Compliance Training Webinars for Regulated Industries

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).

What credit professionals need to understand to carry out their responsibilities and duties to ensure Sarbanes-Oxley compliance. The Sarbanes-Oxley Act of 2002 makes company executives of publicly traded US companies personally and criminally responsible for the accuracy and reliability of the financial disclosures of their companies.

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

This webinar will provide valuable assistance to all FDA-regulated organizations seeking to implement Risk Management through effective FMECA efforts. Diane will also provide internet links to valuable on-line FMECA and Risk Management references as well as to downloadable FMEA templates for use with MS Excel in association with this presentation.

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.

The webinar provides a comprehensive and logical way to think about performance goals, metrics and the evaluation of goal progress.

Learn how to comply Sarbanes Oxley compliance in a cost-efficient manner. Many have questioned whether the Sarbanes-Oxley law requirements can be met in a cost-efficient manner. Absorbing the first-year lessons — and, going forward, is a challenge facing all public companies as they prepare to meet quarterly and annual reporting requirements. And further challenges will arise as new compliance issues emerge and PCAOB regulations evolve.

This presentation will give an overview of these new tools and techniques for the non-statistician/epidemiologist. It is vital that a pharmaceutical manufacturer be able to quickly assess these issues on a sound statistical basis, in a way that eliminates bias due to confounding factors as much as possible.

The process is critical for device manufacturers to effectively evaluate and select suppliers and subsequently implement agreements ensuring consistent material quality and/or services provided. This webinar will provide a valuable and informative overview and guidance to manufacturers, especially medical device companies that are preparing to establish or have established supplier/vendor management qualification programs.

This presentation will review the ISMS and architectural considerations that need to be addressed. An ISMS can help an organization effectively and efficiently manage information security related risks.

This Biopharmaceutical Compliance training provides guidance on industry trends, regulatory feedback, and designs for an effective validation program. Designing an effective disinfectant validation program to meet FDA and EMEA scrutiny. This webinar provides guidance on industry trends, regulatory feedback, and designs for an effective validation program. Current 483's, Warning Letters, and Field Experiences will be conveyed that allow end users to determine that best methods to validate their products against their isolates.

Kaizen Events are an extremely efficient way to quickly improve process efficiencies and effectiveness.

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.

How to create and blend the Risk Management File findings into the company’s internal and external audit plans?