Overview: This webinar will explain the implementation of ISO 62366 and the regulatory expectations discussed in the 2016 FDA Guidance for a compliant human factors/ usability program. Why should you Attend: This year FDA published their priority list for the completion of their Guidance documentation. This annual activity gives us inspection and enforcement insight into the priorities within the agency. Interoperability and Cybersecurity were...

Overview: Companies engaged in the conduct of human clinical trials must adhere to specific government regulatory requirements. Certain documents, content and images related to a clinical trial must be stored and maintained, and depending on the regulatory jurisdiction. Why should you Attend: You should attend this webinar if you are responsible for establishing or maintaining a TMF, or providing quality assurance for data included in the file...

Overview: Electronic medical records and electronic handling of study data is increasingly common. To involve computer systems in clinical research implies knowledge of 21 CFR Part 11. Why should you Attend: The increasing use of computers and increasing complexity, all persons who have any data input requirements to know the set-up and function of the systems they are using. Forewarned is forearmed. Areas Covered in the Session:The CFR defini...

Overview:The FSMA is paradigm shift that moves the focus from food inspections to preventative measures and process compliance. Why should you Attend:Specific provisions of the FSMA that impacts transportation and 3rd party logistics providersSanitary transportation best practicesTo develop a food safety plan that identifies potential risks, preventative controls and ongoing monitoringNew rules that govern food importers and exporters Areas Co...

Overview:This webinar will review the key concepts behind Design of Experiments. A strategy for utilizing sequential experiments to most efficiently understand and model a process is presented. Many common types of experiments and their applications are presented. Why should you Attend:Learn a methodology to perform experiments in an optimal fashionReview the common types of experimental designs and important techniquesDevelop predictive model...

Overview:In this session you will learn procedures and practices on how to validate and use Excel® requirements , and how to design spreadsheets for compliance , also how to ensure and validate spreadsheet integrity. Areas Covered in the Session:How to design spreadsheets for complianceHow to ensure and validate spreadsheet integrityWhen, what and how much to test?Validation of standard/native Excel functions? Who Will Benefit:QA Managers...

Overview:Refund PolicyBy attending this webinar you will learn about the RCA toolbox and how to get permanent resolution to your significant quality problems. Why should you Attend:You will waste precious time and money and still end up with unsatisfactory results. This webinar will give you insights and lessons learned from a certified Master Black Belt and industry expert with over 30 years' experience. Areas Covered in the Session:Build the...

Overview:FDA regulates both finished dietary supplement products and dietary ingredients. FDA regulates dietary supplements under a different set of regulations than those covering "conventional" foods and drug products. Why should you Attend:To gain a fundamental understanding of FDA's regulation of Dietary Supplements. Areas Covered in the Session:Definition of dietary supplementDSHEAGood Manufacturing PracticesStructure/Function ClaimsHealt...

Overview:The pros and cons of the 2 most widely used sampling plans (ANSI Z1.4, and Squeglia's C=0) are examined in detail, focusing especially on the weaknesses of such plans in regards to meeting regulatory requirements. Why should you Attend:Almost all manufacturing companies spend time and money to inspect purchased parts upon receipt, in order to evaluate part quality before the parts Supplier is paid. "AQL" sampling plans are used almost...

This course will cover the proper methodologies on conducting a HIPAA Risk Assessment based on the formula used by Federal auditors and via the guidelines of the NIST (National Institute of Standard for Technologies). The course will also cover the most important aspects to be aware of in terms of the Federal auditing process as well as the new risks regarding patients suing for wrongful disclosures. Why should you Attend: Have you done a HIPA...