Compliance Training Webinars for Regulated Industries

This Webinar covers REMS provision and Impact on Pharmaceutical Marketers.

This Risk Management training will cover Risk management & Risk assessment within all business processes. Risk management is a concern that must be taken seriously in all aspects of your business. Are you prepared for the problems you may face?

This presentation will discuss the quality-related activities that are expected for Phase 3 products used in clinical studies and the needs of the key demonstration lots that will be submitted with the NDA. 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 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 program will examine the benefits of outsourcing in China along with the risks and review possible solutions needed to enhance supply chain security while consistently delivering safe products to the consumer/patient.

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 training course will concentrate on how to prepare for the audit, from language and culture to technical requirements and auditor expectations. Due to the 2005 revisions in the Japanese Pharmaceutical Affairs Law (PAL), the PMDA - Pharmaceuticals and Medical Devices Agency - is beginning to step up its scheduling of on-site audits of foreign medical device manufacturers.

This presentation covers the fundamental principles underlying the various compliance regulations and discusses their implications for system designers and integrators. Electronic data capture and management systems for clinical research must support many kinds of research, including clinical trials, prospective observational studies, and retrospective "chart mining". Regulatory requirements for new drug and device trials are the most stringent and complex, but even the smallest investigator-initiated study in an academic health center or community hospital or clinic must comply with human subject protection regulations and professional ethical guidelines, and meet information security requirements such as the HIPAA Privacy and Security Rules. This presentation covers the fundamental principles underlying the various compliance regulations and discusses their implications for system designers and integrators.

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).

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.