Pharmaceutical Regulatory Compliance Training - Live Webinars, Recordings & CDs

The objective of this live, interactive webinar is to explore raw materials in a cGMP environment, their various regulatory requirements and how they may affect the timeline of meeting the release date of your Company’s products. Please plan to bring additional personnel to the webinar to obtain cross-Departmental training.

This training program will address the common human errors and deviations related to the use of procedures. It will also offer best practices for writing SOP’s to reduce the likelihood of human errors.

Learn how to effectively develop, prepare, and execute job aids in the pharmaceutical industry. This webinar covers the key characteristics of job aids, their purpose, use in training, and their role in qualifying individuals for independent tasks. Understand the importance of document hierarchies, skill checks, and how to train others to deliver job aid training.

In today’s evolving GMP landscape, staying ahead of human error trends is critical. This webinar addresses cutting-edge strategies for managing human error as a systemic challenge—not just a behavioral issue. Gain insight into how the latest tools, including AI and predictive analytics, are reshaping compliance, training, and error prevention across regulated industries.

Regulatory decisions are never based on certainty—they are based on probability, risk tolerance, and the weight of evidence. This webinar explains how statistical concepts such as confidence intervals, Type I and Type II error, and uncertainty directly influence approval, compliance, and quality decisions. Designed for QA and Regulatory Affairs professionals, this session translates statistical outputs into practical regulatory judgment.

Artificial Intelligence is transforming how work is performed across FDA-regulated industries. Quality teams are experimenting with AI to draft procedures, summarize deviations, analyze complaint data, prepare training materials, and support inspection readiness. Regulatory groups are using AI to interpret guidance documents, generate submission content, and accelerate document preparation. Validation teams are exploring AI to assist with risk assessments and documentation. The productivity gains are real, and the pressure to adopt these tools is increasing rapidly.

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.

This live, interactive training webinar will examine a variety of the issues surrounding raw materials to include what materials should be tested and to what extent during Phase 1, 2 and 3. It will cover testing requirements as part of “Laboratory Controls” during each Phase and what laboratory testing may be optional until the ingredient moves to its next Phase. It will determine what options exist — even within a Phase 2 or Phase 3 testing framework. It will discuss compendial vs. non-compendial testing and how to respond when no method is available. Within the past several years the FDA has also issued a significant number of Warning Letters pertaining to 21 CFR 211.84 which involve management of raw/in-coming materials and which correspond to various sections within ICH Q7A. Please plan to attend the upcoming 90-minute Compliance OnLine webinar to learn how to avoid receiving this common citation and maintaining compliance with ICH Q7A. Please plan to bring an interdisciplinary group to obtain the most from this webinar.

This training program will offer attendees an understanding of human error, its factors and causes. The program will also identify the regulatory and business importance of human error prevention and define the process to manage human error deviations.

Packaging and labeling is often underestimated in the planning phases of pharmaceutical product development. This leads to unnecessary increases in cycle time, costly errors, and delays in product availability, or product recalls due to noncompliance. This webinar will help you succeed in pharmaceutical product launch by exploring its importance right from the conception of a product, its realization and distribution.

This webinar will focus on the Process for Quality Agreements and requirements that must be implemented to ensure compliance with the latest quality and regulatory requirements. Attendees will learn the reason for implementing a Quality Agreement system to assure adequate controls for Service Providers.

Mapping and evaluating all the steps in a pharmaceutical warehousing and distribution workflow can lead to valuable process improvements. In this webinar, we discuss how this review can be accomplished and the possible benefits that can result.

This webinar will teach attendees best practices for conducting effective quality audits to ensure regulatory compliance. Learn how to avoid potential pitfalls during the audit process.

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.

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

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.

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.

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.