Pharmaceutical Regulatory Compliance Training - Live Webinars, Recordings & CDs

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.

This webinar provides a basic understanding and fundamental principles of Current Good Manufacturing Practices and will fulfill the requirement of personnel involved in cGMP must have documented training of current Good Manufacturing Practices. This session will focus on the FDC Act and 21 CFR federal regulations as applied to cGMP.

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 course offers practical approaches and tools to address human performance issues in GMP related environments by using a particular methodology to correct, prevent and avoid reoccurrence of these matters.

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performing and documenting meaningful, results driven 510(k) / change analysis activities, based on the FDA's new Draft Guidance, "510(k) Device Modifications: Deciding When to Submit a 510(k) for a Change to an Existing Device", dated October 25, 2017.

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.

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.

This project management training for FDA regulated companies will show how you can meet key FDA and EU MDD regulatory requirements for the project you manage. It will focus on proven tools and techniques for successful development and implementation of project management planning.

FDA regulates advertising and promotion material as labeling. The legal definition of labeling covers just about anything that explicitly or implicitly conveys a message intended to affect a person’s behavior and decision outcomes. How FDA applies its legal tenants of false and misleading information or variations on that theme requires continual updating by FDA and constant re-evaluation by industry. Now the regulatory landscape involves other federal agencies and academic principles in psychology. It has become very complicated and will prove very costly if you knowingly or unknowing walk into one of FDA’s legal snares. This webinar will bring attendees up to speed so you are clearer about what is a problem, what is not a problem and what becomes a risk laden judgment call.

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 instructor-led live webinar will discuss the established approach of Pharmaceutical Quality Management as it relates to the relationship between risk management and the pharmaceutical regulations that govern the business.

This webinar will teach you how to conduct an effective management review of the quality system which helps you understand how to plan and focus on right metrics and governed by an efficient process. Participants will also understand FDA policy regarding disclosure of management review information during inspections.