FDA Regulatory Compliance Training - Live Webinars, Recordings & CDs

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 presentation covers the fundamental principles underlying the various compliance regulations and discusses their implications for system designers and integrators.

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.

This Design Controls Webinar will provide a overview of all the steps involved in design controls and explain and clarify and state specific requirements in the regulations.

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 Designing Viral Clearance training discuss the design and implementation of a viral clearance study that includes appropriate viruses to model existing and emergent viral threats and evaluates the impact of potential fluctuations in processing.

This Six sigma training in Medical device will demonstrate the value of using DFSS principles in developing such devices by identifying critical design, production and distribution parameters that affect the performance of the finished device. Design for Six Sigma (DFSS) can be used to design, manufacture and sell high quality, defect-free, safe, effective devices that meet the intended use while also generating healthy profit margins for the company.

In this Design Input training 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. During this seminar, we will complete a sample Design Input requirements document that you can use as a guide for writing your own requirements

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 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 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 presentation will review methods for finding predicates, using guidance documents and interacting with the agency. Participants will learn about the different types of 510(k) submissions and the benefits and drawback of using the 3rd party.

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 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