FDA Regulatory Compliance Training - Live Webinars, Recordings & CDs

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.

We will discuss methods and practices that will improve the clarity and control of your document control system. Effective GMP documentation practices will be reviewed to ensure your paperwork is clear, complete, and easy to understand.

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 Sampling training will answer all your questions about acceptance sampling for defectives.

This presentation will discuss the advance preparation that is needed on the part of the auditor, and discuss the things that the auditor should look for during the audit. It will also be beneficial to workers in laboratories that will be audited or inspected by external parties.

In this FDA cGMP Inspection training learn all the background information and key Techniques needed to guarantee a cost-effective, first-time pass through an FDA inspection - whether for a pharmaceutical product, an active pharmaceutical ingredient (API), a medical Device or a biological production. The world of GMP compliance has dramatically changed with FDA stressing pre-approval inspections, risk management, investigations and CAPA, quality systems approaches, and process and analytical technology (PAT) applications. If you last passed an FDA inspection more than four years ago, or if you have never faced an FDA inspection, you will be unprepared for FDA’s 21st-century inspection methods. This course provides all the background information and key techniques needed to guarantee a cost-effective, first-time pass through an FDA inspection— whether for a pharmaceutical product, an active pharmaceutical ingredient (API), a medical device or a biological product. All API, medical device, diagnostic product manufacturer, biotechnology product or pharmaceutical manufacturers—no matter in which country they operate—must pass an on-site FDA inspection of their facilities and operations if products are to be sold in the United States.

This webinar is designed to provide background and insight into the inspection process, as well as practical strategies and tactics that a company must know and implement in order to have the potential to pass an inspection the first time through. The webinar covers everything you need to know—from the background to the inspection, including the importance of the commitments made in the product application (the DMF, the NDA, the BLA or the PMA). In addition we will discuss the differences between good science and GMP compliance issues. The inspection process itself will be analyzed and reviewed in a manner that will allow you to immediately begin effective strategizing on how to pass the inspection. Nothing has been left out. The course touches on everything, and we do mean everything, you need to know to have a smooth and successful inspection.

This presentation reviews the major areas described in FDA 21 CFR Part 58, particularly emphasizing the five key elements of preclinical studies: written procedures, personnel, equipment, data collection, and reporting. This webinar is targeted to scientists and management new to GLPs.

This presentation will provide you with the tools to prepare for and support the audit process executed by regulatory bodies.

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. Emphasis will be placed on the transition into full GMP work as clinical trials proceed, but the requirements for NDAs (or BLAs) will be discussed.

In this FDA compliance training learn regulatory expectations for stability indicating methods & Purpose and requirements for stability indicating methods. There is a lot of concern related to the stability of various drugs over different periods of time and different companies are following different approaches to this problem.

This session describes how to use the GAMP® standard to determine what has to be validated and explains how to create documentation that will meet regulatory requirements worldwide.

In this Good Laboratory Practices training on FDA warning letter learn how to avoid making the same mistakes in your study and to avoid having your company's name publically cited for inspection findings.

In this seminar, you will learn how to document unexpected situations accurately and completely. Are your investigations done haphazardly or in an inconsistent manner? Are your reports hard to understand? Is the discrepancy resolution process slowing your product release efforts unnecessarily?

This presentation will discuss the differences between qualifications and validations as they apply to shipping and packaging. The objective of a shipping qualification program is to verify that product can be shipped throughout the supply chain within required temperature ranges and without damage. To accomplish this companies must conduct operational and performance qualifications for their shipping configurations. The operational qualifications consisted of temperature mapping of test loads that are challenged with “worst case” temperature profiles under controlled laboratory conditions. The performance qualifications were performed concurrent with actual product shipments.

This session 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. This session will be the limits of FDA’s scope during an inspection, including what documents you are not required to show them, and the permissibility of photographs and affidavits.

Participants will learn how to write CA reports that will be used as written & how a well maintained CAPA system will save the company time and money. This course summarizes the cGMP requirements for Corrective Action Preventive Action (CAPA) and prepares participants to complete CAPA investigations on their own.

An assessment of your people to determine who should be talking with the FDA and most importantly, who should not must be performed. This webinar will provide the process map for the compliance and quality staff to build their strategy and plans for preparing for and executing their preparation work for a PAI in the Pharmaceutical and Biotechnology world.

This regulatory training will provide benefits to companies’ required to have a process for collecting, assessing and documenting deviation and complaints and ensuring that corrective and preventive actions are compliant with GXP requirements.

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.

To follow the regulations is Good Clinical Practices (GCP) and common sense. To not know and follow these regulations is folly. This Webinar will provide invaluable assistance to investigators and staff with regulatory/ legal responsibilities. It also delves into the complex ethical considerations in pharmaceutical product (drug or device) research involving human subjects.