Compliance Training Webinars for Regulated Industries

This webinar will cover the requirements for laboratory controls under US GMP regulations, such as those relating to equipment calibration and preventive maintenance; sample chain of custody; good documentation practices; investigation of out of specification and out of trend results; analytical method validation; change control; impact of staffing levels and work flow patterns in the lab on GMP compliance; training and other issues.

This session will help the attendee to identify a Third-Party Sender (TPS) and a “nested” TPS. In addition, we will cover the details needed in the agreements between all parties and what parties based on their role. Discussion on the registration requirement for both the TPS and the nested TPS and what that means to the ODFI.

The definition of labels is well defined and ususally well known; "labeling" not so well. Differing requirements for different applications can be confusing and are the subject of this webinar.

Data Integrity has been the subject of increasing scrutiny during pharmaceutical regulatory inspections in recent years. Chromatographic data systems have received particular attention because of the potential for data manipulation to produce fraudulent data or uncontrolled changes in processing parameters that compromise the comparability of results between runs. This webinar explains the intention behind data integrity regulations, sets out current expectations and suggests an approach to compliance based on sound science.

Attend this training to understand all the requirements of the Toxic Substance Control Act (TSCA), its revisions, and how to develop a written plan, TSCA Training Plan. Get answers to your TSCA questions.

This 90-minute webinar will provide valuable assistance to all regulated companies performing and documenting meaningful, results driven 510(k) / change analysis activities, based on the FDA's new Draft Guidance, "510(k) Device Modifications: Deciding When to Submit a 510(k) for a Change to an Existing Device", dated October 25, 2017.

This course provides guidance in how to implement and maintain the desired level of credit risk management with practical tools and techniques. Both the market and the regulatory agencies expect credit risk management to reflect the bank’s credit culture, so the class also offers direction on how to identify the organization’s credit culture and to reposition it to support the desired credit risk culture and management.

This webinar will prepare your staff for this filing year, improve your employee reporting set-up and maintenance practices, and reduce your risk of complaints from the IRS. Learn the latest updates on Form W-4 and Form W-2 wage and withholding reporting.

As a “GxP” system, following Good Manufacturing, Laboratory and Clinical Practices, the computer system must be validated in accordance with FDA requirements. If electronic records and/or electronic signatures (ER/ES) are incorporated into the system, FDA’s CFR Part 11 guidance on ER/ES must be followed to assure data integrity is maintained. This webinar will focus on the efforts by FDA to modernize their own technology infrastructure, and what this means to industry. We will cover the Technology Modernization Action Plan (TMAP) that has been launched by FDA for this purpose and discuss specific actions that are planned and in progress.

This training would provide tools that can be implemented and used after this event. This includes practical tools. We will discuss why supervision is so important in reducing and preventing human error. Supervision approaches near root causes and root causes for supervision related errors and will address the main five elements to assure an error-free environment.

This GLP quality system webinar provides a general overview of the Proposed Rule, a GLP QMS and its implementation, GAP analysis, Plan-Do-Check-Act cycle, process control and optimization theory and quality audits are utilized for the analysis of an existing QMS and the potential benefits, barriers steps to implementing an optimized GLP QMS.

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.

21st century business organizations require active and engaged risk management activities. Today's risk and compliance process is rather complex and dynamic, therefore it requires governance, risk and compliance professionals to possess certain skills in order to effectively complete their duties and responsibilities. The days of using staid audit programs are over. This training program will engage participants in evaluating each business process using a risk-based approach and in preparing risk and compliance documentation for each engagement.

Learn the best practices for eliminating 1099 error notices from the IRS. Discover the power of the TIN Matching system. Discover the smoothest way to register to use the two step verification process introduced 12/10/17. Learn how to handle the CP-2100 notices from Uncle Sam and avoid the fines & penalties for failure to timely comply with the B-Notice requirements. Understand the difference between and 1st and 2nd B-Notice and the related differences in required vendor responses. Be sure you institute and stop Backup Withholding when required. Join us for a content-rich 2-hours and you will gain the tools to make you the most effective information return manager your company has ever seen.

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.

Recent updates to the Nacha Operating Rules were developed to enhance the ACH “user” experience with improvements and simplification by adopting new technologies and channels for the authorization and initiation of ACH payments. Included in the change was a reduction to the barriers when using the ACH Network by providing clarity and increasing consistency pertaining to certain ACH authorization processes and by reducing some of the administrative burdens related to ACH authorizations. What does all this mean will be covered in this 90-minute webinar, explaining how this new Rule applies (and it is optional for Originator/ODFI).

This webinar will provide participants with a comprehensive understanding of the Americans with Disabilities Act and will explain the importance of compliance and the consequences of non-compliance. Participants will gain a solid understanding of the ADA’s disability accommodation process and the interactions between Federal and State laws.

In this training program attendees will learn the key elements needed to develop a proactive Regulatory Compliance Written Program. After this webinar, you will have confidence in facing the next EPA regulatory compliance audit that comes your way.

This training will evaluate the chief areas of an FDA cGMP compliance audit and help you understand the actual and anticipated changes in emphasis based on this new regulatory climate. It will prepare you and your company for tougher US FDA cGMP compliance audits.

This training program will enumerate the requirements of the Emergency Planning and Community Right-to-Know Act (EPCRA) as it applies to your organization. It will also help attendees understand the threshold trigger for reporting a hazardous chemical on the Tier II forms and learn how to accurately calculate chemical mixtures as it applies to the Tier II forms. Further, attendees will learn to navigate the complexities of online Tier II reporting.