FDA Audit and Inspections Regulatory Compliance Training - Live Webinars, Recordings & CDs

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 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 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 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 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.

This SOP best practices webinar will show how to create “state of the art” SOP or review your current SOP so as to successfully manage FDA Investigators and other Regulatory Authorities Audits which can help improve and influence Audit Outcomes.

The regulatory expectations for both pharmaceuticals and medical devices will be emphasized as well as overview of best practices for timely and effective investigations. This webinar will provide valuable assistance and guidance to the life sciences manufacturers engaged in various aspects of product complaint investigations.

This Design Control Inspection training will review of the sections of Quality system regulations, design control regulations which FDA uses as an inspection tool. Actual FDA investigator training methods related to design control inspections. Real life examples of FDA design control compliance issues will be examined.

This system based inspection for Laboratory Control System training/webinar includes measures and activities related to laboratory procedures, testing, analytical methods development and validation or verification, and the stability program.

This FDA Inspection training will provide you an understanding of how the FDA conducts systems based inspections, and will review examples of FDA 483 observations, so you can better prepare for your PAI.

This FDA inspection training will discuss how to prepare for the inspection, what to do during the inspection and the close-out interview, and how to respond to the inspection.

In this FDA audit & Inspection training we will focus on ideas that will help identify areas of improvement before the formal inspection occurs. Further, you will learn techniques that will enhance your effectiveness during the audit execution.

This FDA audit & inspection training will provide your firm with key insights on how to perform superior supplier audits. It will help you uncover purchasing controls GMP violations.

The FDA Audit inspection training defines the laboratory environment; points out problem areas and common pitfalls; and details solutions and also details how to prepare the Laboratory staff for an Inspection as well.

This FDA GMP (Good Manufacturing Practice) inspection training will walk you through the elements you should plan for, the timing and the logistics of who should do the various components in preparation for the inspection.

This FDA Inspection training will examines the audit process and how to manage Process Deviation Investigations.

In this presentation, we will look at these documents from the investigator’s point of view, reviewing the FDA training manual and actual FDA warning letters and responses. This will reveal what the investigator is trained to look for and what types of problems are actually being discovered in the field offices.

This FDA inspection training compiles the best practices now being used by many companies to host FDA inspections that will satisfy FDA inspectors and result in a good experience for the company. FDA inspections require a large amount of preparation and knowledge. Are you informed enough to avoid Warning Letters

This FDA audit training will provide invaluable assistance to investigators and their staff in the regulatory / legal responsibilities and also the ethical considerations in pharmaceutical product (Drug or device) research involving human subjects. Data keeping for clinical research trials involving human subjects has to be as accurate and valid as possible. Does yours meet the mark?

This guidance is intended to assist in applying current good manufacturing practice (CGMP) required under section 501(a) (2) (B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) in the manufacture of most investigational new drugs (IND).