In March of 2018, the Medicines and Healthcare products Regulatory Agency (MHRA) released the “‘GXP’ Data Integrity Guidance and Definitions” guidance document, which outlined the agency’s thinking on data integrity best practices. In October of 2018, FDA and MHRA held a joint GCP (Good Clinical Practices) Data Integrity Workshop, where the agencies clarified their expectations for data integrity in clinical studies and identified key risk areas using case studies and agency observations. This course will give you a baseline for data integrity requirements, and overlay lessons learned from the FDA/MHRA workshop.
Standard operating procedures (SOPs) are a fact of life in regulated industry. They are a critical part of almost every aspect of product production in the life sciences, and are therefore some of the most heavily scrutinized documents during regulatory audits and inspections.
Medical Affairs Organizations are a growing requirement for pharma/biotech firms. However, starting them is never easy. This course will provide an overview of what great Medical Affairs organizations look like, how to build one, and where to start. This is the second session of our comprehensive nine-part certificate series.
This session will be valuable to clinical trials and associated/related personnel looking for a foundational understanding of regulatory requirements, implementation, and best practices surrounding Electronic Document Management Systems (EDMS) And Electronic Common Technical Documents (eCTD).
In 2016, the FDA released a revised draft guidance, “Submission of Quality Metrics Data Guidance for Industry”, describing its Quality Metrics Reporting Program for drugs and biologics. New compliance and inspection policies could be developed as a result of submitted quality metrics. Establishing quality metrics now will help your company prepare for any future regulations as well as drive your Quality Culture toward continuous improvement.
Successful technology transfer in the manufacturing of pharmaceutical products is a stressful and expensive process that is fraught with risk. Whether you are moving from early R&D to producing product for clinical trials, scaling up commercial manufacturing, changing your process, or moving to an outsourced model, careful planning and execution is needed.
This course will describe considerations for developing a plan for Part 11 compliance that prioritizes activities based on risk and importance for organizations involved in clinical research. Participants will learn how to identify which computing systems and service providers fall under Part 11, what SOPs they’ll need, and activities that should be conducted for their current systems.
Increasingly, global regulators want to know how effective your Corrective and Preventative Actions (CAPA) are. Investigators will look at this specifically because it will give them a comprehensive window into the steps you take leading up to measuring your CAPA effectiveness. These include Root Cause Analysis investigations, and determining CAPAs. After all, you can’t measure the effectiveness of a CAPA if the CAPA was incorrect to begin with. This webinar will show you how to measure CAPA efficacy AND ensure that you take the right steps to get to that point.
Investing in a Regulatory Mock Inspection (Mock) exercise is a trending industry inspection readiness approach. Execution of a Mock based on lessons learned from industry will ensure that your inspection readiness exercise accurately identifies gaps that are truly specific to your organization, providing the most bang for your buck.
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