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

This statistical process control training will provide an overview of statistical process control (SPC) describe various types of control charts and how they can be used for trend analysis, defect reduction, product capability assessment. Quality, safety and efficacy must be designed into a product. Quality cannot be inspected or tested in the finished product.

This Method Validation training in drug development process will provide guidance in setting appropriate specifications, determining if the assay is validatable, and monitoring progress during the validation. This web seminar will address frequently observed issues and problems with method validations.

This FMEA (Failure mode and effects analysis) training will cover the Joint Commission requirements for conducting a proactive risk assessment using the FMEA methodology.

This process validation training for Pharmaceutical Manufacturers will allow your process validation program to be executed quickly and efficiently and will ensure that the process validation you perform supports a successful pre-approval inspection. Successful process validation of a cGMP pharmaceutical manufacturing process is essential for obtaining a commercial license.

This Radiopharmaceuticals training will set out guidance and advice for those interested in setting up or improving an existing facility. Radiopharmaceutical manufacture is starting to begin a new phase as FDG now has a product licence

This 510(k) Clearances training/webinar will provide valuable assistance to all regulated companies that need to validate their systems.

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 Management control training will provide the principles and practices needed to effectively develop and implement the Management Controls to ensure an effective Quality Management System and to comply with the FDA QS Regulation.

This Complaint Handling training will discuss the best way to document customer feedback, what constitutes a complaint, and what do with "non-complaint" feedback.

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 Pharmaceutical training will also provide attendees with the details and expectation stipulated in ISO 14644 series standards and FDA’s 2004 guidance document for aseptic processing. This seminar is designed to provide a thorough understanding of the principles applied to the design, qualification and operation of cleanrooms.

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.

This program is designed for the medical device, IVD, and combination product industries This webinar will provide the core principles and practices needed to implement an effective and efficient CAPA process

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

In this Medical device training will provide valuable assistance to regulated companies on how to drive regulatory compliance for IT based medical devices.

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.