A combination product is a product composed of any combination of a drug and a device; a biological product and a device; a drug and a biological product; or a drug, device, and a biological product. Why Should you Attend: To gain a fundamental understanding of FDA's regulation of Combination Products. Areas Covered in the Session: Definition of combination product FDA Regulatory Pathways Primary Mode of Action User Fees Who Will Benefit: Regu...

To satisfy QSR and ISO 13485 requirements, medical device companies must respond to field reports swiftly and compliantly. There are certain circumstances in which a report from the field requires the device manufacturer to take steps regarding product in the field. Why should you attend: There are certain circumstances in which a report from the field requires the device manufacturer to take steps regarding product in the field. It is critica...

This is an interactive overview of how DMAIC can be utilized in a home environment to improve the quality of life for a child diagnosed as being on the Autism Spectrum. Why should you Attend: Why One in every 68 children is now diagnosed with Autism. With no "cure", what are parents and relatives to do? This session shares a how one set of parents proactively applied the DMAIC process to help with their quality of life. The same tools and skil...

The US Food and Drug Administration has recently released information about its new strategies as a result of the new administration. The new commissioner recently announced a new policy for Warning Letters and FDA-483 responses, putting manufacturers under very tight response timelines. Areas Covered in the seminar: The "new" FDA organization and mission Enforcement changes- increased inspection Enforcement Changes-new expectations Manufactur...

Reliability Plotting is a graphical technique that is a standard method described in some reliability textbooks. The method is used primarily for data that is problematic in one or more of the following ways: non-normal. Why should you Attend: The most informative method for analyzing the data that results from QC, Validation, or Engineering activities is the calculation of the product's or lot's "reliability" at a chosen "confidence" level (w...

This course covers the newly proposed requirements for conducting Clinical Studies across the EU via the requirements of the EU Clinical Trial Regulation 536/2014 (for Drugs, Biologics & Combination Products). The course also covers recent updates on EU-GCP associated with the Directive, the highlights of the new EU Pharmacovigilance Directive, as it relates to studies and helpful tips into working with the European regulators. Areas Cover...

Excel® Applications are widely used in laboratories, offices and manufacturing e.g., for data capture, data manipulation and report generation. Regulations such as FDA's GxPs and 21 CFR Part 11 require users of software and computer systems to demonstrate and document data accuracy, integrity and confidentiality. Areas Covered in the Session: FDA and other agency's requirements for spreadsheet validation - What do inspectors ask and what d...

Medical Device managers, engineers, QA personnel, as well as lean program leaders. Do you find yourself constantly struggling to create, manage, and maintain all of the information found in Corrective and Preventive Actions (CAPA)which is often redundant, repetitive, and chained together in a cumbersome way? Areas Covered in the Session: Brief introduction to Lean Documents and Lean Configuration Quality System Regulation, 21 CFR Part 820, and...

Overview: The use of spray polyurethane foam insulation in building construction has increased dramatically over the past decade because of its superior insulating qualities, performance and ability to provide all four barrier needed to effectively separate the interior environment form the exterior environment. As expected, problems have arisen due to improper installation equipment and techniques, a lack of understanding of the properties of...

Overview: The last few years have seen an increase in product recalls. For this and other reasons, the U.S. FDA come under increasing negative public scrutiny. High profile drug recalls, food chain problems and contamination, import problems, resignations. Â Now a new commissioner vows no more "business as usual". Â Data in submissions and decisions rendered will be more science-based and subjected to greater scrutiny. Â Fail...