Compliance Training Webinars for Regulated Industries

The objective of this interactive, live training webinar is to explore the management of OOS practices and suggested avenues to take to minimize deviations, OOT, OOS and CAPA and how to attack these situations should they occur. It is also designed to determine how FDA and ICH regulations and guidances may impact them. It will also reference the new PDA TR 88, “Microbial Data Deviation Investigations in the Pharmaceutical Industry”.

The Webinar will focus on the importance of ensuring that electronic record/electronic signature (ER/ES) capability built into FDA-regulated computer systems meets compliance with 21 CFR Part 11. This includes development of a company philosophy and approach, and incorporating it into the overall computer system validation program and plans for individual systems that have this capability.

According to the Nacha Operating Rules, financial institutions are required to assess and manage all ACH risks, which includes developing a Risk Management program. Most ACH risk can be mitigated through proper due diligence for all originating customers (KYC) and strict adherence to ACH origination and credit policies, which includes monitoring ACH activity.

Gamma and EO Sterilization verification and validations under the U.S. FDA and EU's EMA / MDR requirements

Are you as knowledgeable in the Fair Lending regulations? Do you know how they pertain to your role and responsibilities? Has your compliance program changed with the changes in regulations? During this webinar we will go through each of the regulations that fall under Fair Lending and take look at the latest developments in regulatory compliance.

The webinar will provide useful methods and techniques for conducting a stability study and analyzing the resulting data for the purpose of estimating shelf life. Participants should be able to immediately apply the methods presented. Also, the interpretation and communication of results will be stressed and illustrated in several examples.

This webinar will help you understand GMP requirements for change control from a pharmaceutical manufacturing perspective, the purpose of change control and what types of changes are or are not subject to change control. Participants will learn how to execute and implement a change in a regulated environment.

This targeted 60-minute U.S. Reimbursement training/webinar will help you understand and navigate the complex U.S. system for understanding product reimbursement status and potential for your Medical Device

The U.S. FDA and EU's MDR require specific steps to be fulfilled to develop and/or transfer analytical methods to maintain accuracy.

In this cleaning validation webinar attendees will learn the Total Organic Carbon (TOC) feasibility, method validation and transfer from the laboratory to the manufacturing floor, as well as reviewing a feasibility study of multiple, difficult to oxidise or low solubility organic compounds.

This webinar will focus on the current trends in FDA Inspections and guidelines and how this information can be utilized to provide a foundation for compliance with the latest quality and regulatory requirements. Attendees will learn how to proactively prepare for an inspection.

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 training will review the best practices establishing and conducting a cleaning validation for reusable medical devices. It will also address the requirements of ANSI/AAMI ST 98.

Learn how to use Learning Management Systems (LMS) to create effective pharma training curricula and ensure GMP compliance. This webinar delves into the unique challenges of creating intuitive job position curricula, overcoming LMS limitations, and meeting FDA requirements. Discover how to define true pharma curricula, collect job function details, manage complex training needs, and demonstrate compliance during audits. Ideal for professionals looking to optimize training in pharmaceutical environments.

It is important that the sterile filtration process is fully understood and properly validated for your particular application. The process requirements and validation needs differ based on the filtration requirement. This webinar will offer attendees a comprehensive understanding of the same while emphasizing the different types of sterilizing filtration available and their application to your particular system. For instance, the application of sterile filtration to use-point compressed air will be discussed in detail.

This technical writing training program will offer attendees an understanding of how the reporting process supports products in research, development, and in the marketplace. This virtual session will highlight the mandates for documentation set forth by the regulators, such as the FDA, the ISO, and other governing bodies. The program will train attendees on effectively reviewing and revising documents and assessing your audience, in effect producing effective written correspondence.

This FDA compliance training will cover in detail the new requirements for trial master files including documents related to clinical trials that are required to be prepared, collected and maintained as part of the TMF.

Both the U.S. FDA and EU's MDR expect documented risk-based IQ, OQ, an PQs of medical packaging lines under U.S. FDA cGMP, EU MRD, ICH Q7 and Q9 and ISO 14971

Attend this webinar to learn about the different contract terms, different ways to determine the scope of the audit given contract terms and conditions, how to plan, perform and report results of a vendor audit.

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.