Compliance Training Webinars for Regulated Industries

The rapid expansion and broad applicability of software functions / applications deployed on mobile or other general-purpose computing platforms has created concerns with industry and the US FDA. This has resulted in the FDA focusing on the subset of software functions dealing with medical issues which the Agency intends to apply its authority. What are these issues / software app claims, and how will this affect the medical device industry.

This training program will offer attendees an understanding of human errors in GMP related environments, factors and causes, and control measures to be put in place to reduce the same.

This session will include the requirements for all of the complaint handling responsibilities, which will include defining, documenting, and implementing a complaint-handling system, the requirements for complaint review, investigation, and corrective action, as well as ISO-specific implications. Also covered will be a discussion of what constitutes a complaint, and recommended practice on how to handle "non-complaint" feedback. Also covered will be the application of risk management to a complaint handling system, and a specific risk management system explained.

Despite growing available information and training materials about the critical value of Software Asset Management, many organizations still find themselves unprepared for a software license compliance audit. A software license audit can cause severe disruption and takes time and resource away from business as usual. In this webinar, Dr. Davis will discuss the different approaches to achieving software license contracting compliance.

This webinar training pays for itself in terms of your firm's potential savings and detection of fraud. The training is designed to both prevent and detect fraud. We first teach you how to establish an administrative environment where fraud is less likely to occur. We’ll then examine Excel tools that are used by CPAs and Internal Auditors to detect fraud.

This webinar will be an informative session for all financial and non-financial professionals to understand the financial statements like balance sheet, income statement, cash flow and more. Participants will learn how to analyze and interpret these statements to assess the profitability, liquidity, efficiency and leverage of their company.

This course provides medical device/pharmaceutical professionals with the information they need to prepare for and manage any type of FDA inspection. This course provides the rationale, strategies and flow on how to plan for an inspection, the inspection process and approach, and which company roles should be assigned for these types of inspections, among other related topics.

Government laws and regulations usually require an entity’s management to design, implement, and maintain a control system. However, controls existence and effectiveness verification are commonly an external and internal statutory audit responsibility. Auditors that conduct entity compliance attestation engagements focus on examining, reviewing, or performing agreed-upon procedures regarding a subject matter or assertion about a subject matter and reporting evidentially supported results.

All public water systems (PWSs), except aircraft PWSs subject to the Aircraft Drinking Water Rule (ADWR) (40 CFR 141 Subpart X), must comply with the RTCR as of April 1, 2016. Are you in compliance 5 years later? In this webinar, learn what do you need to do to be in compliance?

The ability to present articulately to management, to the customer, or a non-tech audience can significantly enhance your credibility. Delivering engaging presentations at work or professional events is a way to share your ideas and gain a reputation as a valued employee and an expert in your field.

Cannabis, or marijuana, is illegal under federal law. However, at least 30 states and the District of Columbia have legalized marijuana for medicinal use and nine states, soon to be more, have legalized it for recreational use. This conflict presents a unique challenge to employers. At the same time, the illegal use of legal prescription drugs has reached, in the words of the Center for Disease Control, epidemic status. What do employers need to know about this new drug environment at work? What policies and procedures need to be addressed? How do employers comply with the new regulations? What about my pre-employment drug testing program? These questions and others will be answered by this webinar.

A key component of building a clinical research finance team is creating a staffing model that will support the health system’s clinical research portfolio. This course focuses on key metrics and KPIs to help attendees develop a staffing model for their organization.

This webinar explores the issue of what should the process be between employer and employee when trying to accommodate individuals with disabilities while complying with the Americans with Disabilities Act.

Validation is an important element of the Quality System Regulations and ISO 13485. This course will cover the validation essentials for medical device manufacturers. You’ll learn about what processes needed to be validated and what steps you need to take to validate processes. Validation is a powerful tool in understanding, optimizing, and controlling manufacturing processes. We’ll cover the essential steps of Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) including tips and best practices.

In this webinar, you will how to manage General Safety and Performance Requirements (GSPRs) according to EU MDR 2017/745 Annex I for full compliance with new EU Medical Device Regulation mandatory starting 26-May-2021

Tired of applying the same types of discipline and still getting the same old mediocre or short-lived results? Or maybe it was a “righteous” discipline, but it still was overturned or mitigated by a hearing officer or arbitrator. If so, you might be ready to broaden your horizons and considering how treating employees like adults can not only avoid these issues but empower employees to act like adults which can also result in positive changes to not only their conduct and performance but to your bottom line as well.

Lookup formulas are far superior to manually searching for specific data elements in a spreadsheet. VLOOKUP, HLOOKUP, INDEX and MATCH are some of the most well-known (and most useful) functions in Excel which are used to to return data from other locations in worksheets. VLOOKUP enables you to quickly and easily look for a value in a column of data and return a value from the same row in a different column. This is invaluable when working with large tabular data. INDEX and MATCH work in a similar way but provide more flexibility. If you handle large amounts of data in Excel, this webinar will help you tremendously.