Compliance Training Webinars for Regulated Industries

This webinar will discuss in detail the requirements of 21 CFR part 11 and updated European Annex 11 regulation including requirements for local, SaaS, and cloud hosting. It will also offer techniques to implement a computer system using risk-based validation to gain maximum productivity and reduce cost by as much as two thirds.

This IT Audit webinar facilitates an executive-level understanding of the ISACA IT Auditing Standards associated with performing IT assurance services and accepted areas of risk for most organizations through exposure to The Davis Adaptive IT Auditing System and Governance Tree frameworks. Webinar presents guidance following the general structure of planning, studying, testing, reporting, and follow-up. This structure can be applied broadly, or narrowly, defined IT audits.

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 2-hr webinar on Service Level Agreements (SLAs) will provide you with sound principles and a set of guidelines for developing and preparing ‘effective’ Service Level Agreements (SLAs) for an internal service function or an outside service provider.

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.

In this webinar attendees will learn about FDA’s regulatory expectations for classifying, assessing the risk, testing, and validating a computer system used in FDA-regulated work. Also attendees will learn in detail about the System Development Life Cycle (SDLC) methodology used to approach Computer System Validation (CSV), including all of the phases, sequencing of events, deliverables, and documentation requirements.

This webinar will discuss FDA requirements related to cloud computing. It will provide step-by-step recommendations for using 'clouds' from planning to reporting.

This training program will equip attendees with basic everyday tools to keep cyber criminals at bay. The course will also emphasize the need for effective communication between team members of a financial firm.

This webinar will teach you how to design, build and test medical device software in preparation for the successful 510k submissions. It will cover medical device software user requirements, software architecture, design, unit testing and more.

Learn corporate policy definition and assignment with ramifications for both. We'll discuss how to identify and document management review controls, why a fine tuned policy and procedure are critical to business operations and how to obtain the real root cause of cyber security incidents effectively.

This webinar will focus on legal requirements related to personally identifiable information (PII) security as well as HR’s critical role in data security. It will also provide practical tips on PII security, vendor management, and planning your data breach response.

This webinar discusses the genesis of RFIs and their development and the use and abuse of RFIs on construction projects including ways to mitigate the potential adverse impact of RFIs. Speaker discusses a number of contractual mechanisms to control the RFI process and mitigate potential impact damage claims based on the number of RFIs. The webinar also sets forth best management practices concerning the RFI process.

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 analyze how proactive monitoring of workforce access to e-PHI can reduce false positives and support the HIPAA Security Rule administrative safeguards. It will also discuss how software platforms can help covered entities increase confidence in adherence to minimally necessary standard.

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.

This webinar discuss how big data is used for AML compliance review. The instructor will explain how an unstructured data, becomes structured and is subjected to data quality review, sampling and subsequent forensic analysis. The instructor will share how this analysis influences strategic decision in terms of risk mitigation and AML Program enhancement.

This training program will prepare your organization to understand the need for data security, the steps that can be taken to institute or augment your data security policies/procedures, and the implementation of the needed controls. This webinar will introduce attendees to a set of known and respected data security standards that can be employed by your organization to improve your security. Attendees will walk away with ideas to leverage the curriculum with their existing security infrastructure.

Upon completion of this training program, attendees will have an understanding of laboratory system computer validation planning, execution and management concepts, based on the System Development Life Cycle (SDLC) framework. They will have received the guidance on industry best practices necessary to develop a compliant and cost-effective validation program. They will understand the steps for validating laboratory systems, along with the key documentation associated with maintaining the systems in a validated state, while minimizing costs. Attendees will gain a good grasp of how to leverage these practices across all systems by creating a standardized program.

This training program will assist those responsible for planning, executing or managing the integration of a business system with any laboratory system governed by FDA regulations. On completing the program, attendees will have an understanding of laboratory system computer validation planning, execution and management concepts, and how they apply to any integrated business system.

This training program will provide attendees with the ultimate set of tools in order to help their firms properly create User Requirement Specifications (URS) for Computer Systems Validation (CSV) with emphasis on current industry trends in this particular area as well as current Food and Drug Administration (FDA) regulatory trends and enforcement activity.