Compliance Training Webinars for Regulated Industries

This webinar will discuss the techniques for controlling and managing High Risk Transaction. The Instructor will discuss the parameters for identifying and qualifying transactions as high risk and process and communication to be followed. He will also discuss how to resolve the end result.

This webinar provides the logic and processes for determining samples sizes for common tests used in verification or validation of processes. The focus of this webinar is on providing the information needed for attendees to know the appropriate measures and formulas to use for the determining sample size and providing justification for the planned sample sizes.

This personal and business tax returns analysis training program will focus on key areas such as 1040 federal tax returns, K-1 forms, and tax code updates and how they affect bank’s clients. It will also discuss the structure of a C corporation, S corporation, and Partnership (including LLC) tax return.

This webinar will explain what money laundering is, various types of money laundering including structuring, micro-structuring and cuckoo smurfing. Attendees will learn how to identify the red flags of money laundering in an account within your institution.

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.

In this webinar, learn how to implement the changes required by the new regulation EU MDR 745/2017 in your current quality management system in a simple and quick way. The information in this course is vital to your passing the Quality Management Audit by your certification company or notified body.

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.

Clinical research revenue cycle (CRRC) is an integral part of a clinical research portfolio. It is a complex environment that bridges a health systems revenue cycle with clinical research activities. Health systems involved in clinical research activities struggle with effectively incorporating these two environments. In this course, attendees will learn framework for an effective and compliant CRRC program.

In this webinar, we will discuss the definition, purpose, importance of GDP, General rules of GDP, GDP as it applies to laboratory notebook documentation, US Pharmacopeia General Chapter <1029>, and introduction “Good Documentation Guidelines”. We will also briefly introduce you to the European Union (EU) GDP, and its enforcement along with some observation samples from FDA.

In this pharmaceutical water system webinar attendees will learn how to design, validate and maintain the new and existing water systems used in drug product manufacturing process. Different types of routine tests, testing frequencies, actions in each tests and sampling procedures associated with pharmaceutical water systems will be discussed to avoid any water systems failures.

The single most critical document in an FDA inspection is the master manufacturing record and associated batch production record. While the 21 CFR Part 111 regulations have a checklist of elements the documents must contain, it can be difficult to translate that into a working document. This training will review the basic principles of what an MMR & BPR must contain and give you tools to create an “FDA Acceptable” document.

This 21 CFR Part 11 compliance training will guide you through the requirements of Part 11 and will also explain its 3 primary areas: SOPs, product features and validation (10 step risk based approach).

Attend this course to gain practical approaches for supervision on the floor, strategies to get your group in sync and approach issues in GMP related environments by using a specific methodology to correct, prevent and avoid re-occurrence of these issues.

FDA’s recent focus on data integrity during computer system validation inspections and audits has brought this issue to the forefront of importance for compliance of systems used in regulated industries. These include all systems that “touch” product, meaning they are used to create, collect, analyze, manage, transfer and report data regulated by FDA. All structured data, including databases, and unstructured data, including documents, spreadsheets, presentations, images, audio and video files, amongst others, must be managed and maintained with integrity throughout their entire life cycle. It is a risk-based approach that leads to the best results and compliance with FDA’s expectations.

Attendees of this webinar will learn specific concepts and formulas commonly used to measure the ability of a process to produce output within customers’ specification limits. The focus of this webinar is on providing the information needed for attendees to know the appropriate measures and formulas to use for the various types of process data (attribute or variable).

Are you ready for the FDA to knock on your door? Although an effective Quality System should always be inspection-ready, many medical device companies make basic mistakes during inspections leading to 483s and even warning letters. This webinar can help you manage inspections efficiently and effectively. A professional, polished, responsive approach sets a good tone for an inspection. You will learn how to present information about your quality system in the most competent and professional manner.

An ethics and compliance risk assessment is the foundation of an effective ethics and compliance risk management program. This detailed course provides a 12-stage framework that will help you complete your own ethics and compliance risk assessment. The 12 stages are divided into two components, the Planning Phase and the Implementation Phase. With a completed ethics and compliance risk assessment and armed with your findings and action plan, you will be equipped to develop and implement an effective ethics and compliance risk management program.

In this webinar attendees will learn current law and regulations regarding the preparation of Forms W-4 and the filing of Forms W-2 and will provide practical guidance in these areas that have become the subject of increasing IRS scrutiny. It will cover topics related to how to report cost of employer sponsored health coverage, How to handle expense reimbursements made to employees, process to efficiently execute an electronic W-4 program, requirements of Electronic filing with the SSA using Business Services Online (BSO).

This training covers DEA record-keeping and security topics that a DEA registrant must comply with when handling controlled substances. The focus is elements of what occurs during that unannounced inspection and the auditing methods.

The NACHA Operating Rules are always changing, updates have recently been made and continue to be in place due to the current COVID-19 situation! Four ACH Operations Bulletins posted by Nacha in 2020 explain the updates to the Rules due to changes at financial institutions and extensions of effective dates in light of the current situation; and confirming some Rules changes with current effective dates remaining.