducing compliance risk.

This webinar will instruct participants on how to best recognize and understand operational risks, emerging trends, and how to establish great risk management techniques over this risk area.

This technical writing training program will offer attendees an understanding of how the reporting process supports products in the medical device industry. This virtual session will highlight the mandates for documentation set forth by the regulators, such as the FDA, ISO, and other governing bodies. The program will train attendees on effectively reviewing and revising documents and assessing your audience, in effect producing effective written correspondence.

This course will focus on Risk Management in the Pharmaceutical and BioTech space. It will cover Risk Management Programs and also managing general regulatory risks in the drug development process.

Join Elaine Eisenbeisz as she shows you how to use data to estimate a standard curve, how to perform computations for absolute and relative quantification. She will also present a few decision-making criteria and statistical tests that can be used with qPCR data.

This webinar will help you understand in detail Computer System Validation (CSV) and how to apply the System Development Life Cycle (SDLC) Methodology when validating computer systems subject to FDA regulations, which is critical in order to be able to develop the appropriate validation strategy and achieve the thoroughness required to prove that a system does what it purports to do. It also ensures that a system is maintained in a validated state throughout its entire life cycle, from conception through retirement. We will discuss the phases within the SDLC, and how these form the basis for any CSV project that you may undertake, and the importance of the sequence of steps will also be covered, to ensure you are able to comply with FDA expectations.

This laboratory compliance training will teach you how to validate an analytical method under the GLP requirements. It will cover in detail the criteria for the validation of an analytical method including statistical and documentation requirements.

In this food safety webinar attendees will learn the broad overview of the Safe Food for Canadians Regulation (SFCR) standard to process, import or export foods for Canada covered with background, new revisions, enhanced regulations, tools and portal for compliance.

This webinar is prepared to explore how foods are regulated in Canada. We need to learn those laws in order to understand how to best manage compliance. The broad goal by the end of the webinar is to gain a better understanding of how foods are regulated in Canada.