FDA Regulatory Compliance Training - Live Webinars, Recordings & CDs

The following webinar will cover common CAPA problems across industries and how to avoid them. This webinar will provide valuable assistance to all regulated companies that need to have CAPA systems as mandated by the FDA.

This webinar 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 presentation will cover the GLP requirements for animal studies, and the methods that laboratories employ to comply with the regulations. This webinar will be directed at personnel who must conduct or review the performance of non-clinical laboratory studies related to safety. GLP studies apply to animal studies that are required in all regulated areas.

Companies are unsure on what exactly to qualify or re-qualify test and document. The main reason is that unlike for analytical methods there are no clear standards for equipment qualification. The USP has developed a new standard for analytical instrument qualification (AIQ). It will be official by August 1, 2008.

Attend this seminar to learn about proven industry practices for network qualification. Configuration management and change control as the most important network qualification steps.

The webinar will address each audit item and train the participants how to determine the compliance status. We will use common examples of non-compliance observations from actual audits and suggest remediation plans that are compliant, efficient and economical.

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 discuss how to perform pre-study GLP compliance audits and what to look for at candidate nonclinical CRO This webinar will be valuable for any member of a pharmaceutical or biotechnology organization charged with placing or monitoring nonclinical GLP safety studies.

A proven process for investigators will be presented to address common deficiencies with respect to costs associated with clinical investigator site requirements for studay conduct.

Attendees of this Webinar will learn how to transfer analytical methods in FDA and equivalent international environments. When validated methods are transferred between laboratories and sites, their validated state should be maintained to ensure the same reliable results in the receiving laboratory.

This webinar will provide valuable assistance to all regulated companies that use cell or tissue based laboratory practices, including companies in the Medical Device, Diagnostic, Pharmaceutical, and Biologics fields. This webinar will describe and show applications of GCCP which can be used in vitro assays to increase quality standards in the laboratory environment.

This will teach part 1 of defining and refining objectives and selecting the best of alternative courses of action.

The importance of GLP compliance, as well as preparing an FDA-ready IND package will also be presented. This webinar will be valuable for anyone developing cell, tissue or gene therapy products, including those in the biopharmaceutical industry.

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 webinar will provide valuable assistance to all regulated companies that need to validate their systems The series will deal with Operational Qualification (OQ), Performance Qualification (PQ), and maintaining a state of validation using statistical methods associated with Six Sigma

AN overview of the Part 11 regulation, with special emphasis on the key role played by the applicable predicate rules as the starting point for any Part 11 compliance assessment. In spite of the FDA’s clarification regarding the scope of electronic records subject to Part 11 as expressed in the Sep 2003 Guidance for Industry, much discussion and debate still surround the topic.

This seminar presents the basics of Quality by Design in such a way as to allow attendees to understand Quality by Design as it applies to their company and their products. Six years after the announcement of the FDA’s cGMP Initiative for the 21st Century, the FDA has finally coalesced on an approach it calls “Quality by Design.” Despite numerous presentations by FDA officials, several pilot programs and the adoption of Quality by Design by the International Conference on Harmonization (ICH), confusion about Quality by Design reigns throughout the pharmaceutical, biotechnology and medical device industries.

Learn how to use and how far to go with an effective and efficient approach for your CAPA investigation. This webinar will provide valuable assistance and guidance to all regulated companies that are preparing to use or are currently using risk-based tools for CAPA investigations and closing out investigations in a timely manner.

The mutually exclusive roles for Quality Assurance and Quality Control in validation will also be discussed. Across 20+ years of global regulations and guidance related to computer systems, there are four common themes that provide the foundation for auditable validation efforts.

This webinar will provide valuable assistance to all companies regulated by FDA to understand the current and impending requirements for electronic submissions. The immediate impact is to companies submitting INDs and marketing applications for pharmaceutical and biological products.