Life Sciences Regulatory Compliance Training - Live Webinars, Recordings & CDs

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

This Internal audit training will guide on how to set up an ISO 14971 audit program with specific auditor guidelines.

This Quality compliance training will present and identify ways that your (ISO 9001 8.2.3) process monitoring and measurement tools can Lead your organization to fast and efficient corrections when problems occur.

This Pharmaceutical training starts with the drivers for outsourcing and investigates the importance of measures of success and how they apply in implementing strategy.

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.

This Medical device training will explain the regulatory requirements including cleaning and sterilization methods & validations.

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 is the third of three presentations on the methodologies for the determiniation of the minimum sterilization dose.

In this Medical device training will provide an explanation of what a New Approach Directive is and what they all have in common from a compliance perspective. The placing of a CE mark on a medical device implies compliance with all European "New Approach" directives that apply and typically three or four directives will have to be considered.

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 Biopharmaceuticals training learn how can this guidance be applied given the rapid pace of development, the difficulty of defining the process and the product early in development, and the ever-changing regulatory environment. New draft guidance from the ICH indicates that process development should include risk assessment, definition of ’design space’, and suitable designed experiments to define a safe operating range.

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.

This Validation training describes logical approaches to efficiently develop assays that will deliver quality data. The main body of the talk reviews current industry guidelines with a goal to preparing a scientific validation protocol and method. The seminar also analyzes critical validation parameters, describes common technical pitfalls between various technologies and suggests solutions

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.

This Internal Audit Training will discuss the tools and techniques to design, implement and maintain the internal audit system to prevent audit system problems. The internal audit system must be successful for the business to be successful.

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.

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.