FDA GxP and Best Practices Regulatory Compliance Training - Live Webinars, Recordings & CDs

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 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.

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 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 Validation training will explain the intent and importance of process validation, the connectivity between design control and process validation and the key pre-requisites and steps in process validation. Process validation is critical to the production of high quality, consistent, safe and effective products and devices. Routine end-product testing alone is insufficient to assure the quality, safety and effectiveness of a product or device. It is important that the product acceptance criteria and specifications are quantified, and that the manufacturing processes are well characterized, understood, controlled and validated.

This GLP (Good Laboratory Practices) webinar reviews the process of closing a study by preparing a final report and managing all records and specimens in a proper manner. The GLP final study report represents the last chance for a study team to present their results in a clear and compelling manner. The report may also be a place where difficulties can be explained so that the study provides meaningful and trustworthy information. This webinar reviews the process of closing a study by preparing a final report and managing all records and specimens in a proper manner. It provides two areas of concentration: (1) the best practices in final report writing and (2) the step-by-step process of closing studies.

This presentation will review the GMP guidance document and discuss how it may be integrated with the recommendations of the guidance documents on CMC requirements. This presentation will be aimed at helping Regulatory, Quality Assurance and Quality Control personnel to understand the varying levels of quality activities that accompany early stages of Product development.

This session will highlight typical manufacturer pitfalls in designing user studies and usability tests as well as common mistakes and omissions regarding use error in PMA and 510K submissions. This webinar will apply to manufacturers with devices that require user-device interactions to set-up, operate, and maintain the device.

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).

This program outlines a system for preparing for an unexpected inspection and details SOPs that should be established in advance of the appearance of an inspector at your front door. This Webinar will provide valuable assistance to all regulated companies that face unscheduled inspections by regulatory agencies.

The presentation will use examples taken from warning letters to illustrate some of these problems, and discuss possible solutions. As an example, we will discuss the process for accepting raw material.

This presentation will discuss the quality-related activities that are expected for different stages of the product development process. Emphasis will be placed on the transition into full GMP work as clinical trials proceed, but the requirements for DMFs and NDAs (or BLAs) will be discussed.

The presentation covers the requirements of the Code of Federal Regulations for drugs, biologics, and medical devices, as well as key FDA Guidance Documents including the International Conference on Harmonization (ICH) E6. This program is essential for management of clinical trial sponsors and vendors.

This presentation will cover the regulations that apply to biologics in general as well as those that apply to members of the special classes. This webinar will be directed at workers with some experience who must now deal with the manufacturing of various biological products.

This presentation reviews key ICH guidelines to directly correlate them with FDA Compliance Program Guidance Manuals that FDA investigators use to conduct GCP inspections. This webinar will provide critical assistance to FDA regulated companies currently conducting or preparing to conduct clinical trials.

This webinar will provide valuable assistance to regulated companies which employ regulatory affairs associates, clinical specialists, internal auditors, audit managers and personnel of JPAL-regulated medical device or IVD companies. A comprehensive audit of relevant clinical investigations is now expected to determine if the clinical trials and clinical trial systems are effectively documented and implemented.

This FDA’s cGMPs training/webinar will provide and insider’s view FDA’s path to restructuring its regulatory oversight of manufacturing quality that is based on quality systems and risk management approaches.

This presentation will review methods for finding predicates, using guidance documents and interacting with the agency. Participants will learn about the different types of 510(k) submissions and the benefits and drawback of using the 3rd party.

This Pharmaceutical training will review the key aspects of Pharmaceutical GMPs for the 21st Century and Quality Systems Approach to Pharmaceutical CGMP Regulations.