Compliance Training Webinars for Regulated Industries

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.

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.

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.

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.

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.

This training program will detail how to create a bullet-proof AP operation that is setup to detect and proactively prevent fraud from occurring. During this session, the webinar presenter will discuss real cases of AP fraud and the controls that organizations later realized needed to be added to their AP operation, unfortunately too late to prevent these costly incidents. In addition to discussing good controls, he will also discuss common controls that are ineffective, provide no value, or even leave AP departments with a false sense of security while they are in reality still very much exposed.

This webinar on Process Validation Requirements will go over the foundations of process validation, with an emphasis on going beyond compliance to achieve a robust process. Review of the fundamentals of process validation, with an emphasis on looking beyond compliance to achieve a robust process.

This webinar will explain the Civil Monetary Penalties Law (CMP) and its mandatory and permissive exclusions and penalties. It will also cover obligations under EMTALA, violations of the Anti-Kickback Statute and Stark including amendments under the PPACA.

This seminar will provide an insight into the practical aspects of the Process Analytical Technology (PAT) batch and continuous manufacturing of pharmaceutical products. You will learn about regulatory initiatives to improve the quality of solid dosage pharmaceutical manufacturing using PAT. No special technical background is required.

In this webinar, learn the best practices for avoiding common unfair labor practices (ULPS). It covers the many issues/challenges involved with impasse; bundling/packaging; internal and external influences; mediation; ratification; communicating during the final stages and post-agreement strategies; publication of the agreement and post negotiation training.

This webinar will include a detailed discussion of Contract Manufacturing Organizations (CMO) Quality Agreement topics such as change control, documentation, facilities and equipment, lab controls, sub-contracting, etc. Attendees will learn how to comply with new FDA and EU guidelines for contract drug manufacturers.

In today’s world, every organization no matter how large or small needs an Incident Response Plan in place to quickly manage and address the consequences of a breach. The volatility of today’s threat landscape makes an incident response (IR) more challenging than ever. This webinar is designed to give information security professionals an overview of the various considerations and aides in IR planning.

Did you know that every employer, regardless of industry, has the potential of an employee working alone? Regardless if the employee is working alone for an entire shift, partial or a very small percentage, providing safety for that employee is essential for meeting regulatory compliance.

In the state of California, employers often struggle with abuse and fraud of protected leaves of absence as those granted by the Family & Medical Leave Act (FMLA), the California Family Rights Act (CFRA), and the Pregnancy Disability Leave Act (PDL). Employers feel uncertain how they can avoid complex leave of absence issues while protecting their own financial and business needs. The overlap between these pieces of legislation is often confusing and seemingly complicated. All three pieces of legislation provide ways in which an employer can identify an employee’s need for leave while vigilantly remaining alert to potential leave abuse.

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 webinar will teach how to calculate the Z-score and “correctly” interpret it based on a straight-forward scale. Five-step “key ratio analysis ” plan (liquidity, activity, leverage, operating performance, and cash flow analysis) will be displayed and tied into the comprehensive calculation of the Z-score. The session will conclude with a review of using sophisticated software such as Moody’s Lending Cloud to calculate both the Z-score and key ratios.

In this webinar, you will get an overview of FDA’s medical device Quality System Regulation, 21 CFR Part 820.

This webinar will discuss the current status and outlook for federal oversight of Laboratory Developed Tests (LDTs) amid bureaucratic infighting during the COVID-19 pandemic regarding the authority of the Food & Drug Administration (FDA) to regulate LDTs.