FDA Regulatory Compliance Training - Live Webinars, Recordings & CDs

This training program will provide professionals with essential elements of CAPA investigations to assure compliance with regulatory requirements. The corrective and preventive action (CAPA) program is an essential element of a compliant quality management system, as required by international regulations and voluntary standards. Investigations are the backbone of the CAPA program.

The training program will prepare attendees to better understand the revisions to this standard as they read its requirements in detail. For those organizations that have a QMS that's compliant with ISO 13485:2003, you will benefit from this program as it will help you assess your preparations.

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.

This training program will discuss stem cell sources and how to control stem cell differentiation, technologies (FDA and non-FDA) that exist in stem cell technologies, and the future directions and opportunities that exist for stem cell technologies.

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 training program will discuss how to effectively create performance metrics and goals for your department or project. It will also discuss the key components of a metric and when to use different types of performance metrics.

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 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.

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.

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 provide attendees with an introduction to FDA’s veterinary drug approval process. It will also discuss key components of an appropriate animal field study needed to support new animal drug approval and explain how jurisdiction is split between various federal agencies in certain cases.

As one among the most leading causes for warning letters and consent decrees, software validation and its compliance are essential to keep your business ready for FDA audits and inspections. Learn best practices to conform to FDA software validation requirements in this webinar with a leading FDA and regulatory affairs expert.