Quality and Safety Regulatory Compliance Training - Live Webinars, Recordings & CDs

This training program will discuss fundamentals of infection and the use of materials/drugs to fight infection, FDA regulatory approvals for drugs and materials used to fight infection, and future thoughts on approaches to fight infection.

This 90-minute webinar will help you gain a comprehensive understanding of ICH GMPs and the nuances and differences between requirements in the US, EU and Japan. It will prepare you for regulatory inspections in these countries.

This training program will help attendees understand the sources of mycoplasma contamination and how to minimize the occurrence of contamination. The regulatory standards for testing will be described as well as the methods of mycoplasma detection and the resources for testing. At the conclusion of this webinar, attendees will have knowledge of the importance of mycoplasma contamination testing and how to successfully perform the tests in their company’s setting.

This training program will assist those responsible for planning, executing or managing the integration of a business system with any laboratory system governed by FDA regulations. On completing the program, attendees will have an understanding of laboratory system computer validation planning, execution and management concepts, and how they apply to any integrated business system.

This training program will help attendees understand what adverse events, serious adverse events and unanticipated problems are, and why reporting them is important to a study hypothesis and is key to keeping subjects safe while on a clinical trial. They will also learn the responsibilities of the sponsor, site/clinical investigator and regulatory agency in reporting adverse events.

The objective of this virtual training seminar is to assist attendees in understanding and being able to apply FDA regulations for OTC drugs and to label and market them successfully in the U.S. while avoiding regulatory problems. The program will also explore other verticals such as: OTC drug monographs and their importance to product marketing, a summary of OTC drug GMP regulations, FDA rules for adverse event reporting of OTC drugs, avoiding FDA Warning Letters, and more.

The webinar will discuss the current available regulatory pathways to develop FDA-regulated 3D printed products and also predictions on what to expect in the near future. 3D printing in personalized treatments will be discussed and attendees will be provided practical tips for pursuing approval with the FDA.

This training course will provide a detailed overview of the regulatory requirements, local challenges and important cultural aspects of working with the lifecycle of life science products (pharmaceuticals, medical devices, biologics and combination products) as an importer or producer in Russia. It will offer a deeper understanding of cultural norms, and will discuss best practices for establishing relationships and protecting your intellectual property to be integrated into your company’s training and corporate business strategies.

This training program will discuss MHRA GMP data integrity definitions and guidance. It will also highlight the difference between intentional and unintentional failures of data integrity and examine how regulatory agencies detect data integrity problems.

This webinar will cover the regulatory perspective in testing raw materials for microorganisms and how you can manage the risk of raw materials being the major source of microbial contamination in your medical product manufacturing process.

This training program will discuss key terms and responsibilities related to FDA inspections and the purpose of the BIMO inspection program. It will also review the general purpose and overall process of an FDA inspection and enhance your inspection preparation strategies.

This training program will provide a review of the current testing requirements and discuss what happened to the old 87/91 LAL Guidance for Industry proposed guidance. The program will also discuss how to transition from one bacterial endotoxin test to another—understanding the RPT (Rabbit Pyrogen Test). Participants will also gain a clearer perspective of the Monocyte Activation Test (MAT).

This training program will provide attendees with the ultimate set of tools in order to help their firms properly create User Requirement Specifications (URS) for Computer Systems Validation (CSV) with emphasis on current industry trends in this particular area as well as current Food and Drug Administration (FDA) regulatory trends and enforcement activity.

In this training program, attendees will learn how process robustness tools and metrics can be utilized to enhance process understanding and control. The new FDA paradigm is shifting to the expectation that organizations certified by other standards such as ISO and EFfCI demonstrate process robustness. It is the obligation of the primary pharmaceutical provider to ensure process robustness throughout the supply chain.

Among other key topics, this training program will focus on what can be monitored in mixing operations, wet granulation operations, dry granulation operations, compaction operations, and coating operations.

This training program will guide attendees on how to best deliver water from a high purity water distribution system. Attendees will learn to capitalize on the advantages of online analytical instrumentation and understand the value of rapid microbiological methods. The program will also offer an understanding of real-time release of water.

Attendees will come away from this training program with a good understanding of upcoming changes to the ISO standard and the implication of those changes to the classification and operation of clean rooms in regulated industries.

This training program will enumerate the inspection process for API, drug and device manufacturers and summarize recent changes. It will guide attendees on preparing staff for the new FDA inspections and discuss the role of exit meeting to avoid enforcement.

This webinar will review FDA’s regulations related to suppliers in manufacture of drugs, biologics and medical devices. It will discuss the current regulations, guidance documents and best practices for supplier management and enforceable quality agreement using case studies for a variety of scenarios. Common FDA audit findings will be discussed.

This training program will dispel mistaken paradigms regarding the risk based approach to water system lifecycle. It will detail how to eliminate variability – the cause of most deviations. Attendees will learn how to capitalize on the advantages of online analytical instrumentation (chemical and microbiological rapid methods).