Life Sciences Regulatory Compliance Training - Live Webinars, Recordings & CDs

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 explore why planning and implementing an information management solution can be a daunting task. Composing policies and procedures is a good start, followed by testing in small groups. But a lot of people are resistant to changing their work practices, especially if they have been working for an organization for a long time. The worst thing that can happen is that staff appears to be compliant with the new plan, but has found a way to continue their prior practices under the radar. The solution to this problem is a comprehensive initial and continuing educational plan.

This training program on Auditing the Microbiology Laboratory will focus on sampling, sample control, and chain-of-custody. It will detail contract services - qualifying them and reviewing/monitoring their performance and results; and method validation, tech transfer, and inter-laboratory comparison testing of unknowns.

This webinar will explain how to apply the theory of lean documents and its corollary theory of lean configuration to present a fresh approach to these linked and cascading documents.

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 training program will provide tools require to understand what a good Request for Proposal (RFP) looks like, how to write one, and how the job of selecting a vendor becomes easy when these tools are employed.

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 on 21 CFR Part 11 guidance for clinical trials will explain the new 21 CFR Part 11 regulations for electronic records and what that means for your organization and the clincial studies you conduct.

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.

This training program will critically assess the number of major and critical 2012 inspection findings related to trial oversight. Attendees will learn to identify regulatory requirements for appropriate delegation of duties and investigator oversight.

This training program will illustrate the underlying idea that makes ANOVA work. It will also offer an understanding of the data collection issues you should plan and how to get access to ANOVA in Excel.

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 90-minute webinar will review FDA's draft regulations for UDI and describe the new requirements for labeling medical devices. It covers the new regulations in 21 CFR Part 830, the changes to Part 820, the Quality System Regulation; Part 801, Labeling; Part 803, Medical Device Reporting; Part 806 Corrections and Removals; and other regulations.

Attendees will come away from the training program with the tools they need to understand the various types of enclosures and how to select the correct type of enclosure for their process in order to meet regulations, protect the product, and ensure worker safety. The course is apt for personnel in FDA regulated industries who want to learn about what enclosure is best suited for their process and why.

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.

This FDA training program will guide attendees on how to get the best advice from FDA with the proper actions before, during and after your FDA meeting.