Compliance Training Webinars for Regulated Industries

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

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.

This Environmental Management training will discuss the advantages of a company’s management system to the international standard’s requirement and a simple to follow, Three Step Process for its implementation.

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.

The purpose of this webinar will be to present and identify ways that your quality objectives can Provide and identify improvement opportunities for your system's maintenance and ongoing health. The purpose of this webinar will be to present and identify ways that your quality objectives can Set the tone for using your quality policy statement,Provide a guideline for Top Management’s direction for the organization,Identify improvement opportunities within your system leading to greater reliability.

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.

In this Auditing IT training learn how to assess an IT initiative’s implementation “preparedness” and how to reduce your IT risk.

This will review how EO sterilizes, basic factors affecting sterilization, calculating the D value, Biological Indicators, the processing steps, EO residuals, and product release in a practical manner. Many companies are using EO to achieve product sterility. Whether EO sterilization is performed in-house or with a contract sterilizer the product manufacturer must be informed as to how the process works.

This Hazard Analysis training will show you how to make the Hazard Analysis process work for you, what value it has for the entire life cycle of your product and how to use the process to help focus your design and process development efforts.

Many small or virtual companies make one of two common mistakes: their Quality Management System (QMS) is either too cumbersome for their operation or they don’t have a quality management system at all Quality management issues facing small, startup or "virtual" companies and identifying all required quality management system elements.