FDA Regulatory Compliance Training - Live Webinars, Recordings & CDs

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.

In this Risk Based Validation training we will go through various scenarios and recommend actions for validation and other controls.

This Validation training will provide valuable assistance to all regulated companies that need to validate their systems and will introduce measurement validation using Gauge R&R. Will introduce measurement validation using Gauge R&R. R&R standing for Repeatability and Reproducibility

This Medical device training will talk about recent developments in the European Commission’s approach towards the parallel distribution of medicines. In the past the European Commission has taken a strong stance against restrictions imposed by pharmaceutical companies on wholesalers and distributors of medicines, preventing them from parallel importing the contract products within the European Union ("EU").

This Pharmaceutical training will review the key aspects of Pharmaceutical GMPs for the 21st Century and Quality Systems Approach to Pharmaceutical CGMP Regulations.

In this Risk management training we will review the concept of Risk Management, its various elements, what is required, and its benefits. How are you meeting the FDA and ISO risk management requirements? Hazard Analysis? FMECA? dFMEA/pFMEA? The concept of Risk Management and the difference between risk analysis, evaluation, assessment, and management.

The principles and practices needed to effectively develop, implement, and perform internal quality management system audits that comply with the requirements of the FDA QS Regulation and ISO 13485. This medical Device training will provide the principles and practices needed to effectively develop, implement, and perform internal quality management system audits that comply with the requirements of the FDA QS Regulation and ISO 13485.

Key insights to the background of the revision for medical device manufacturers with products in Europe. The Medical Devices Directive 93/42/EEC (MDD) is the key European Directive for regulatory compliance and placing of a CE mark on a medical device.

This FDA Inspection training is designed to provide the tools and practices necessary to effectively prepare for and manage a successful FDA inspection.

This webinar will cover the essential aspects for the cGMP-compliant technology transfer of a pharmaceutical manufacturing process.

This webinar is targeted at people responsible for outsourcing, and at contractors who wish to ensure they provide excellent services which will generate them repeat business.

This Validation training will give a good understanding on what the requirements are and how to validate laboratory computer systems in the most cost-effective way.

Computer system validation and risk-based verification and validation planning to meet US FDA and ISO 13485 requirements This pack of two training courses provides 2 hours of training on Computer system validation and risk-based verification and validation planning to meet US FDA and ISO 13485 requirements.

The European Union has stated their requirements in Annex 13, while FDA has recently issued a controversial new phase 1 guidance Join us for a discussion of actual requirements, and both historic and current guidance document recommendations

This FDA Inspection will discuss FDA inspection readiness techniques and how to prepare your organization for a facility inspection.

This presentation will provide and insiders view FDA’s path to restructuring its regulatory oversight of manufacturing quality that is based on quality systems and risk management approaches In 2002, FDA announced a significant new initiative, Current Good Manufacturing Practices (cGMPs) for the 21st Century intended to modernize FDA’s regulation of pharmaceutical quality and established a new regulatory framework for manufacturing.

In this design Input training we will define design input, review robust requirements development, assess the impact of user needs vs. patient needs and discuss options for timing your design reviews.

In this Quality Risk Management training develop and implement a policy for a Quality Risk Management Program and determine how to select the direct-impact systems and processes to apply your policy - formal QRM.

Essential elements of tort law, product liability and defensive strategies to protect your company In this Training, essential elements of tort law, product liability and defensive strategies to protect your company will be outlined in detail.