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Computer System Validation (CSV) vs. Computer System Assurance (CSA): Aligning the Agile Methodology to the GAMP 5 “V” Model and System Development Life Cycle (SDLC) Methodology

Advancements in technology have forced organizations to rethink business models. Once controlled and orderly, these organizations are now more chaotic and complex, serving patients and customers that are better informed and with higher expectations than ever before. Work practices and tools must change to meet these challenges.

The approach to developing software, performing validation and maintaining a system in a validated state through its entire life cycle should be carefully considered in order to meet changing needs. This webinar will include a comparison of the Agile and Waterfall methodologies, along with the pros and cons of each. There may not be one size that fits all, and so it is important to understand what needs to be considered when making such a determination.

Essentials of IT Auditing for the Non-IT Auditor

Information Technology (IT) is a critical enabler of business. As computing power has advanced, enterprises have become increasingly dependent on technology to carry out their operational requirements and to collect, process, maintain and report essential data. This reliance on electronically encoded data and on the systems that affect managerial decisions are a major concern of audit professionals. Assuring an enterprise’s governance, including risk management and control processes, requires auditors to understand the role of IT within their organizations and to develop adequate knowledge and skills to audit IT systems as the line separating “IT,” and “non-IT” audits are beginning to disappear, except in the very technical IT domains.

Consequently, auditors examine the adequacy of controls in information systems and related operations to assure effectiveness and efficiency in business processes. In addition, among other assurance services, auditors evaluate the reliability of computer-generated data supporting financial statements and analyze specific programs and their processing results. To ensure maximum value delivery from audit area assessments, oversight committee members need an evaluation methodology that enables confidence in the work performed by auditors.

This course is designed to give non-IT auditors and beginning Information security professionals an overview of the various considerations and aides in audit planning to gain a greater understanding of how to evaluate defined audit areas.

Pre & Post COVID -19 Workplace Privacy Issues

Most employees will insist they have privacy rights, especially at the workplace. But few can state what those rights are. Likewise, not every employer or manager know what their obligations are when it comes to respecting an employee’s privacy rights or what the penalties are for not doing so.  And that was in a pre-Covid-19 world! But currently and in the foreseeable future the workplace will be raising issues about an employee’s rights to refuse to wear PPE, be tested, vaccinated or contact traced both at work or in their personal life since COVID-19 and the very nature of any pandemic is the highly communicable nature of the virus. This webinar has been developed to explore the foundations, current state, and possible future changes of privacy in the workplace.

Updates to the NACHA Rules Changes for 2021 and 2022

Each participant in the ACH Network is required to follow the Nacha Operating Rules and be compliant. There are several NEW amendments recently passed which will change the ACH Network processes – this is a NEED to know! In addition, an overview on Operations Bulletins (issued by Nacha) will be discussed (there are six of them for 2020). PLUS Operations Bulletin #7 that summarizes up COVID-19 Relief and Upcoming Rules Change Dates due to the uncertain times we are in at this time.

This session will provide the for changes to the Same Day ACH (SDA) environment (effective March 2021), the Unauthorized Return process with a new Return Reason Code R11 and the ACH Contact Registry (both effective right now in 2020) – NEW!!! and more!

Details on the new proposed amendment to the Nacha Operating Rules regarding Account Information Improvements Through the ACH Network, with a proposed effective date of March 18, 2022.
PLUS, Limitation on Warranty Claims, the Reversal Process and Rules Enforcement changes surrounding reversals, and Meaningful Modernization to enhance the ACH Network to keep up with changes in the payments landscape (all effective in 2021).

What You Should Know About Export Requirements for FDA Regulated Products from the US to Foreign Countries

This training will provide an in-depth explanation of FDA-Regulated Products that were exported from the United States to Foreign Countries. Also, it will address what export documentation must be used in the transportation of FDA-regulated products. Then, it also will discuss the FDA procedures that exporter must comply to meet the Modernization Act agreement. Lastly, it explains what local government and private resources that will have an impact on the exporter’s transaction process when it comes tariff costs in an FDA trading environment.