FDA Regulatory Compliance Training - Live Webinars, Recordings & CDs

This webinar will provide valuable assistance to all medical device and IVD companies that must comply with domestic and international regulations for their quality systems. Most notable of these would include USA (21CFR820), Canada (CMDR + ISO 13485), Europe (MDD Annex II.3 + ISO 13485) and Japan (JPAL Ordinance 169 + ISO 13485).

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.

his presentation will cover auditing and management techniques in relation to purchasing control compliance. Real supplier auditing processes and other management tools associated with purchasing controls will be discussed Many firms feel that they are adequately auditing and managing suppliers, yet find they are having myriads of quality issues. FDA and other auditing organizations are going to focus on supplier auditing compliance in 2007-2008

The Webinar discusses recordkeeping requirements of serious and non-serious adverse events reported to a dietary supplement manufacturer, packer, or distributor. The Dietary Supplement and Nonprescription Drug Consumer Protection Act law mandates reporting to the Food and Drug Administration (FDA) of serious adverse events for dietary supplements.

In this webinar instructor will explain what are essential elements of CAPA system to meet current regulatory requirement and how to achieve it The basic CAPA procedure should clearly define the fundamental elements for developing CAPA files which address significant quality system non-conformances

This session will introduce advanced control charting for multiple stream processes. We will also introduce control chart analysis and how to select the correct control chart and interpretation and reaction to control chart signals.

Attendees will learn and understand the do’s & don’t of the cleanroom procedures during cleaning, disinfecting, transferring of material and filling operations. This one-hour online seminar is designed to discuss the principles applied to the operation and cleaning of cleanrooms to ensure the contamination control.

This 21 CFR Part 11 training/webinar will provide valuable assistance to all regulated companies that need to comply with 21 CFR Part 11.

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 New Dietary supplements webinar will highlight from a quality perspective the introductory requirements of these new CGMP regulations and examine methods and strategies for meeting these new requirements.

This Part 11 - Electronic Records webinar will provide an insider’s view FDA’s current thinking regarding the scope and application of Part 11 of Title 21 of the Code of Federal Regulations; Electronic Records; Electronic Signatures (21 CFR Part 11).

This FDA compliance webinar provides FDA’s current thinking on modernizing the regulation of quality and manufacturing science through establishment of a new regulatory framework.

It will provide an overview of the FDA inspection process in general along with a background and understanding of the role played by the Agency, its administrative and enforcement powers Pharmaceutical, biotech, medical device and generic drug companies will be most interested in attending this program. The seminar teaches important tips on how to prepare for and handle FDA and related regulatory inspections.

This FDA quality inspection training will focus on FDA’s current thinking on cGMP requirements, including background information on FDA’s inspectional requirements under the Food, Drug and Cosmetic Act. The Food and Drug Administration is using a new approach to inspections as a part of their cGMP Initiative for the 21st Century

This FDA compliance training will review the FDA Software Standard "General Principles of Software Validation". The process that FDA investigators use relative to software failure investigations will also be discussed.

This Validation training will provide guidance in overcoming inherent variability in bioassays. Performing good optimization studies will lead to a well-defined method for future qualification and validation of the assay

This Risk management training offers a quantitative risk management approach you can use to measure system implementation and enhancement efforts against the criticality and business/regulatory significance of the system.

This Validation training will provide valuable assistance to all regulated companies that need to validate their systems. Project management is the application of knowledge, skills, tools, and techniques to manage project activities to meet project requirements

This training will identify and review the key planning documents, including team assignments, management and conduct of the project, project phases, and regulatory requirements and scheduling.

This Quality training will help you look holistically at your quality systems and embrace a continuous improvement approach that will drive quantifiable business benefits. A quick review of your log of corrective and preventive actions can be quite revealing. Many executives have found that their past improvement initiatives only addressed problem areas regarding individual products.